Present-day technical and legal methods of preventing child pornography offences and online grooming are not sufficiently effective and do not meet their purpose. A thesis from the University of othenburg, Sweden, shows that new approaches are needed to improve online protection for our children.
Marie Eneman of the Department of Applied Information Technology has studied in her thesis how information technology is used for child pornography and grooming, that is to say adults making contact with minors for sexual purposes, and the technical and legal controls that exist to protect children. She has studied all Swedish judgments on child pornography offences over the period 1993-2008 and has interviewed a number of people convicted of child pornography offences.
"Information technology has made it easier to produce, distribute and access child pornography, and has also increased the risk of grooming. As well as availability, technology brings a certain degree of anonymity, a global market and the possibility of making contact with like-minded people," says Eneman.
In her thesis, she identifies hortcomings in present-day legal and technical regulation models.
"The picture of the role of information technology in these offences is more complex than the legislators, police and prosecution authorities could have envisaged, and technology poses a great challenge," she says.
While implemented technical egulation, in the form of filtering, currently focuses solely on websites, Eneman shows that significantly more types of information technology are used to distribute child pornography. One example is file sharing. Information technology is not a homogeneous technology, it consists of several technologies with different characteristics. It is therefore important to adopt a broader perspective in looking at the technology in order to be able to develop effective regulatory models. The thesis additionally shows how offenders have been able to adapt and have developed various social and technological strategies to reduce the risk of being exposed and finding ways of circumventing filtering, for example.
Eneman's thesis asks whether we might need to accept certain restrictions on our rights in order to improve protection for our children. "Rights such as freedom of expression and personal privacy are fundamental and should continue to be defended, but they must be adequately balanced in relation to other important rights such as the right of the child not to be sexually exploited," she says.
Notes:
Title of thesis: Developing Child Protection Strategies: A Critical Study of Offenders' Use of Information Technology for the Sexual Exploitation of Children
Opponent: Professor Debra Howcroft, Manchester Business School, MBS West, United Kingdom
Source:
Marie Eneman
University of Gothenburg
Buy Meronem IV Without Prescription
среда, 14 сентября 2011 г.
Pre-Operative Assessment By Physical Therapists Of Breast Cancer Patients Allows Early Diagnosis And Successful Treatment Of Lymphedema
A recent study shows that pre-operative assessments of breast cancer patients by physical therapists allow for early diagnosis and successful treatment of lymphedema.
The study, conducted by the National Naval Medical Center (NNMC) and the National Institutes of Health (NIH) and in collaboration with the University of Michigan-Flint and George Mason University, was published in the journal, Cancer (April 25, 2008). The authors demonstrated the effectiveness of a surveillance program that included pre-operative limb volume measurement and interval post-operative follow-up to successfully detect and treat lymphedema, a chronic and often irreversible condition that can cause significant swelling of the upper and lower extremities due to the build-up of excess lymph fluid.
"This study is significant for several reasons, but none more so than it showing that detection and management of lymphedema at early stages may prevent the condition from progressing to a chronic, disabling stage and may enable a more cost-effective, conservative intervention," said American Physical Therapy Association (APTA) spokesperson and the study's lead author, Nicole L Stout Gergich, PT, MPT, CLT-LANA, of the National Naval Medical Center (NNMC) Breast Care Center, in Bethesda, Maryland.
Breast cancer related lymphedema is associated with decreased arm function, disability and diminished quality of life. If the condition is not diagnosed early and managed, it can progress to a situation where the patient is at risk for infection and further shoulder complications. The swelling is disfiguring and many times prohibits patients from finding clothes that fit properly.
Stout noted that the baseline pre-operative assessment of 196 breast cancer patients participating in the study - which was conducted from 2001 to 2005 - included basic strength, range of motion, limb volume, and physical activity level. "To measure limb volume, we employed infra-red technology that scans the limbs using beams and sensors, providing us with very accurate information," she said. All study participants were monitored one month post-surgery and at three-month intervals thereafter for one year even if they exhibited no swelling. "Using both the pre- and post-operative assessments enabled us to diagnose lymphedema before it became visible, which is an unprecedented accomplishment," Stout noted.
Once lymphedema was diagnosed in 43 of the patients participating in the study, the condition was managed using a conservative compression garment, atypical of lymphedema treatment, observed Stout. A light-grade compression sleeve and gauntlet, fitted by the physical therapist, were prescribed for daily wear. "Lymphedema is normally treated with more aggressive and often costly and time-consuming techniques, such as complete decongestive therapy, which requires the patient to attend daily therapy sessions for weeks and wear bulky compression bandages. This study clearly demonstrates that the condition can be managed with a more conservative treatment option when it is diagnosed at its earliest presentation, which will be good news to breast cancer patients," she added.
"What we hope to garner from publicizing this study is that it will encourage breast cancer patients to ask the questions that need to be asked regarding their treatment, as well as galvanize physicians, surgeons, oncologists and other physical therapists to make early intervention and conservative treatment of lymphedema the standard of care in breast cancer care," Stout concluded.
Physical therapists are health care professionals who diagnose and manage individuals of all ages, from newborns to elders, who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. Physical therapists examine each individual and develop a plan of care using treatment techniques to promote the ability to move, reduce pain, restore function, and prevent disability. Physical therapists also work with individuals to prevent the loss of mobility by developing fitness- and wellness-oriented programs for healthier and more active lifestyles.
The American Physical Therapy Association is a national organization representing physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can visit findapt.us to find a physical therapist in their area, as well as apta/consumer for physical therapy news and information.
American Physical Therapy Association
Buy Ampicillin Without Prescription
The study, conducted by the National Naval Medical Center (NNMC) and the National Institutes of Health (NIH) and in collaboration with the University of Michigan-Flint and George Mason University, was published in the journal, Cancer (April 25, 2008). The authors demonstrated the effectiveness of a surveillance program that included pre-operative limb volume measurement and interval post-operative follow-up to successfully detect and treat lymphedema, a chronic and often irreversible condition that can cause significant swelling of the upper and lower extremities due to the build-up of excess lymph fluid.
"This study is significant for several reasons, but none more so than it showing that detection and management of lymphedema at early stages may prevent the condition from progressing to a chronic, disabling stage and may enable a more cost-effective, conservative intervention," said American Physical Therapy Association (APTA) spokesperson and the study's lead author, Nicole L Stout Gergich, PT, MPT, CLT-LANA, of the National Naval Medical Center (NNMC) Breast Care Center, in Bethesda, Maryland.
Breast cancer related lymphedema is associated with decreased arm function, disability and diminished quality of life. If the condition is not diagnosed early and managed, it can progress to a situation where the patient is at risk for infection and further shoulder complications. The swelling is disfiguring and many times prohibits patients from finding clothes that fit properly.
Stout noted that the baseline pre-operative assessment of 196 breast cancer patients participating in the study - which was conducted from 2001 to 2005 - included basic strength, range of motion, limb volume, and physical activity level. "To measure limb volume, we employed infra-red technology that scans the limbs using beams and sensors, providing us with very accurate information," she said. All study participants were monitored one month post-surgery and at three-month intervals thereafter for one year even if they exhibited no swelling. "Using both the pre- and post-operative assessments enabled us to diagnose lymphedema before it became visible, which is an unprecedented accomplishment," Stout noted.
Once lymphedema was diagnosed in 43 of the patients participating in the study, the condition was managed using a conservative compression garment, atypical of lymphedema treatment, observed Stout. A light-grade compression sleeve and gauntlet, fitted by the physical therapist, were prescribed for daily wear. "Lymphedema is normally treated with more aggressive and often costly and time-consuming techniques, such as complete decongestive therapy, which requires the patient to attend daily therapy sessions for weeks and wear bulky compression bandages. This study clearly demonstrates that the condition can be managed with a more conservative treatment option when it is diagnosed at its earliest presentation, which will be good news to breast cancer patients," she added.
"What we hope to garner from publicizing this study is that it will encourage breast cancer patients to ask the questions that need to be asked regarding their treatment, as well as galvanize physicians, surgeons, oncologists and other physical therapists to make early intervention and conservative treatment of lymphedema the standard of care in breast cancer care," Stout concluded.
Physical therapists are health care professionals who diagnose and manage individuals of all ages, from newborns to elders, who have medical problems or other health-related conditions that limit their abilities to move and perform functional activities in their daily lives. Physical therapists examine each individual and develop a plan of care using treatment techniques to promote the ability to move, reduce pain, restore function, and prevent disability. Physical therapists also work with individuals to prevent the loss of mobility by developing fitness- and wellness-oriented programs for healthier and more active lifestyles.
The American Physical Therapy Association is a national organization representing physical therapists, physical therapist assistants, and students nationwide. Its goal is to foster advancements in physical therapist education, practice, and research. Consumers can visit findapt.us to find a physical therapist in their area, as well as apta/consumer for physical therapy news and information.
American Physical Therapy Association
Buy Ampicillin Without Prescription
Vion Announces Suspension Of Phase III Trial In Relapsed AML
VION
PHARMACEUTICALS, INC. (Nasdaq: VION) announced today that it would suspend
enrollment and further patient treatment in its Phase III clinical study of
Cloretazine(R) (VNP40101M) for patients with relapsed adult myelogenous
leukemia (AML) pending a detailed review of all of the data from the trial.
This decision was based on the recommendation of the trial's independent
Data Safety Monitoring Board (DSMB) after a planned interim analysis.
The Phase III trial is a double-blind placebo-controlled randomized
evaluation of an experimental treatment consisting of Ara-C plus
Cloretazine(R) (VNP40101M) versus a control arm regimen of Ara-C and
placebo. The trial is designed to accrue patients in first relapse AML
whose first complete remission (CR) was more than three months but less
than twenty-four months in duration. Patients are stratified according to:
(i) age, greater than or less than 60 years and (ii) length of the first
CR, more than or less than 12 months in duration. The primary endpoint for
the trial is the objective response rate, defined as CR plus CRp (a
complete remission with incomplete recovery of platelet count). Secondary
endpoints include time to progression, duration of response, overall
survival and toxicity.
The DSMB's review of clinical data from the first 210 treated patients
resulted in a recommendation that enrollment and further treatment of
patients on study be suspended. The DSMB's recommendation was based on
their evaluation that any advantage in complete remission could be
compromised by the observed on-study mortality to date.
The study will remain blinded while a complete medical review is
conducted.
Alan Kessman, Chief Executive Officer, stated, "There will be a
thorough analysis of all the data to date from this trial, and we will base
any decision on the continuation, possible modification or termination of
the study on the available data." He concluded, "We will provide an update
on the status of the analysis as soon more information is available."
The Company is also evaluating Cloretazine(R) (VNP40101M) as a single
agent in a pivotal Phase II trial in elderly patients with de novo
poor-risk AML. This trial is being conducted in over twenty sites in the
U.S. and Europe. Completion of accrual to this trial is expected to occur
in June or July 2007.
Conference Call
Vion will hold a conference call on Wednesday, May 23, 2007, at 10:30
a.m. Eastern Time.
An audio webcast of the call will be accessible at vionpharm.
Those who wish to listen to the conference call on the Web should visit the
Investor Relations section of the Company's website at least 15 minutes
prior to the event broadcast, and follow the instructions provided to
assure that the necessary audio applications are downloaded and installed.
These programs can be obtained at no charge to the user.
Vion Pharmaceuticals, Inc. is committed to extending the lives and
improving the quality of life of cancer patients worldwide by developing
and commercializing innovative cancer therapeutics. Vion has two agents in
clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is
being evaluated in a Phase II pivotal trial as a single agent in elderly
patients with previously untreated de novo poor-risk acute myelogenous
leukemia. An additional trial of Cloretazine(R) (VNP40101M) as a single
agent in small cell lung cancer is also underway. Triapine(R), a potent
inhibitor of a key step in DNA synthesis, is being evaluated in clinical
trials sponsored by the National Cancer Institute. In preclinical studies,
Vion is also evaluating VNP40541, a hypoxia-selective compound, and
hydrazone compounds. The Company also is seeking development partners for
TAPET(R), its modified Salmonella vector used to deliver anticancer agents
directly to tumors. For additional information on Vion and its product
development programs, visit the Company's Internet web site at
vionpharm.
This news release contains forward-looking statements. Such statements
are subject to certain risk factors which may cause Vion's plans to differ
or results to vary from those expected, including Vion's potential
inability to obtain regulatory approval for its products, delayed or
unfavorable results of drug trials, the possibility that favorable results
of earlier preclinical studies or clinical trials are not predictive of
safety and efficacy results in later clinical trials, the need for
additional research and testing, the potential inability to secure external
sources of funding to continue operations, the inability to access capital
and funding on favorable terms, continued operating losses and the
inability to continue operations as a result, and a variety of other risks
set forth from time to time in Vion's filings with the Securities and
Exchange Commission, including but not limited to the risks attendant to
the forward-looking statements included under Item 1A, "Risk Factors" in
Vion's Annual Report on Form 10-K for the year ended December 31, 2006. In
particular, there can be no assurance as to the results of any of the
Company's clinical trials, that any of these trials will continue to full
accrual, or that any of these trials will not be discontinued, modified,
delayed or ceased altogether. Except in special circumstances in which a
duty to update arises under law when prior disclosure becomes materially
misleading in light of subsequent events, Vion does not intend to update
any of these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events.
Vion Pharmaceuticals, Inc.
vionpharm
Buy Quinine Without Prescription
PHARMACEUTICALS, INC. (Nasdaq: VION) announced today that it would suspend
enrollment and further patient treatment in its Phase III clinical study of
Cloretazine(R) (VNP40101M) for patients with relapsed adult myelogenous
leukemia (AML) pending a detailed review of all of the data from the trial.
This decision was based on the recommendation of the trial's independent
Data Safety Monitoring Board (DSMB) after a planned interim analysis.
The Phase III trial is a double-blind placebo-controlled randomized
evaluation of an experimental treatment consisting of Ara-C plus
Cloretazine(R) (VNP40101M) versus a control arm regimen of Ara-C and
placebo. The trial is designed to accrue patients in first relapse AML
whose first complete remission (CR) was more than three months but less
than twenty-four months in duration. Patients are stratified according to:
(i) age, greater than or less than 60 years and (ii) length of the first
CR, more than or less than 12 months in duration. The primary endpoint for
the trial is the objective response rate, defined as CR plus CRp (a
complete remission with incomplete recovery of platelet count). Secondary
endpoints include time to progression, duration of response, overall
survival and toxicity.
The DSMB's review of clinical data from the first 210 treated patients
resulted in a recommendation that enrollment and further treatment of
patients on study be suspended. The DSMB's recommendation was based on
their evaluation that any advantage in complete remission could be
compromised by the observed on-study mortality to date.
The study will remain blinded while a complete medical review is
conducted.
Alan Kessman, Chief Executive Officer, stated, "There will be a
thorough analysis of all the data to date from this trial, and we will base
any decision on the continuation, possible modification or termination of
the study on the available data." He concluded, "We will provide an update
on the status of the analysis as soon more information is available."
The Company is also evaluating Cloretazine(R) (VNP40101M) as a single
agent in a pivotal Phase II trial in elderly patients with de novo
poor-risk AML. This trial is being conducted in over twenty sites in the
U.S. and Europe. Completion of accrual to this trial is expected to occur
in June or July 2007.
Conference Call
Vion will hold a conference call on Wednesday, May 23, 2007, at 10:30
a.m. Eastern Time.
An audio webcast of the call will be accessible at vionpharm.
Those who wish to listen to the conference call on the Web should visit the
Investor Relations section of the Company's website at least 15 minutes
prior to the event broadcast, and follow the instructions provided to
assure that the necessary audio applications are downloaded and installed.
These programs can be obtained at no charge to the user.
Vion Pharmaceuticals, Inc. is committed to extending the lives and
improving the quality of life of cancer patients worldwide by developing
and commercializing innovative cancer therapeutics. Vion has two agents in
clinical trials. Cloretazine(R) (VNP40101M), a unique alkylating agent, is
being evaluated in a Phase II pivotal trial as a single agent in elderly
patients with previously untreated de novo poor-risk acute myelogenous
leukemia. An additional trial of Cloretazine(R) (VNP40101M) as a single
agent in small cell lung cancer is also underway. Triapine(R), a potent
inhibitor of a key step in DNA synthesis, is being evaluated in clinical
trials sponsored by the National Cancer Institute. In preclinical studies,
Vion is also evaluating VNP40541, a hypoxia-selective compound, and
hydrazone compounds. The Company also is seeking development partners for
TAPET(R), its modified Salmonella vector used to deliver anticancer agents
directly to tumors. For additional information on Vion and its product
development programs, visit the Company's Internet web site at
vionpharm.
This news release contains forward-looking statements. Such statements
are subject to certain risk factors which may cause Vion's plans to differ
or results to vary from those expected, including Vion's potential
inability to obtain regulatory approval for its products, delayed or
unfavorable results of drug trials, the possibility that favorable results
of earlier preclinical studies or clinical trials are not predictive of
safety and efficacy results in later clinical trials, the need for
additional research and testing, the potential inability to secure external
sources of funding to continue operations, the inability to access capital
and funding on favorable terms, continued operating losses and the
inability to continue operations as a result, and a variety of other risks
set forth from time to time in Vion's filings with the Securities and
Exchange Commission, including but not limited to the risks attendant to
the forward-looking statements included under Item 1A, "Risk Factors" in
Vion's Annual Report on Form 10-K for the year ended December 31, 2006. In
particular, there can be no assurance as to the results of any of the
Company's clinical trials, that any of these trials will continue to full
accrual, or that any of these trials will not be discontinued, modified,
delayed or ceased altogether. Except in special circumstances in which a
duty to update arises under law when prior disclosure becomes materially
misleading in light of subsequent events, Vion does not intend to update
any of these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events.
Vion Pharmaceuticals, Inc.
vionpharm
Buy Quinine Without Prescription
Phase 2 Data Demonstrate Perifosine's Promising Efficacy In The Treatment Of Advanced Leukemia, Lymphoma And Multiple Myeloma
Aeterna Zentaris Inc. (NASDAQ: AEZS,TSX: AEZ) announced Phase 2 data presented for the first time on perifosine, its lead novel oral anti-cancer compound, showing promising clinical activity, safety and tolerability in patients with advanced chronic lymphocytic leukemia (CLL) and Hodgkin's lymphoma (HL). The data were presented over the weekend at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida.
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "The encouraging data in advanced leukemia and Hodgkin's lymphoma presented at the ASH meeting, confirm perifosine's efficacy and safety as a novel, oral anti-cancer agent not only in combination therapy with approved anti-cancer agents but also as a single agent therapeutic. Data also showcase perifosine's potential beyond the current Phase 3 registration trials in metastatic colorectal cancer and multiple myeloma."
Key highlights from the two Phase 2 poster presentations are as follows:
Abstract # 2861: "Clinical Activity and Safety of the Combined Therapy with the AKT Inhibitor Perifosine and the Multikinase Inhibitor Sorafenib In Heavily Pretreated Patients with Relapsed/Refractory Lymphomas: Preliminary Results of a Phase II Trial"
Study Background
In this Phase 2 study, 26 patients were enrolled with advanced lymphoma (6 NHL, 4 CLL, 1 Waldenstrom's Macroglobulinemia and 15 Hodgkin's lymphoma). 73% of patients were previously refractory to their prior therapy, with 85% of patients having had 4 or more prior therapies. Perifosine (50 mg BID) was started as a single agent for 28 days; after 28 days, patients achieving partial response (PR) or better were continued on single agent perifosine. Patients achieving less than a PR were given the combination of perifosine (50 mg BID) plus sorafenib (Nexavar®) at 400 mg BID.
Results
All of the 4 CLL patients in the study achieved a partial response on single-agent perifosine within one month of treatment and remained on perifosine single agent. Response durations for each of the 4 patients were 4, 8, 9+ and 12 months. The remaining 22 patients were administered the combination with sorafenib, where 5 of the 15 (33%) Hodgkin's lymphoma patients achieved a partial response with a median response duration of 9 months. An additional 6 patients receiving the combination (40%) achieved stable disease. The combination was well tolerated with no unexpected safety events.
The investigators concluded that perifosine in combination with sorafenib has significant anti-lymphoma activity in relapsed/refractory HL, and that perifosine as a single agent induced prolonged responses in high-risk, heavily pretreated CLL patients.
Abstract # 1842: "Pre-Clinical and Interim Results of a Phase II Trial of Perifosine In Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)"
Study Background:
In this Phase 2 study, 12 patients with advanced CLL began treatment with single agent perifosine at 50 mg BID. Patients on study were heavily pre-treated having had a median of 4 prior lines of therapy with 75% of patients classified as Rai stage IV.
Results
1 patient achieved a partial response (5 months on treatment) and 5 additional patients achieved stable disease (median duration of 4.25 months), for an overall 50% clinical benefit rate (PR + SD). Perifosine was well tolerated with minimal dose modifications.
Abstract # 3064: "Final Phase I Results of Perifosine In Combination with Lenalidomide and Dexamethasone In Patients with Relapsed or Refractory Multiple Myeloma (MM)"
Additionally, the final data set from the Phase 1 study of perifosine + lenalidomide (Revlimid®) + dexamethasone were also presented during the ASH meeting. The final data showed a 73% objective response rate (minimal response or better) with a 50% PR or better, a median Progression-Free Survival of 10.8 months, and a median duration for Overall Survival of 30.6 months. The myeloma investigators concluded that perifosine in combination with lenalidomide + dexamethasone was well tolerated even at the highest doses used, and demonstrated encouraging clinical activity and survival.
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The product works by interfering with membranes of cancer cells thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival. Perifosine, in combination with chemotherapeutic agents, is currently being studied for the treatment of multiple myeloma, colorectal cancer and other cancers, and is the most advanced anticancer compound of its class in late-stage development. Perifosine as monotherapy, is being explored in other indications. The US Food & Drug Administration ("FDA") has granted perifosine orphan-drug designation in multiple myeloma and neuroblastoma, and Fast Track designations in both multiple myeloma and refractory advanced colorectal cancer. Additionally, an agreement was reached with the FDA to conduct the Phase 3 trials in both of these indications under a Special Protocol Assessment. Perifosine has also been granted orphan medicinal product designation from the European Medicines Agency ("EMA") in multiple myeloma. Furthermore, perifosine has received positive Scientific Advice from the EMA for both the multiple myeloma and advanced colorectal cancer programs, with ongoing Phase 3 trials for these indications expected to be sufficient for registration in Europe. Perifosine rights have been licensed to Keryx Biopharmaceuticals for North America and to Handok for Korea.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
Source: AETERNA ZENTARIS INC
View drug information on Nexavar; Revlimid.
Buy Clindamycin Gel Without Prescription
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "The encouraging data in advanced leukemia and Hodgkin's lymphoma presented at the ASH meeting, confirm perifosine's efficacy and safety as a novel, oral anti-cancer agent not only in combination therapy with approved anti-cancer agents but also as a single agent therapeutic. Data also showcase perifosine's potential beyond the current Phase 3 registration trials in metastatic colorectal cancer and multiple myeloma."
Key highlights from the two Phase 2 poster presentations are as follows:
Abstract # 2861: "Clinical Activity and Safety of the Combined Therapy with the AKT Inhibitor Perifosine and the Multikinase Inhibitor Sorafenib In Heavily Pretreated Patients with Relapsed/Refractory Lymphomas: Preliminary Results of a Phase II Trial"
Study Background
In this Phase 2 study, 26 patients were enrolled with advanced lymphoma (6 NHL, 4 CLL, 1 Waldenstrom's Macroglobulinemia and 15 Hodgkin's lymphoma). 73% of patients were previously refractory to their prior therapy, with 85% of patients having had 4 or more prior therapies. Perifosine (50 mg BID) was started as a single agent for 28 days; after 28 days, patients achieving partial response (PR) or better were continued on single agent perifosine. Patients achieving less than a PR were given the combination of perifosine (50 mg BID) plus sorafenib (Nexavar®) at 400 mg BID.
Results
All of the 4 CLL patients in the study achieved a partial response on single-agent perifosine within one month of treatment and remained on perifosine single agent. Response durations for each of the 4 patients were 4, 8, 9+ and 12 months. The remaining 22 patients were administered the combination with sorafenib, where 5 of the 15 (33%) Hodgkin's lymphoma patients achieved a partial response with a median response duration of 9 months. An additional 6 patients receiving the combination (40%) achieved stable disease. The combination was well tolerated with no unexpected safety events.
The investigators concluded that perifosine in combination with sorafenib has significant anti-lymphoma activity in relapsed/refractory HL, and that perifosine as a single agent induced prolonged responses in high-risk, heavily pretreated CLL patients.
Abstract # 1842: "Pre-Clinical and Interim Results of a Phase II Trial of Perifosine In Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)"
Study Background:
In this Phase 2 study, 12 patients with advanced CLL began treatment with single agent perifosine at 50 mg BID. Patients on study were heavily pre-treated having had a median of 4 prior lines of therapy with 75% of patients classified as Rai stage IV.
Results
1 patient achieved a partial response (5 months on treatment) and 5 additional patients achieved stable disease (median duration of 4.25 months), for an overall 50% clinical benefit rate (PR + SD). Perifosine was well tolerated with minimal dose modifications.
Abstract # 3064: "Final Phase I Results of Perifosine In Combination with Lenalidomide and Dexamethasone In Patients with Relapsed or Refractory Multiple Myeloma (MM)"
Additionally, the final data set from the Phase 1 study of perifosine + lenalidomide (Revlimid®) + dexamethasone were also presented during the ASH meeting. The final data showed a 73% objective response rate (minimal response or better) with a 50% PR or better, a median Progression-Free Survival of 10.8 months, and a median duration for Overall Survival of 30.6 months. The myeloma investigators concluded that perifosine in combination with lenalidomide + dexamethasone was well tolerated even at the highest doses used, and demonstrated encouraging clinical activity and survival.
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The product works by interfering with membranes of cancer cells thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival. Perifosine, in combination with chemotherapeutic agents, is currently being studied for the treatment of multiple myeloma, colorectal cancer and other cancers, and is the most advanced anticancer compound of its class in late-stage development. Perifosine as monotherapy, is being explored in other indications. The US Food & Drug Administration ("FDA") has granted perifosine orphan-drug designation in multiple myeloma and neuroblastoma, and Fast Track designations in both multiple myeloma and refractory advanced colorectal cancer. Additionally, an agreement was reached with the FDA to conduct the Phase 3 trials in both of these indications under a Special Protocol Assessment. Perifosine has also been granted orphan medicinal product designation from the European Medicines Agency ("EMA") in multiple myeloma. Furthermore, perifosine has received positive Scientific Advice from the EMA for both the multiple myeloma and advanced colorectal cancer programs, with ongoing Phase 3 trials for these indications expected to be sufficient for registration in Europe. Perifosine rights have been licensed to Keryx Biopharmaceuticals for North America and to Handok for Korea.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
Source: AETERNA ZENTARIS INC
View drug information on Nexavar; Revlimid.
Buy Clindamycin Gel Without Prescription
A Diagnostic Marker In Hepatocellular Carcinoma
E2F5 is a member of the E2F transcription factor family, and plays a key role in cell growth and proliferation. Overexpression of E2F5 has been reported in various human cancers, but not in liver cancer, and its biological implication is largely unknown. It is not known whether E2F5 plays a tumor suppressor role or an oncogenic role. Furthermore, there has been no report on the expression profile of E2F5 in HCC and its biological implications on hepatocarcinogenesis.
A research article published on January 28, 2011 in the World Journal of Gastroenterology addresses this question. In this study, the authors investigated the expression profile of E2F5 in primary HCCs and explored the biological effects of E2F5 overexpression by knockdown of the gene.
This is the first evidence that E2F5 is commonly overexpressed in primary human HCC and that E2F5 knockdown profoundly repressed the growth of HCC cells. The overexpression of E2F5 may induce uncontrollable cell cycle progression in liver cells and eventually contribute to cancer transformation by working together with other carcinogenic factors. This study will help to understand hepatocarcinogenesis mechanisms and to define therapeutic targets of early HCC.
Reference:
Jiang Y, Yim SH, Xu HD, Jung SH, Yang SY, Hu HJ, Jung CK, Chung YJ. A potential oncogenic role of the commonly observed E2F5 overexpression in hepatocellular carcinoma. World J Gastroenterol 2011; 17(4): 470-477
Source:
Ye-Ru Wang
World Journal of Gastroenterology
Buy Epivir Without Prescription
A research article published on January 28, 2011 in the World Journal of Gastroenterology addresses this question. In this study, the authors investigated the expression profile of E2F5 in primary HCCs and explored the biological effects of E2F5 overexpression by knockdown of the gene.
This is the first evidence that E2F5 is commonly overexpressed in primary human HCC and that E2F5 knockdown profoundly repressed the growth of HCC cells. The overexpression of E2F5 may induce uncontrollable cell cycle progression in liver cells and eventually contribute to cancer transformation by working together with other carcinogenic factors. This study will help to understand hepatocarcinogenesis mechanisms and to define therapeutic targets of early HCC.
Reference:
Jiang Y, Yim SH, Xu HD, Jung SH, Yang SY, Hu HJ, Jung CK, Chung YJ. A potential oncogenic role of the commonly observed E2F5 overexpression in hepatocellular carcinoma. World J Gastroenterol 2011; 17(4): 470-477
Source:
Ye-Ru Wang
World Journal of Gastroenterology
Buy Epivir Without Prescription
New Octapharma 10% High Purity Immunoglobulin Enters Phase II/III Study In Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Octapharma AG announced the imminent start of the biggest ever study of an intravenous immunoglobulin preparation (IVIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
The double-blind, placebo-controlled, randomised, multicentre, adaptive, two-stage Phase 2/3 dose-finding study will investigate the efficacy and safety of Octapharma's novel 10% intravenous immunoglobulin in the treatment of CIDP and, together with results from additional on-going and upcoming studies, will support its regulatory filing in Europe and the US.
Commenting on the start of the study, Kim Björnstrup, Vice Chairman of Octapharma Group said, "The development of our novel 10% IVIG is part of our ongoing commitment to invest in the development of protein based immunotherapies and in particular in IgG preparations. For 25 years, our cutting-edge research program has sought to develop new biological entities tailored specifically around the needs of clinicians and patients - delivering improved quality of life for patients and ease of delivery and management for hospitals."
"Octapharma's stated aim is not to develop just another IVIG brand but to invest extensive time and preclinical resources to ensure that the new IVIG will offer outstanding features, representing tangible added value for the patient and care giver, such as exceptional tolerability," added Kim Björnstrup.
The development of this completely new high purity IVIG builds upon Octapharma's experience in the area of immunoglobulin products. Octapharma's current leading IVIG brand has been introduced to the market in 1995 and is currently registered in about 60 countries, including the EU and the US.
"Octapharma's new 10% IVIG will be a step forward in the evolution of IVIG products. Regarding the development of the product, Octapharma has looked to optimise the characteristics of the product for improved patient outcomes, such as high tolerability even at high infusion rates. Pre-clinical studies and data from an on-going clinical trial in primary immunodeficiency (PI) have confirmed that a favourable tolerability profile may be expected" commented Dr Stefan Haag, Head of Octapharma's International Immunotherapy Business Unit.
The Phase II/III study in CIDP represents another element in a series of studies to investigate Octapharma's new 10% IVIG for a range of neurologic and haematological conditions including immune thrombocytopenic purpura (ITP), Guillain-BarrГ© syndrome (GBS), Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
About Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
CIDP is a distinct acquired chronic progressive or relapsing and spontaneously remitting
neurological condition characterised by the slow onset of weakness, areflexia and impaired sensation, which progressively increases1. It is reported that 4% to 17% of CIDP patients die from the disease usually as a consequence of respiratory failure or pulmonary embolism, about 50% require persistent treatment, and 13% are permanently disabled2. CIDP is generally considered to be an autoimmune disease caused by the activation of autoimmune mechanisms resulting from exposure to environmental antigens. These antigens may trigger immune responses that cross react with antigens in the myelin sheath of peripheral nerves3. Over the last 20 years, high-dose IVIG has become an effective and safe therapeutic option for CIDP. Because of the ease of its application, IVIG has become the preferred treatment for children with CIDP4,5. A recently published placebo-controlled study on CIDP patients confirmed this short term benefit and showed sustained benefit from repeated IVIG treatment6.
References
(1) Hughes RA, Allen D, Makowska A, Gregson NA. Pathogenesis of chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst 2006; Mar;11(1):30-46.
(2) Hughes RA. Management of chronic inflammatory demyelinating polyradiculoneuropathy. Drugs 2003;63(3):275-87.
(3) Hughes RA, Hadden RD, Gregson NA, Smith KJ. Pathogenesis of Guillain-Barre syndrome. J Neuroimmunol 1999 Dec;100(1-2):74-97.
(4) Simmons Z, Wald JJ, Albers JW. Chronic inflammatory demyelinating polyradiculoneuropathy in children: II. Long-term follow-up, with comparison to adults. Muscle Nerve 1997 Dec;20(12):1569-75.
(5) Simmons Z, Wald JJ, Albers JW. Chronic inflammatory demyelinating polyradiculoneuropathy in children: I. Presentation, electrodiagnostic studies, and initial clinical course, with comparison to adults. Muscle Nerve 1997 Aug;20(8):1008-15.
(6) Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, et al. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol 2008 Jan 4;7(2):136-44.
Source:
Octapharma AG
Buy Fosamax Without Prescription
The double-blind, placebo-controlled, randomised, multicentre, adaptive, two-stage Phase 2/3 dose-finding study will investigate the efficacy and safety of Octapharma's novel 10% intravenous immunoglobulin in the treatment of CIDP and, together with results from additional on-going and upcoming studies, will support its regulatory filing in Europe and the US.
Commenting on the start of the study, Kim Björnstrup, Vice Chairman of Octapharma Group said, "The development of our novel 10% IVIG is part of our ongoing commitment to invest in the development of protein based immunotherapies and in particular in IgG preparations. For 25 years, our cutting-edge research program has sought to develop new biological entities tailored specifically around the needs of clinicians and patients - delivering improved quality of life for patients and ease of delivery and management for hospitals."
"Octapharma's stated aim is not to develop just another IVIG brand but to invest extensive time and preclinical resources to ensure that the new IVIG will offer outstanding features, representing tangible added value for the patient and care giver, such as exceptional tolerability," added Kim Björnstrup.
The development of this completely new high purity IVIG builds upon Octapharma's experience in the area of immunoglobulin products. Octapharma's current leading IVIG brand has been introduced to the market in 1995 and is currently registered in about 60 countries, including the EU and the US.
"Octapharma's new 10% IVIG will be a step forward in the evolution of IVIG products. Regarding the development of the product, Octapharma has looked to optimise the characteristics of the product for improved patient outcomes, such as high tolerability even at high infusion rates. Pre-clinical studies and data from an on-going clinical trial in primary immunodeficiency (PI) have confirmed that a favourable tolerability profile may be expected" commented Dr Stefan Haag, Head of Octapharma's International Immunotherapy Business Unit.
The Phase II/III study in CIDP represents another element in a series of studies to investigate Octapharma's new 10% IVIG for a range of neurologic and haematological conditions including immune thrombocytopenic purpura (ITP), Guillain-BarrГ© syndrome (GBS), Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
About Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
CIDP is a distinct acquired chronic progressive or relapsing and spontaneously remitting
neurological condition characterised by the slow onset of weakness, areflexia and impaired sensation, which progressively increases1. It is reported that 4% to 17% of CIDP patients die from the disease usually as a consequence of respiratory failure or pulmonary embolism, about 50% require persistent treatment, and 13% are permanently disabled2. CIDP is generally considered to be an autoimmune disease caused by the activation of autoimmune mechanisms resulting from exposure to environmental antigens. These antigens may trigger immune responses that cross react with antigens in the myelin sheath of peripheral nerves3. Over the last 20 years, high-dose IVIG has become an effective and safe therapeutic option for CIDP. Because of the ease of its application, IVIG has become the preferred treatment for children with CIDP4,5. A recently published placebo-controlled study on CIDP patients confirmed this short term benefit and showed sustained benefit from repeated IVIG treatment6.
References
(1) Hughes RA, Allen D, Makowska A, Gregson NA. Pathogenesis of chronic inflammatory demyelinating polyradiculoneuropathy. J Peripher Nerv Syst 2006; Mar;11(1):30-46.
(2) Hughes RA. Management of chronic inflammatory demyelinating polyradiculoneuropathy. Drugs 2003;63(3):275-87.
(3) Hughes RA, Hadden RD, Gregson NA, Smith KJ. Pathogenesis of Guillain-Barre syndrome. J Neuroimmunol 1999 Dec;100(1-2):74-97.
(4) Simmons Z, Wald JJ, Albers JW. Chronic inflammatory demyelinating polyradiculoneuropathy in children: II. Long-term follow-up, with comparison to adults. Muscle Nerve 1997 Dec;20(12):1569-75.
(5) Simmons Z, Wald JJ, Albers JW. Chronic inflammatory demyelinating polyradiculoneuropathy in children: I. Presentation, electrodiagnostic studies, and initial clinical course, with comparison to adults. Muscle Nerve 1997 Aug;20(8):1008-15.
(6) Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, et al. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol 2008 Jan 4;7(2):136-44.
Source:
Octapharma AG
Buy Fosamax Without Prescription
USA Today Editorial Addresses IOM Report, Wal-Mart, Medicare Prescription Drug Benefit
A USA Today editorial on Wednesday addresses FDA, Wal-Mart and the doughnut hole in the Medicare prescription drug benefit. Summaries of comments appear below.
FDA: According to USA Today, a "troubling" recent Institute of Medicine report finds that FDA "remains plagued by bureaucratic infighting, poor management and a dangerous passivity in evaluating drug safety." FDA maintains that approved drugs are "safe and effective," but the side effects of some medications are not "known until years later, when millions use them and adverse effects show up," the editorial states. "Rather than aggressively monitoring these problems, FDA waits for reports from doctors to trickle in," according to the editorial. FDA says Congress needs to increase funding and authority for the agency so it can require drug makers to conduct follow-up safety studies, but "[h]ow many more reports will collect dust on a shelf before FDA and Congress act?" the editorial asks.
Wal-Mart: "Unlike FDA," the editorial states, "Wal-Mart ... moves quickly to confound its critics and meet needs of customers." Wal-Mart has announced that next year it plans to offer 150 generic drugs at $4 for a 30-day supply in its pharmacies nationwide. According to the editorial, "Wal-Mart isn't being charitable. Even at $4, it expects to make money on generics and hopes to attract customers to buy other products." The editorial notes that the company's "size gives it the clout to create big changes in the marketplace," adding, "Stiff competition, coupled with tough negotiations with vendors to squeeze costs out of the system, are the best ways to hold down the cost of prescription drugs."
Doughnut hole: "Six weeks from the congressional elections, some Democrats are trying to make political hay of the fact that" more than three million U.S. residents could reach a gap in Medicare coverage known as the doughnut hole, the editorial states. Some Democrats have proposed "revamping" the Medicare program to fill the coverage gap, which "would be about as wise as eating a dozen Krispy Kremes," according to the editorial. Eliminating the coverage gap "could add hundreds of billions of dollars over 10 years to the program's already unaffordable costs," the editorial states, concluding, "Plans to fill the doughnut hole might sound tasty on the campaign trail but would worsen the nation's fiscal indigestion" (USA Today, 9/27).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Buy Ventolin Online no Prescription
FDA: According to USA Today, a "troubling" recent Institute of Medicine report finds that FDA "remains plagued by bureaucratic infighting, poor management and a dangerous passivity in evaluating drug safety." FDA maintains that approved drugs are "safe and effective," but the side effects of some medications are not "known until years later, when millions use them and adverse effects show up," the editorial states. "Rather than aggressively monitoring these problems, FDA waits for reports from doctors to trickle in," according to the editorial. FDA says Congress needs to increase funding and authority for the agency so it can require drug makers to conduct follow-up safety studies, but "[h]ow many more reports will collect dust on a shelf before FDA and Congress act?" the editorial asks.
Wal-Mart: "Unlike FDA," the editorial states, "Wal-Mart ... moves quickly to confound its critics and meet needs of customers." Wal-Mart has announced that next year it plans to offer 150 generic drugs at $4 for a 30-day supply in its pharmacies nationwide. According to the editorial, "Wal-Mart isn't being charitable. Even at $4, it expects to make money on generics and hopes to attract customers to buy other products." The editorial notes that the company's "size gives it the clout to create big changes in the marketplace," adding, "Stiff competition, coupled with tough negotiations with vendors to squeeze costs out of the system, are the best ways to hold down the cost of prescription drugs."
Doughnut hole: "Six weeks from the congressional elections, some Democrats are trying to make political hay of the fact that" more than three million U.S. residents could reach a gap in Medicare coverage known as the doughnut hole, the editorial states. Some Democrats have proposed "revamping" the Medicare program to fill the coverage gap, which "would be about as wise as eating a dozen Krispy Kremes," according to the editorial. Eliminating the coverage gap "could add hundreds of billions of dollars over 10 years to the program's already unaffordable costs," the editorial states, concluding, "Plans to fill the doughnut hole might sound tasty on the campaign trail but would worsen the nation's fiscal indigestion" (USA Today, 9/27).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Buy Ventolin Online no Prescription
GE Foundation Grants $1 Million To Health Centers In Milwaukee
GE Foundation-the philanthropic organization of GE- and the GE Corporate Diversity Council today announced the award of $1 million in total to four Milwaukee community healthcare centers toward the goal of increasing access to primary care for uninsured and underserved populations across the city.
The donations expand the reach of the GE Developing Health program, a 3-year, $25 million commitment that provides grant funding and GE employee engagement to selected healthcare centers across the United States.
"With nearly 16% of the U.S. population without health insurance, GE recognizes there is a critical need in the U.S. healthcare system and the Developing Health program seeks to fill the gap in access to quality care for underserved communities," said Bob Corcoran, president of the GE Foundation. "Our partnership with these Milwaukee health centers is a great example of the positive impact that can be made by combining funding with GE's volunteer support."
The four Milwaukee medical centers are:
- the MLK Heritage Health Center;
- the Isaac Coggs Heritage Health Center;
- the Chavez Health Center; and
- the Parkway Health Center.
Each of the four health centers will receive $250,000, in two installments over two years. Milwaukee is the second city to receive grants through the GE Foundation's Developing Health initiative after New York City. The program will eventually extend to 10 cities across the United States.
"I've lived in Milwaukee all my life and understand well the area's potential, and its challenges, particularly in the area of healthcare. By partnering with these clinics to increase access to primary care we can help more people get the care they need when they need it," said Mike Barber, VP, GE healthymagination. "This program and the volunteers supporting it are a living example of GE's healthymagination strategy to help change the world's approach to healthcare by touching more lives and improving quality of care."
"I am proud of the progress we have made in my years as Governor to make Wisconsin America's healthcare leader," said Wisconsin Governor Jim Doyle. "In Wisconsin, we now have the second-highest percentage of our people with health insurance, we rank first in the nation in healthcare quality, and every child in the state has access to health insurance. Today's commitment by GE will help ensure that we can provide basic, preventative care to thousands more people in Milwaukee who so badly need healthcare."
In addition to the grants themselves, the program announced today includes volunteering from area GE employees drawing on their business management skills. Complementing the financial donation, this unique approach ensures that the health centers also benefit from GE's core competencies including process improvement and business management based on the needs of clinic.
"All of us are honored to be recognized by GE for this funding and the supporting volunteers, which will allow us to increase access and improve our services for the more 30,000 patients and almost 115,000 visits we have annually," said C.C. Henderson, president and CEO, Milwaukee Health Services, Inc. "The MLK Heritage Health Center and the Isaac Coggs Heritage Health Center offer a comprehensive range of services aimed at removing barriers, reducing disparities, and improving health and the quality of life in the community."
"So many people are struggling to maintain their health in our community. The number of people that we see without insurance or resources to pay for health care continues to grow on a daily basis," said John Bartkowski, president and CEO, Sixteenth Street Community Health Center. "GE's generous donation will help support our Chavez and Parkway Health Centers' commitment to provide care regardless of a person's ability to pay; and help many in our area access quality health care and support services."
Developing Health is modeled after GE's successful philanthropic program Developing Health Globally (DHG). It is a partnership between GE Corporate Citizenship and GE Corporate Diversity Council teams that designed and launched the program in October 2009.
"GE recognizes that a diverse, healthy workforce and community is critical for a company to thrive in today's competitive environment," said Deborah Elam, VP and Chief Diversity Officer, GE. "Through Developing Health, GE's Diversity Council aims to help underserved communities of all cultures across the US gain access to quality primary healthcare."
Under the program guidelines, the GE Foundation will provide grants to the selected health centers. Grant recipients were selected based on criteria that include, but are not limited to, need, community impact, leadership, and willingness to partner with GE volunteers, transparency and accountability. The GE Foundation will not accept unsolicited requests for support.
For more information on Developing Health Globally, visit here.
For more information on Developing Health visit here.
Source
GE Foundation
Buy Lumigan Online no Prescription
The donations expand the reach of the GE Developing Health program, a 3-year, $25 million commitment that provides grant funding and GE employee engagement to selected healthcare centers across the United States.
"With nearly 16% of the U.S. population without health insurance, GE recognizes there is a critical need in the U.S. healthcare system and the Developing Health program seeks to fill the gap in access to quality care for underserved communities," said Bob Corcoran, president of the GE Foundation. "Our partnership with these Milwaukee health centers is a great example of the positive impact that can be made by combining funding with GE's volunteer support."
The four Milwaukee medical centers are:
- the MLK Heritage Health Center;
- the Isaac Coggs Heritage Health Center;
- the Chavez Health Center; and
- the Parkway Health Center.
Each of the four health centers will receive $250,000, in two installments over two years. Milwaukee is the second city to receive grants through the GE Foundation's Developing Health initiative after New York City. The program will eventually extend to 10 cities across the United States.
"I've lived in Milwaukee all my life and understand well the area's potential, and its challenges, particularly in the area of healthcare. By partnering with these clinics to increase access to primary care we can help more people get the care they need when they need it," said Mike Barber, VP, GE healthymagination. "This program and the volunteers supporting it are a living example of GE's healthymagination strategy to help change the world's approach to healthcare by touching more lives and improving quality of care."
"I am proud of the progress we have made in my years as Governor to make Wisconsin America's healthcare leader," said Wisconsin Governor Jim Doyle. "In Wisconsin, we now have the second-highest percentage of our people with health insurance, we rank first in the nation in healthcare quality, and every child in the state has access to health insurance. Today's commitment by GE will help ensure that we can provide basic, preventative care to thousands more people in Milwaukee who so badly need healthcare."
In addition to the grants themselves, the program announced today includes volunteering from area GE employees drawing on their business management skills. Complementing the financial donation, this unique approach ensures that the health centers also benefit from GE's core competencies including process improvement and business management based on the needs of clinic.
"All of us are honored to be recognized by GE for this funding and the supporting volunteers, which will allow us to increase access and improve our services for the more 30,000 patients and almost 115,000 visits we have annually," said C.C. Henderson, president and CEO, Milwaukee Health Services, Inc. "The MLK Heritage Health Center and the Isaac Coggs Heritage Health Center offer a comprehensive range of services aimed at removing barriers, reducing disparities, and improving health and the quality of life in the community."
"So many people are struggling to maintain their health in our community. The number of people that we see without insurance or resources to pay for health care continues to grow on a daily basis," said John Bartkowski, president and CEO, Sixteenth Street Community Health Center. "GE's generous donation will help support our Chavez and Parkway Health Centers' commitment to provide care regardless of a person's ability to pay; and help many in our area access quality health care and support services."
Developing Health is modeled after GE's successful philanthropic program Developing Health Globally (DHG). It is a partnership between GE Corporate Citizenship and GE Corporate Diversity Council teams that designed and launched the program in October 2009.
"GE recognizes that a diverse, healthy workforce and community is critical for a company to thrive in today's competitive environment," said Deborah Elam, VP and Chief Diversity Officer, GE. "Through Developing Health, GE's Diversity Council aims to help underserved communities of all cultures across the US gain access to quality primary healthcare."
Under the program guidelines, the GE Foundation will provide grants to the selected health centers. Grant recipients were selected based on criteria that include, but are not limited to, need, community impact, leadership, and willingness to partner with GE volunteers, transparency and accountability. The GE Foundation will not accept unsolicited requests for support.
For more information on Developing Health Globally, visit here.
For more information on Developing Health visit here.
Source
GE Foundation
Buy Lumigan Online no Prescription
IT Equipment Can Harbor Hospital Infections
Although hospital computer equipment can act as a reservoir for pathogenic organisms, including MRSA, researchers writing in the open access journal BMC Infectious Diseases found that bacterial contamination rates from computer equipment were low, possibly as the result of good hand hygiene.
Yen-hsu Chen, from Kaohsiung Medical University Hospital, Taiwan, led a team of researchers who studied IT equipment in a 1600-bed medical center in southern Taiwan with 47 wards and 282 computers. He said, "Most hospital computer devices are not waterproof, or otherwise designed for disinfection needs. Clinically, A. baumannii, P. aeruginosa, and MRSA cause the most common nosocomial infections, and their presence correlates with environmental surface contamination. We screened 282 computer stations, looking for these bacteria and other, less dangerous, species".
The results revealed a 17.4% (49/282) contamination rate of S. aureus, Acinetobacter spp. or Pseudomonas spp. The contamination rates of MRSA and A. baumannii in the ward computers were 1.1% and 4.3%, respectively. No P. aeruginosa was found. According to Chen, "No clinical correlation of contamination of these computer devices to clinical isolates was found. Routine disinfection and even surveillance of these computer devices may not be mandatory in non-outbreak settings".
Notes:
Methicillin-resistant Staphylococcus aureus and Acinetobacter baumannii on computer interface surfaces of hospital wards and association with clinical isolates
Po-Liang Lu, L. k Siu, Tun-Chieh Chen, Ling Ma, Wen-Gin Chiang, Yen-Hsu Chen, Sheng-Fung Lin and Tyen-Po Chen
BMC Infectious Diseases (in press)
biomedcentral/bmcinfectdis/
Source:
Graeme Baldwin
BioMed Central
Buy Erythromycin Without Prescription
Yen-hsu Chen, from Kaohsiung Medical University Hospital, Taiwan, led a team of researchers who studied IT equipment in a 1600-bed medical center in southern Taiwan with 47 wards and 282 computers. He said, "Most hospital computer devices are not waterproof, or otherwise designed for disinfection needs. Clinically, A. baumannii, P. aeruginosa, and MRSA cause the most common nosocomial infections, and their presence correlates with environmental surface contamination. We screened 282 computer stations, looking for these bacteria and other, less dangerous, species".
The results revealed a 17.4% (49/282) contamination rate of S. aureus, Acinetobacter spp. or Pseudomonas spp. The contamination rates of MRSA and A. baumannii in the ward computers were 1.1% and 4.3%, respectively. No P. aeruginosa was found. According to Chen, "No clinical correlation of contamination of these computer devices to clinical isolates was found. Routine disinfection and even surveillance of these computer devices may not be mandatory in non-outbreak settings".
Notes:
Methicillin-resistant Staphylococcus aureus and Acinetobacter baumannii on computer interface surfaces of hospital wards and association with clinical isolates
Po-Liang Lu, L. k Siu, Tun-Chieh Chen, Ling Ma, Wen-Gin Chiang, Yen-Hsu Chen, Sheng-Fung Lin and Tyen-Po Chen
BMC Infectious Diseases (in press)
biomedcentral/bmcinfectdis/
Source:
Graeme Baldwin
BioMed Central
Buy Erythromycin Without Prescription
Sanofi Pasteur's Dengue Vaccine In Final Stage Of Clinical Development
Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced that its dengue vaccine is in final stage of clinical development. Sanofi Pasteur's dengue vaccine, the world's most clinically advanced dengue vaccine candidate(1,2), entered its first phase 3 clinical study in Australia.
This study is part of a global phase 3 clinical study program aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur.(3)
Phase 3 studies are the ultimate steps in the clinical development of a vaccine before it is submitted to regulatory authorities for evaluation for market authorization. Sanofi Pasteur's candidate dengue vaccine is the first to reach phase 3 of clinical development.
"To address the global health challenge represented by dengue fever, we are conducting an unprecedented dengue vaccine research and development program as well as a scale up of the vaccine production," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "We are now entering the final laps of a long run that Sanofi Pasteur started almost 20 years ago. If successful, we are committed to introducing the vaccine in countries where dengue is of highest public health priority."
The study in Australia is the first to use dengue vaccine doses produced with industrial scale processes. The study is aimed at demonstrating that production of the vaccine at industrial scale will meet consistency criteria required for market authorization by regulatory authorities. Details of the phase 3 study in Australia as well as results of already completed studies are presented at the 59th annual conference of ASTMH (American Society of Tropical Medicine and Hygiene), held in Atlanta (Georgia, United States), November 3-7.
Sanofi Pasteur's global dengue vaccine clinical study program
Sanofi Pasteur's candidate dengue vaccine-which targets all four virus serotypes-has been evaluated in clinical studies (Phase 1, 2) in adults and children in the U.S., Asia and Latin America. Overall, a balanced immune response against all four serotypes was observed after three doses of the vaccine. The vaccine is well tolerated with a similar safety profile after each dose.(4)
Clinical studies in adults and children are ongoing in Mexico, Colombia, Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore, Australia, and Thailand.
About dengue fever
Dengue fever is a mosquito-borne disease caused by four dengue virus serotypes (1 to 4). Overall, the disease is a potential threat to almost half of the world's population. Of the estimated 220 million people infected annually, two million-mostly children-develop dengue hemorrhagic fever (DHF), a severe form of the disease.(5) DHF is a leading cause of hospitalization, placing tremendous pressure on strained medical resources and having a heavy economic and societal impact. Many factors have contributed to the re-emergence and dramatic increase in dengue fever including urbanization and increased travel which facilitates dissemination of dengue viruses and the circulation of all four dengue virus serotypes.
References
1. Dengue vaccine efficacy trials in progress vol 9, November 2009
2. Jean Lang, Recent progress on Sanofi Pasteur's dengue vaccine candidate. Journal of Clinical Virology 46, S2 (2009) 20-24
3. WHO Fact sheet No117, March 2009 Dengue and dengue haemorrhagic fever
4. Saville et al, Clinical development of a tetravalent dengue vaccine for endemic areas, ICID Miami, March 2010; Lang et al, Toward a tetravalent dengue vaccine in Brazil, Tropical Medicine meeting, Iguacu Falls, March 2010
5. PDVI Newsletter No 7, April 2010
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2009. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Source: Sanofi Pasteur
Buy Zovirax Without Prescription
This study is part of a global phase 3 clinical study program aimed at advancing the development of a novel vaccine for the prevention of dengue disease in children and adults. Currently, there is no specific treatment available for dengue fever, which is a threat to nearly three billion people and a public health priority in many countries of Latin America and Asia where epidemics occur.(3)
Phase 3 studies are the ultimate steps in the clinical development of a vaccine before it is submitted to regulatory authorities for evaluation for market authorization. Sanofi Pasteur's candidate dengue vaccine is the first to reach phase 3 of clinical development.
"To address the global health challenge represented by dengue fever, we are conducting an unprecedented dengue vaccine research and development program as well as a scale up of the vaccine production," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "We are now entering the final laps of a long run that Sanofi Pasteur started almost 20 years ago. If successful, we are committed to introducing the vaccine in countries where dengue is of highest public health priority."
The study in Australia is the first to use dengue vaccine doses produced with industrial scale processes. The study is aimed at demonstrating that production of the vaccine at industrial scale will meet consistency criteria required for market authorization by regulatory authorities. Details of the phase 3 study in Australia as well as results of already completed studies are presented at the 59th annual conference of ASTMH (American Society of Tropical Medicine and Hygiene), held in Atlanta (Georgia, United States), November 3-7.
Sanofi Pasteur's global dengue vaccine clinical study program
Sanofi Pasteur's candidate dengue vaccine-which targets all four virus serotypes-has been evaluated in clinical studies (Phase 1, 2) in adults and children in the U.S., Asia and Latin America. Overall, a balanced immune response against all four serotypes was observed after three doses of the vaccine. The vaccine is well tolerated with a similar safety profile after each dose.(4)
Clinical studies in adults and children are ongoing in Mexico, Colombia, Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore, Australia, and Thailand.
About dengue fever
Dengue fever is a mosquito-borne disease caused by four dengue virus serotypes (1 to 4). Overall, the disease is a potential threat to almost half of the world's population. Of the estimated 220 million people infected annually, two million-mostly children-develop dengue hemorrhagic fever (DHF), a severe form of the disease.(5) DHF is a leading cause of hospitalization, placing tremendous pressure on strained medical resources and having a heavy economic and societal impact. Many factors have contributed to the re-emergence and dramatic increase in dengue fever including urbanization and increased travel which facilitates dissemination of dengue viruses and the circulation of all four dengue virus serotypes.
References
1. Dengue vaccine efficacy trials in progress vol 9, November 2009
2. Jean Lang, Recent progress on Sanofi Pasteur's dengue vaccine candidate. Journal of Clinical Virology 46, S2 (2009) 20-24
3. WHO Fact sheet No117, March 2009 Dengue and dengue haemorrhagic fever
4. Saville et al, Clinical development of a tetravalent dengue vaccine for endemic areas, ICID Miami, March 2010; Lang et al, Toward a tetravalent dengue vaccine in Brazil, Tropical Medicine meeting, Iguacu Falls, March 2010
5. PDVI Newsletter No 7, April 2010
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2009. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Source: Sanofi Pasteur
Buy Zovirax Without Prescription
Five Research Studies At International SRCD Meeting In Denver Use Technology From Boulder Foundation
The not-for-profit LENA Foundation is putting forth a strong presence at the 2009 Biennial Meeting of the Society of Research in Child Development (SRCD). At the event, April 1-4 in Denver, Colorado, four talks and one poster will be presented based on findings using LENA System technology.
"This year's SRCD is a great opportunity for our colleagues to see how LENA technology is fostering discoveries in different disciplines," said Jill Gilkerson, Ph.D., the foundation's language research director. "We're making strides with children with language delays and disorders, including significant advancements toward releasing an automatic autism screen."
A special preconference event on the development of children with hearing loss launches the SRCD conference on Wednesday, April 1. From 11:10 a.m. to 11:40 a.m., Gilkerson presents "Automatic Assessment of the Language Environment of Infants and Toddlers." LENA Foundation scientific advisor D. Kimbrough Oller, Ph.D., follows Gilkerson with "Naturalistic Recording and Representative Sampling of Vocal Behavior: Prospects for Screening, Diagnosis, and Monitoring of Progress in Intervention" from 11:40 a.m. to 12:10 p.m.
International expert on children and the media, Dimitri A. Christakis, will give a Pecha Kucha presentation from 10:20 a.m. to noon on Thursday, April 2. The presentation, "TV Displaces Talk: The Relationship Between TV Exposure and Family Interaction," is based on data from the LENA Natural Language Study.
Researchers with the Stanford University Center for Infant Studies will present the poster "Using the LENA Automated Speech Analysis System to Explore the Language Environments of Latino Children Learning Spanish" from 8:20 a.m. to 10:00 a.m. on Friday, April 3.
During the paper symposium Cry and Non-Cry Vocalizations in Autism: Potential Markers in Infancy, from 4:20 p.m. to 6:00 p.m. on Saturday, April 4, Oller and foundation scientists will present "Automated Assessment of Naturalistic Recordings as a Potential Diagnostic Tool for Autism." Utilizing a unique acoustic analysis of non-cry vocalizations, this paper provides evidence that atypical vocal quality discriminates children 16 months to 48 months with autism from children with language delay.
For more information on SRCD, visit srcd/index.php?option=com_content&task=view&id=134&Itemid
About LENA Foundation
Established in 2009, the LENA Foundation develops advanced technology for the early screening, diagnosis, research, and treatment of language delays and disorders in children and adults. Philanthropists Terry and Judi Paul formed the not-for-profit organization through a multimillion-dollar gift and the donation of assets from Infoture Inc. Over a five-year period, Infoture created the LENA (Language ENvironment Analysis) System, the world's first automatic language collection and analysis tool and the foundation's principal product. The foundation employs a team of scientists and engineers who are skilled in computerized speech and speaker recognition, microelectronics, statistical research, and children's language acquisition and development; they are passionately devoted to helping the foundation enhance language development worldwide.
LENA Foundation
lenafoundation
Buy Declomycin Without Prescription
"This year's SRCD is a great opportunity for our colleagues to see how LENA technology is fostering discoveries in different disciplines," said Jill Gilkerson, Ph.D., the foundation's language research director. "We're making strides with children with language delays and disorders, including significant advancements toward releasing an automatic autism screen."
A special preconference event on the development of children with hearing loss launches the SRCD conference on Wednesday, April 1. From 11:10 a.m. to 11:40 a.m., Gilkerson presents "Automatic Assessment of the Language Environment of Infants and Toddlers." LENA Foundation scientific advisor D. Kimbrough Oller, Ph.D., follows Gilkerson with "Naturalistic Recording and Representative Sampling of Vocal Behavior: Prospects for Screening, Diagnosis, and Monitoring of Progress in Intervention" from 11:40 a.m. to 12:10 p.m.
International expert on children and the media, Dimitri A. Christakis, will give a Pecha Kucha presentation from 10:20 a.m. to noon on Thursday, April 2. The presentation, "TV Displaces Talk: The Relationship Between TV Exposure and Family Interaction," is based on data from the LENA Natural Language Study.
Researchers with the Stanford University Center for Infant Studies will present the poster "Using the LENA Automated Speech Analysis System to Explore the Language Environments of Latino Children Learning Spanish" from 8:20 a.m. to 10:00 a.m. on Friday, April 3.
During the paper symposium Cry and Non-Cry Vocalizations in Autism: Potential Markers in Infancy, from 4:20 p.m. to 6:00 p.m. on Saturday, April 4, Oller and foundation scientists will present "Automated Assessment of Naturalistic Recordings as a Potential Diagnostic Tool for Autism." Utilizing a unique acoustic analysis of non-cry vocalizations, this paper provides evidence that atypical vocal quality discriminates children 16 months to 48 months with autism from children with language delay.
For more information on SRCD, visit srcd/index.php?option=com_content&task=view&id=134&Itemid
About LENA Foundation
Established in 2009, the LENA Foundation develops advanced technology for the early screening, diagnosis, research, and treatment of language delays and disorders in children and adults. Philanthropists Terry and Judi Paul formed the not-for-profit organization through a multimillion-dollar gift and the donation of assets from Infoture Inc. Over a five-year period, Infoture created the LENA (Language ENvironment Analysis) System, the world's first automatic language collection and analysis tool and the foundation's principal product. The foundation employs a team of scientists and engineers who are skilled in computerized speech and speaker recognition, microelectronics, statistical research, and children's language acquisition and development; they are passionately devoted to helping the foundation enhance language development worldwide.
LENA Foundation
lenafoundation
Buy Declomycin Without Prescription
UCLA Neuroscience Research Leads To A Possible Treatment For Type 1 Diabetes
A new vaccine being tested in a human clinical trial holds a great deal of promise for treating type 1 diabetes, a disease that newly afflicts 35,000 children each year. The research that established the foundation for this vaccine was conducted in UCLA research laboratories. The drug is still being tested and is not likely to be available for at least a few years.
"It's the only thing so far that really slows this disease down without adverse side effects," Allan J. Tobin, a UCLA professor emeritus of physiological science and neurology, said about the new drug. "The amazing thing about this emerging story, however, is that it started from basic research on the brain." Tobin, whose laboratory conducted critical neuroscience research in the late 1980s and 1990s, is a member and former director of UCLA's Brain Research Institute.
Type 1 diabetes -- also known as insulin-dependent diabetes or juvenile diabetes (because it usually begins in childhood or adolescence) -- afflicts more than 1 million Americans. It is characterized by a failure of the body to produce insulin because the immune system attacks and destroys the body's insulin-producing cells of the pancreas.
On Sunday, Sept. 17, at a meeting in Copenhagen of the European Association for the Study of Diabetes, Johnny Ludvigsson -- pediatrics professor at Sweden's University Hospital, Linkoping University -- presented results from the phase II study conducted in eight hospitals in Sweden in collaboration with Diamyd Medical, a life science company located in Stockholm, Sweden.
This fundamental discovery that influenced thinking about diabetes was made in the Life Sciences Division of UCLA's College of Letters and Science, said Arthur P. Arnold, UCLA professor and chair of physiological science.
"The broad insight of a basic neuroscience team eventually bore fruit in the fight against this disease," Arnold said. In the 1980s, using newly developed recombinant DNA techniques, Tobin's laboratory was studying genes involved in brain development and function. Tobin's team included graduate student Daniel Kaufman, now a UCLA professor in the department of molecular and medical pharmacology, and graduate student Mark Erlander, now executive vice president and chief scientific officer of AviaraDx, a biotechnology company in Carlsbad, Calif.
Together, Kaufman and Erlander were the first to isolate the genes encoding GAD (glutamic acid decarboxylase) which is an important enzyme because it synthesizes one of the main neurotransmitters for communication between neurons. Tobin's laboratory used these tools to study neuronal development in the brain. What no one knew at that time was that GAD was also made in the cells that made insulin in the pancreas -- cells that use the chemical transmitter made by GAD to communicate with other pancreas cells to help control glucose levels in the blood.
A year later, Kaufman's car fortuitously broke down while he was a postdoctoral scholar at the Salk Institute in San Diego, Calif. Forced to wait, he went to the library and stumbled on a report in a medical journal showing a connection between autoimmunity to an unknown protein in insulin-producing cells and diabetes. Kaufman surmised that this unknown protein was in fact GAD, the protein he had studied in Tobin's lab.
To study the possible connection between GAD and diabetes, Kaufman again worked with Tobin and Erlander, using the research tools they had developed to test whether autoantibodies against GAD could be found in frozen blood samples taken from individuals before they developed type 1 diabetes. They found that they could detect autoantibodies against GAD years before the symptoms of diabetes appeared.
In type 1 diabetes, the immune system destroys the insulin-producing cells slowly, over as many as seven years before any symptoms appear, Tobin said. "These tools allowed us to detect the early appearance of an autoimmune reaction more than five years before the onset of diabetes," Tobin said.
Many laboratories throughout the world are now using recombinant GAD to determine whether individuals have autoantibodies to GAD and are likely to develop diabetes. This pre-diagnostic test will be invaluable for preventing diabetes -- but first, there must be a therapeutic to slow the progression of the disease.
In his own laboratory at UCLA, Kaufman, along with UCLA's Jide Tian, Michael Clare-Salzler, Eli Sercarz, Paul Lehmann and Tobin, searched for ways to "tolerize" the immune system of diabetes-prone mice to the GAD protein before the autoimmune attack began. The team reported in the journal Nature in 1993 that when young, diabetes-prone mice were treated with a small amount of the GAD protein, their immune systems learned to tolerate the protein. The autoimmune response that leads to type 1 diabetes never developed in these mice as they grew older.
Next, Kaufman and Tian developed the GAD vaccine that was able to inhibit the autoimmune response after it had already begun to attack the insulin producing cells. Kaufman and Tian showed in a study they published in Nature-Medicine in 1996 that, even after the type 1 diabetes disease process had started in diabetes-prone mice, its progression could be inhibited by the GAD vaccine.
The GAD vaccine activated T-cells that recognized GAD, Kaufman and Tian reported. "The T-cells traveled to the pancreas and, recognizing the GAD protein in the insulin-producing cells there, released calming substances called 'anti-inflammatory' cytokines, which suppressed the immune cells that were killing the insulin-producing cells," Tian explained.
UCLA licensed the technology to Diamyd Medical for clinical development. Tobin and Kaufman both serve on the scientific advisory board of Diamyd.
Based on the success of the GAD vaccine to prevent diabetes in mice, Diamyd Medical conducted a phase II clinical trial by treating adults who recently had been diagnosed with diabetes. The results showed that treatment with the GAD vaccine could preserve some insulin production for at least two years after the onset of the disease in adults.
Given these promising results, Diamyd next conducted a larger double-blind clinical trial of the GAD vaccine in 70 children and adolescents who were newly diagnosed with diabetes. After treating new diabetics with the GAD vaccine, or a placebo, the patients were followed for 15 months, without the clinicians knowing which treatment the patients had received. This month Diamyd Medical broke the code and announced that the GAD vaccine demonstrated statistically significant efficacy in preserving insulin production and that no serious adverse events associated with the therapy were observed.
Tobin and Kaufman are optimistic about the drug, which is called Diamyd, but both said it is likely to be at least a few years before a drug for type 1 diabetes is available.
"If the result holds up in a phase III trial, it's going to make a big difference," Tobin said. "It feels terrific."
"It's tremendously gratifying to see our work go from the lab to a clinical application, with the potential to help so many people," Kaufman said. "The data are very strong, and are convincing even to scientists who were initially skeptical. The vaccine is highly targeted; it activates only the immune cells that recognize GAD, which then suppresses the immune cells that are attacking the insulin-producing cells. Most of us who go into science hope our research will advance medical treatment and improve human lives; it's great news."
He added, "Such long-term preservation of insulin production after the onset of diabetes is quite remarkable. Preserving insulin-production is crucial for delaying the complications associated with long-term diabetes, such as kidney and heart disease, and neuropathy. Now that the vaccine has shown efficacy in preserving insulin production after disease onset, we are anxious to see whether the vaccine can also prevent the development of type 1 diabetes."
The children who are likely to develop type 1 diabetes can be identified by screening for autoantibodies to GAD in their blood, Kaufman said. Tobin, 64, is currently managing director of MRSSI, which advises two nonprofit organizations, the High Q Foundation and CHDI, both dedicated to finding therapies for Huntington's disease. From 1975 to 2003, he was on the faculty of UCLA, where he taught introductory biology and neuroscience. He is the coauthor of "Asking About Life," a prize-winning biology textbook whose premise is that questions are more important than answers.
Tobin's research was funded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health. Kaufman's research is funded by the National Institute of Diabetes & Digestive & Kidney Diseases, also part of part of the National Institutes of Health.
Tobin recalls bringing the excitement of his research into the UCLA classes he taught.
"When I taught the introductory biology course, I said here's the standard stuff about the immune system, but let me tell you about something that just happened in my lab," Tobin recalled. "There's a thrill of discovery, and also a sense that there remain challenges ahead; science isn't just learning a set of facts but learning how to approach and formulate scientific problems. That engagement really serves undergraduates at UCLA very differently from undergraduates at non-research colleges."
As is often true in science, solutions to important problems come from unexpected places, and basic research provides the foundation for future applications.
"Type 1 diabetes never occurred to me," Tobin said. "I was interested in how cells in the brain signal one another. We were trying to understand how some cells in the brain told other cells to slow down or stop.
"One of the great things about UCLA's College of Letters and Science is that scientists working on basic questions talk with one another and with medical school scientists. At first it wasn't obvious that inhibitory signaling in the brain and in the pancreas uses the same molecules, but they do. The diabetes diagnostic and therapeutic came out of basic research in an unpredictable way."
California's largest university, UCLA enrolls approximately 38,000 students per year and offers degrees from the UCLA College of Letters and Science and 11 professional schools in dozens of varied disciplines. UCLA consistently ranks among the top five universities and colleges nationally in total research-and-development spending, receiving more than $820 million a year in competitively awarded federal and state grants and contracts. For every $1 state taxpayers invest in UCLA, the university generates almost $9 in economic activity, resulting in an annual $6 billion economic impact on the Greater Los Angeles region. The university's healthcare network treats 450,000 patients per year. UCLA employs more than 27,000 faculty and staff, has more than 350,000 living alumni and has been home to five Nobel Prize recipients.
Contact: Stuart Wolpert
University of California - Los Angeles
Buy Avelox Without Prescription
"It's the only thing so far that really slows this disease down without adverse side effects," Allan J. Tobin, a UCLA professor emeritus of physiological science and neurology, said about the new drug. "The amazing thing about this emerging story, however, is that it started from basic research on the brain." Tobin, whose laboratory conducted critical neuroscience research in the late 1980s and 1990s, is a member and former director of UCLA's Brain Research Institute.
Type 1 diabetes -- also known as insulin-dependent diabetes or juvenile diabetes (because it usually begins in childhood or adolescence) -- afflicts more than 1 million Americans. It is characterized by a failure of the body to produce insulin because the immune system attacks and destroys the body's insulin-producing cells of the pancreas.
On Sunday, Sept. 17, at a meeting in Copenhagen of the European Association for the Study of Diabetes, Johnny Ludvigsson -- pediatrics professor at Sweden's University Hospital, Linkoping University -- presented results from the phase II study conducted in eight hospitals in Sweden in collaboration with Diamyd Medical, a life science company located in Stockholm, Sweden.
This fundamental discovery that influenced thinking about diabetes was made in the Life Sciences Division of UCLA's College of Letters and Science, said Arthur P. Arnold, UCLA professor and chair of physiological science.
"The broad insight of a basic neuroscience team eventually bore fruit in the fight against this disease," Arnold said. In the 1980s, using newly developed recombinant DNA techniques, Tobin's laboratory was studying genes involved in brain development and function. Tobin's team included graduate student Daniel Kaufman, now a UCLA professor in the department of molecular and medical pharmacology, and graduate student Mark Erlander, now executive vice president and chief scientific officer of AviaraDx, a biotechnology company in Carlsbad, Calif.
Together, Kaufman and Erlander were the first to isolate the genes encoding GAD (glutamic acid decarboxylase) which is an important enzyme because it synthesizes one of the main neurotransmitters for communication between neurons. Tobin's laboratory used these tools to study neuronal development in the brain. What no one knew at that time was that GAD was also made in the cells that made insulin in the pancreas -- cells that use the chemical transmitter made by GAD to communicate with other pancreas cells to help control glucose levels in the blood.
A year later, Kaufman's car fortuitously broke down while he was a postdoctoral scholar at the Salk Institute in San Diego, Calif. Forced to wait, he went to the library and stumbled on a report in a medical journal showing a connection between autoimmunity to an unknown protein in insulin-producing cells and diabetes. Kaufman surmised that this unknown protein was in fact GAD, the protein he had studied in Tobin's lab.
To study the possible connection between GAD and diabetes, Kaufman again worked with Tobin and Erlander, using the research tools they had developed to test whether autoantibodies against GAD could be found in frozen blood samples taken from individuals before they developed type 1 diabetes. They found that they could detect autoantibodies against GAD years before the symptoms of diabetes appeared.
In type 1 diabetes, the immune system destroys the insulin-producing cells slowly, over as many as seven years before any symptoms appear, Tobin said. "These tools allowed us to detect the early appearance of an autoimmune reaction more than five years before the onset of diabetes," Tobin said.
Many laboratories throughout the world are now using recombinant GAD to determine whether individuals have autoantibodies to GAD and are likely to develop diabetes. This pre-diagnostic test will be invaluable for preventing diabetes -- but first, there must be a therapeutic to slow the progression of the disease.
In his own laboratory at UCLA, Kaufman, along with UCLA's Jide Tian, Michael Clare-Salzler, Eli Sercarz, Paul Lehmann and Tobin, searched for ways to "tolerize" the immune system of diabetes-prone mice to the GAD protein before the autoimmune attack began. The team reported in the journal Nature in 1993 that when young, diabetes-prone mice were treated with a small amount of the GAD protein, their immune systems learned to tolerate the protein. The autoimmune response that leads to type 1 diabetes never developed in these mice as they grew older.
Next, Kaufman and Tian developed the GAD vaccine that was able to inhibit the autoimmune response after it had already begun to attack the insulin producing cells. Kaufman and Tian showed in a study they published in Nature-Medicine in 1996 that, even after the type 1 diabetes disease process had started in diabetes-prone mice, its progression could be inhibited by the GAD vaccine.
The GAD vaccine activated T-cells that recognized GAD, Kaufman and Tian reported. "The T-cells traveled to the pancreas and, recognizing the GAD protein in the insulin-producing cells there, released calming substances called 'anti-inflammatory' cytokines, which suppressed the immune cells that were killing the insulin-producing cells," Tian explained.
UCLA licensed the technology to Diamyd Medical for clinical development. Tobin and Kaufman both serve on the scientific advisory board of Diamyd.
Based on the success of the GAD vaccine to prevent diabetes in mice, Diamyd Medical conducted a phase II clinical trial by treating adults who recently had been diagnosed with diabetes. The results showed that treatment with the GAD vaccine could preserve some insulin production for at least two years after the onset of the disease in adults.
Given these promising results, Diamyd next conducted a larger double-blind clinical trial of the GAD vaccine in 70 children and adolescents who were newly diagnosed with diabetes. After treating new diabetics with the GAD vaccine, or a placebo, the patients were followed for 15 months, without the clinicians knowing which treatment the patients had received. This month Diamyd Medical broke the code and announced that the GAD vaccine demonstrated statistically significant efficacy in preserving insulin production and that no serious adverse events associated with the therapy were observed.
Tobin and Kaufman are optimistic about the drug, which is called Diamyd, but both said it is likely to be at least a few years before a drug for type 1 diabetes is available.
"If the result holds up in a phase III trial, it's going to make a big difference," Tobin said. "It feels terrific."
"It's tremendously gratifying to see our work go from the lab to a clinical application, with the potential to help so many people," Kaufman said. "The data are very strong, and are convincing even to scientists who were initially skeptical. The vaccine is highly targeted; it activates only the immune cells that recognize GAD, which then suppresses the immune cells that are attacking the insulin-producing cells. Most of us who go into science hope our research will advance medical treatment and improve human lives; it's great news."
He added, "Such long-term preservation of insulin production after the onset of diabetes is quite remarkable. Preserving insulin-production is crucial for delaying the complications associated with long-term diabetes, such as kidney and heart disease, and neuropathy. Now that the vaccine has shown efficacy in preserving insulin production after disease onset, we are anxious to see whether the vaccine can also prevent the development of type 1 diabetes."
The children who are likely to develop type 1 diabetes can be identified by screening for autoantibodies to GAD in their blood, Kaufman said. Tobin, 64, is currently managing director of MRSSI, which advises two nonprofit organizations, the High Q Foundation and CHDI, both dedicated to finding therapies for Huntington's disease. From 1975 to 2003, he was on the faculty of UCLA, where he taught introductory biology and neuroscience. He is the coauthor of "Asking About Life," a prize-winning biology textbook whose premise is that questions are more important than answers.
Tobin's research was funded by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health. Kaufman's research is funded by the National Institute of Diabetes & Digestive & Kidney Diseases, also part of part of the National Institutes of Health.
Tobin recalls bringing the excitement of his research into the UCLA classes he taught.
"When I taught the introductory biology course, I said here's the standard stuff about the immune system, but let me tell you about something that just happened in my lab," Tobin recalled. "There's a thrill of discovery, and also a sense that there remain challenges ahead; science isn't just learning a set of facts but learning how to approach and formulate scientific problems. That engagement really serves undergraduates at UCLA very differently from undergraduates at non-research colleges."
As is often true in science, solutions to important problems come from unexpected places, and basic research provides the foundation for future applications.
"Type 1 diabetes never occurred to me," Tobin said. "I was interested in how cells in the brain signal one another. We were trying to understand how some cells in the brain told other cells to slow down or stop.
"One of the great things about UCLA's College of Letters and Science is that scientists working on basic questions talk with one another and with medical school scientists. At first it wasn't obvious that inhibitory signaling in the brain and in the pancreas uses the same molecules, but they do. The diabetes diagnostic and therapeutic came out of basic research in an unpredictable way."
California's largest university, UCLA enrolls approximately 38,000 students per year and offers degrees from the UCLA College of Letters and Science and 11 professional schools in dozens of varied disciplines. UCLA consistently ranks among the top five universities and colleges nationally in total research-and-development spending, receiving more than $820 million a year in competitively awarded federal and state grants and contracts. For every $1 state taxpayers invest in UCLA, the university generates almost $9 in economic activity, resulting in an annual $6 billion economic impact on the Greater Los Angeles region. The university's healthcare network treats 450,000 patients per year. UCLA employs more than 27,000 faculty and staff, has more than 350,000 living alumni and has been home to five Nobel Prize recipients.
Contact: Stuart Wolpert
University of California - Los Angeles
Buy Avelox Without Prescription
Preventing Pancreatic Islet Loss After Transplantation
Although transplantation of pancreatic islets is an attractive way to treat type 1 diabetes, early islet loss soon after transplantation has limited its clinical use. By studying islet transplantation in a mouse model of diabetes, a team of researchers, at the RIKEN Research Center for Allergy and Immunology, Japan, and Fukuoka University, Japan, has now identified a potential new set of targets to improve the efficiency of pancreatic islet transplantation.
Previous studies have identified an immune mechanism essential for early loss of transplanted islets: immune cells expressing the proteins Gr-1 and CD11b produce the soluble molecule IFN-gamma in a process that is dependent on immune cells known as NKT cells. The team, led by Masaru Taniguchi and Yohichi Yasunami, found that the protein HMGB1 plays a crucial role in the initial events of early loss of transplanted islets in the mouse model of diabetes. Of potential clinical significance, treatment with an antibody targeting HMGB1 prevented early pancreatic islet loss and inhibited IFN-gamma production by NKT cells and Gr-1+CD11b+ cells. Furthermore, mice lacking either of the two proteins to which HMGB1 binds failed to exhibit early pancreatic islet loss. Additional analysis identified the molecular pathway linking HMGB1 to NKT cell activation and subsequent NKT cell-dependent IFN-gamma production by Gr-1+CD11b+ cells, and targeting some of these molecules prevented early pancreatic islet loss. These data provide several potential drug targets for improving the efficiency of pancreatic islet transplantation in humans.
TITLE: High-mobility group box 1 is involved in the initial events of early loss of transplanted islets in mice
View this article at: jci/articles/view/41360?key=82f6533c5783a48c4c6c
AUTHOR CONTACT:
Masaru Taniguchi
RIKEN Research Center for Allergy and Immunology, Yokohama, Japan.
Yohichi Yasunami
Faculty of Medicine Fukuoka University, Fukuoka, Japan.
Source:
Karen Honey
Journal of Clinical Investigation
Buy Famvir Without Prescription
Previous studies have identified an immune mechanism essential for early loss of transplanted islets: immune cells expressing the proteins Gr-1 and CD11b produce the soluble molecule IFN-gamma in a process that is dependent on immune cells known as NKT cells. The team, led by Masaru Taniguchi and Yohichi Yasunami, found that the protein HMGB1 plays a crucial role in the initial events of early loss of transplanted islets in the mouse model of diabetes. Of potential clinical significance, treatment with an antibody targeting HMGB1 prevented early pancreatic islet loss and inhibited IFN-gamma production by NKT cells and Gr-1+CD11b+ cells. Furthermore, mice lacking either of the two proteins to which HMGB1 binds failed to exhibit early pancreatic islet loss. Additional analysis identified the molecular pathway linking HMGB1 to NKT cell activation and subsequent NKT cell-dependent IFN-gamma production by Gr-1+CD11b+ cells, and targeting some of these molecules prevented early pancreatic islet loss. These data provide several potential drug targets for improving the efficiency of pancreatic islet transplantation in humans.
TITLE: High-mobility group box 1 is involved in the initial events of early loss of transplanted islets in mice
View this article at: jci/articles/view/41360?key=82f6533c5783a48c4c6c
AUTHOR CONTACT:
Masaru Taniguchi
RIKEN Research Center for Allergy and Immunology, Yokohama, Japan.
Yohichi Yasunami
Faculty of Medicine Fukuoka University, Fukuoka, Japan.
Source:
Karen Honey
Journal of Clinical Investigation
Buy Famvir Without Prescription
Data At ASH, SABCS Demonstrate Commitment Of Novartis R&D In Advancing Treatments For Patients With Cancer And Rare Diseases
With more than 170 presentations focused on its marketed and pipeline compounds at key oncology medical congresses in December, Novartis continues to demonstrate progress of its innovative research and development efforts, collaboration with the scientific community and commitment to patients with cancer and rare diseases(1,2).
The American Society of Hematology (ASH) annual meeting in Orlando, FL (December 4-7) will feature 30 oral presentations on Novartis Oncology compounds including Tasigna® (nilotinib) 150 mg capsules, Gleevec® (imatinib mesylate) tablets, Afinitor® (everolimus) tablets, Exjade® (deferasirox), Zometa® (zoledronic acid) and LBH589 (panobinostat)(1). The San Antonio Breast Cancer Symposium (SABCS), beginning December 8, will feature presentations on everolimus and Zometa(2).
"These data highlight progress of our hematology and oncology research with a focus on developing new treatment approaches based on an understanding of the molecular pathways involved in diseases," said Herve Hoppenot, President of Novartis Oncology. "Our goal is to bring the right treatment to the right patient across a broad range of cancers and rare diseases."
Key presentations at ASH include:
-- Tasigna - ENESTnd 24-month update comparing Tasigna to Gleevec in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (ASH Abstract #207; Dec. 6; 7:30 AM EST) (3).
-- Afinitor - Two studies showing activity of everolimus in mantle cell lymphoma (ASH Abstract #2803; Dec. 5; 6:00-8:00 PM EST)(4); (ASH Abstract #3963; Dec. 6; 6:00-8:00 PM EST)(5).
-- Exjade - EPIC sub-studies presenting three-year, end-of-study data on cardiac iron removal (ASH Abstract #4276; Dec. 6; 6:00-8:00 PM EST)(6) and post-hoc analysis from a large study reporting hematologic response in a cohort of MDS patients (ASH Abstract #2912; Dec. 5; 6:00-8:00 PM EST)(7); the first study (109E) to report on long-term safety and efficacy in sickle-cell disease patients up to five years (ASH Abstract #845; Dec. 6; 7:15 PM EST)(8); and the first large study (107E/108E) to assess effect of iron chelation therapy on liver pathology in large cohort of beta-thalassemia patients (ASH Abstract #4274; Dec. 6; 6:00-8:00 PM EST)(9).
-- Zometa - Phase III data evaluating Zometa in the treatment of patients with newly diagnosed multiple myeloma (ASH Abstract #311; Dec. 6; 8:00 AM EST)(10).
-- LBH589 (panobinostat) - Pivotal Phase II data for LBH589 in the treatment of Hodgkin lymphoma patients who relapse or are refractory after autologous stem cell transplant (ASH Abstract #419; Dec. 6; 11:30 AM EST)(11).
-- INC424 - Phase II data showing response rates to INC424 in patients with polycythemia vera (ASH Abstract #313; Dec. 6; 7:00 AM EST)(12); Phase II data of INC424 in patients with refractory leukemias including post-myeloproliferative disorder and acute myeloid leukemia (ASH Abstract #509; Dec. 6; 3:45 PM EST)(13).
-- PKC412 (midostaurin) - Phase II data evaluating midostaurin in the treatment of aggressive systemic mastocytosis (ASH Abstract #316; Dec. 6; 7:45 AM EST)(14).
-- HCD122 (lucatumumab) - Clinical activity evaluated in patients with relapsed/refractory Hodgkin or non-Hodgkin lymphoma treated in a Phase Ia/II trial (ASH Abstract #284; Dec. 6; 7:15 AM EST)(15).
Key presentations at SABCS include:
-- Afinitor - TAMRAD Phase II data on everolimus in the treatment of ER+/HER2- metastatic breast cancer after failure of aromatase inhibitors (SABCS Abstract #S1-6; Dec. 9; 10:30 AM CST)(16).
-- Zometa - Phase III data from the AZURE trial (BIG 01/04) of adjuvant treatment with Zometa in stage II/III breast cancer (SABCS Abstract #S4-5; Dec. 10; 4:15 PM CST)(17); Phase III data analyses from the ABCSG-12 trial evaluating the carry-over effect of Zometa in premenopausal women with early breast cancer after completion of therapy (SABCS Abstract #P5-11-02; Dec. 11; 5:30-7:30 PM CST)(18).
-- BEZ235 - Clinical data from a dose-escalation study with a special drug delivery system of BEZ235 in patients with metastatic/advanced solid tumors (SABCS Abstract #P6-15-07; Dec. 12, 7:00-8:30 PM CST)(19).
About Tasigna
Tasigna® (nilotinib) is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of Tasigna is based on major molecular response and cytogenetic response rates. The study is ongoing and further data will be required to determine long-term outcome.
Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Tasigna has been approved in more than 80 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including Gleevec. The effectiveness of Tasigna for this indication is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Tasigna important safety information
Tasigna can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death.
Your doctor should check the electrical activity of your heart with a test called an electrocardiogram (ECG):
-- Before starting Tasigna
-- 7 days after starting Tasigna
-- With any dose changes
-- Regularly during Tasigna treatment
You may lower your chances for having QTc prolongation with Tasigna if you:
Take Tasigna:
-- On an empty stomach. Do not take Tasigna with food.
-- At least 2 hours after eating any food, and
-- Wait at least 1 hour before eating any food
-- Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking Tasigna. Food and grapefruit products increase the amount of Tasigna in your body.
-- Avoid taking other medicines or supplements with Tasigna that can also cause QTc prolongation.
-- Tasigna can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.
-- Do not take any other medicine while taking Tasigna unless your doctor tells you it is okay to do so.
Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking Tasigna. These can be symptoms of QTc prolongation.
What is Tasigna?
Tasigna is a prescription medicine used to treat a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults who:
-- Are newly diagnosed, or
-- Are no longer benefiting from previous other treatments, including treatment with imatinib (Gleevec®), or
-- Have taken other treatments, including imatinib (Gleevec®), and cannot tolerate them
It is not known if Tasigna is safe or effective in children.
Who should not take Tasigna?
Do not take if you have:
-- Low levels of potassium or magnesium in your blood
-- Long QTc syndrome
What should I tell my doctor before starting Tasigna?
Tasigna may not be right for you. Before taking Tasigna, tell your doctor about all of your medical conditions, including if you have:
-- Heart problems
-- Irregular heartbeat
-- QTc prolongation or a family history of it
-- Liver problems
-- Had pancreatitis
-- Low blood levels of potassium or magnesium in your blood
-- A severe problem with lactose (milk sugar) or other sugars. The Tasigna capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take Tasigna.
-- Had a surgical procedure involving the removal of the entire stomach (total gastrectomy)
-- Are pregnant or plan to become pregnant. Tasigna may harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment with Tasigna. Talk to your doctor about the best birth control methods to prevent pregnancy while you are taking Tasigna.
-- Are breastfeeding or plan to breastfeed. It is not known if Tasigna passes into your breast milk. You and your doctor should decide if you will take Tasigna or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and non prescription medicines, vitamins and herbal supplements.
Tasigna can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects. See "What is the most important information I should know about Tasigna?"
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take Tasigna?
-- Take Tasigna exactly as your doctor tells you to take it. Do not change your dose or stop taking Tasigna unless your doctor tells you.
-- Tasigna is a long-term treatment.
-- Your doctor will tell you how many Tasigna capsules to take and when to take them.
-- Do not take Tasigna with food. Take Tasigna at least 2 hours after you eat and at least 1 hour before you eat.
-- Swallow Tasigna capsules whole with water. If you cannot swallow Tasigna capsules whole, tell your doctor.
-- Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract at any time during treatment. See "What is the most important information I should know about Tasigna?"
-- If you miss a dose, just take your next dose as scheduled. Do not make up for a missed dose.
-- If you take too much Tasigna, call your doctor or poison control center right away. Symptoms may include vomiting and drowsiness. During treatment with Tasigna your doctor will do tests to check for side effects and to see how well Tasigna is working for you. The tests will check your:
-- Heart
-- Blood cells (white blood cells, red blood cells, and platelets). Your blood cells should be checked every two weeks for the first two months and then monthly.
-- Electrolytes (potassium, magnesium)
-- Pancreas and liver function
-- Bone marrow samples
-- Your doctor may change your dose. Your doctor may have you stop Tasigna for some time or lower your dose if you have side effects with it.
What are the possible side effects of Tasigna?
Tasigna may cause serious side effects including:
-- See "What is the most important information I should know about Tasigna?"
-- Low blood counts. Low blood counts are common with Tasigna. Your doctor will check your blood counts regularly during treatment with Tasigna. Symptoms of low blood counts include:
-- Unexplained bleeding or bruising
-- Blood in urine or stool
-- Unexplained weakness
-- Liver damage. Symptoms include yellow skin and eyes.
-- Pancreas inflammation (pancreatitis). Symptoms include sudden stomach area pain with nausea and vomiting.
-- Bleeding in the brain: Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious.
The most common side effects of Tasigna include:
-- Low blood count
-- Rash
-- Nausea
-- Fever
-- Headache
-- Itching
-- Tiredness
-- Stomach (abdominal) pain
-- Diarrhea
-- Constipation
-- Muscle and joint pain
-- Back pain
-- Muscle spasms
-- Weakness
-- Hair loss
-- Runny or stuffy nose, sneezing, sore throat
-- Cough
About Gleevec
Gleevec® (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP). Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP after failure of interferon-alpha therapy.
Gleevec important safety information
Gleevec is often associated with edema and occasionally severe fluid retention. Patients should be weighed and monitored regularly for signs and symptoms of fluid retention, which can be serious or life-threatening.
Cytopenias have been reported. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months).
Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse reactions, or hematologic adverse reactions.
In Ph+ CML trials, severe (NCI Grades 3/4) lab abnormalities including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (Buy Fusidic Acid Without Prescription
The American Society of Hematology (ASH) annual meeting in Orlando, FL (December 4-7) will feature 30 oral presentations on Novartis Oncology compounds including Tasigna® (nilotinib) 150 mg capsules, Gleevec® (imatinib mesylate) tablets, Afinitor® (everolimus) tablets, Exjade® (deferasirox), Zometa® (zoledronic acid) and LBH589 (panobinostat)(1). The San Antonio Breast Cancer Symposium (SABCS), beginning December 8, will feature presentations on everolimus and Zometa(2).
"These data highlight progress of our hematology and oncology research with a focus on developing new treatment approaches based on an understanding of the molecular pathways involved in diseases," said Herve Hoppenot, President of Novartis Oncology. "Our goal is to bring the right treatment to the right patient across a broad range of cancers and rare diseases."
Key presentations at ASH include:
-- Tasigna - ENESTnd 24-month update comparing Tasigna to Gleevec in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (ASH Abstract #207; Dec. 6; 7:30 AM EST) (3).
-- Afinitor - Two studies showing activity of everolimus in mantle cell lymphoma (ASH Abstract #2803; Dec. 5; 6:00-8:00 PM EST)(4); (ASH Abstract #3963; Dec. 6; 6:00-8:00 PM EST)(5).
-- Exjade - EPIC sub-studies presenting three-year, end-of-study data on cardiac iron removal (ASH Abstract #4276; Dec. 6; 6:00-8:00 PM EST)(6) and post-hoc analysis from a large study reporting hematologic response in a cohort of MDS patients (ASH Abstract #2912; Dec. 5; 6:00-8:00 PM EST)(7); the first study (109E) to report on long-term safety and efficacy in sickle-cell disease patients up to five years (ASH Abstract #845; Dec. 6; 7:15 PM EST)(8); and the first large study (107E/108E) to assess effect of iron chelation therapy on liver pathology in large cohort of beta-thalassemia patients (ASH Abstract #4274; Dec. 6; 6:00-8:00 PM EST)(9).
-- Zometa - Phase III data evaluating Zometa in the treatment of patients with newly diagnosed multiple myeloma (ASH Abstract #311; Dec. 6; 8:00 AM EST)(10).
-- LBH589 (panobinostat) - Pivotal Phase II data for LBH589 in the treatment of Hodgkin lymphoma patients who relapse or are refractory after autologous stem cell transplant (ASH Abstract #419; Dec. 6; 11:30 AM EST)(11).
-- INC424 - Phase II data showing response rates to INC424 in patients with polycythemia vera (ASH Abstract #313; Dec. 6; 7:00 AM EST)(12); Phase II data of INC424 in patients with refractory leukemias including post-myeloproliferative disorder and acute myeloid leukemia (ASH Abstract #509; Dec. 6; 3:45 PM EST)(13).
-- PKC412 (midostaurin) - Phase II data evaluating midostaurin in the treatment of aggressive systemic mastocytosis (ASH Abstract #316; Dec. 6; 7:45 AM EST)(14).
-- HCD122 (lucatumumab) - Clinical activity evaluated in patients with relapsed/refractory Hodgkin or non-Hodgkin lymphoma treated in a Phase Ia/II trial (ASH Abstract #284; Dec. 6; 7:15 AM EST)(15).
Key presentations at SABCS include:
-- Afinitor - TAMRAD Phase II data on everolimus in the treatment of ER+/HER2- metastatic breast cancer after failure of aromatase inhibitors (SABCS Abstract #S1-6; Dec. 9; 10:30 AM CST)(16).
-- Zometa - Phase III data from the AZURE trial (BIG 01/04) of adjuvant treatment with Zometa in stage II/III breast cancer (SABCS Abstract #S4-5; Dec. 10; 4:15 PM CST)(17); Phase III data analyses from the ABCSG-12 trial evaluating the carry-over effect of Zometa in premenopausal women with early breast cancer after completion of therapy (SABCS Abstract #P5-11-02; Dec. 11; 5:30-7:30 PM CST)(18).
-- BEZ235 - Clinical data from a dose-escalation study with a special drug delivery system of BEZ235 in patients with metastatic/advanced solid tumors (SABCS Abstract #P6-15-07; Dec. 12, 7:00-8:30 PM CST)(19).
About Tasigna
Tasigna® (nilotinib) is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of Tasigna is based on major molecular response and cytogenetic response rates. The study is ongoing and further data will be required to determine long-term outcome.
Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Tasigna has been approved in more than 80 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including Gleevec. The effectiveness of Tasigna for this indication is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Tasigna important safety information
Tasigna can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death.
Your doctor should check the electrical activity of your heart with a test called an electrocardiogram (ECG):
-- Before starting Tasigna
-- 7 days after starting Tasigna
-- With any dose changes
-- Regularly during Tasigna treatment
You may lower your chances for having QTc prolongation with Tasigna if you:
Take Tasigna:
-- On an empty stomach. Do not take Tasigna with food.
-- At least 2 hours after eating any food, and
-- Wait at least 1 hour before eating any food
-- Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking Tasigna. Food and grapefruit products increase the amount of Tasigna in your body.
-- Avoid taking other medicines or supplements with Tasigna that can also cause QTc prolongation.
-- Tasigna can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.
-- Do not take any other medicine while taking Tasigna unless your doctor tells you it is okay to do so.
Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking Tasigna. These can be symptoms of QTc prolongation.
What is Tasigna?
Tasigna is a prescription medicine used to treat a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in adults who:
-- Are newly diagnosed, or
-- Are no longer benefiting from previous other treatments, including treatment with imatinib (Gleevec®), or
-- Have taken other treatments, including imatinib (Gleevec®), and cannot tolerate them
It is not known if Tasigna is safe or effective in children.
Who should not take Tasigna?
Do not take if you have:
-- Low levels of potassium or magnesium in your blood
-- Long QTc syndrome
What should I tell my doctor before starting Tasigna?
Tasigna may not be right for you. Before taking Tasigna, tell your doctor about all of your medical conditions, including if you have:
-- Heart problems
-- Irregular heartbeat
-- QTc prolongation or a family history of it
-- Liver problems
-- Had pancreatitis
-- Low blood levels of potassium or magnesium in your blood
-- A severe problem with lactose (milk sugar) or other sugars. The Tasigna capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take Tasigna.
-- Had a surgical procedure involving the removal of the entire stomach (total gastrectomy)
-- Are pregnant or plan to become pregnant. Tasigna may harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment with Tasigna. Talk to your doctor about the best birth control methods to prevent pregnancy while you are taking Tasigna.
-- Are breastfeeding or plan to breastfeed. It is not known if Tasigna passes into your breast milk. You and your doctor should decide if you will take Tasigna or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and non prescription medicines, vitamins and herbal supplements.
Tasigna can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects. See "What is the most important information I should know about Tasigna?"
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take Tasigna?
-- Take Tasigna exactly as your doctor tells you to take it. Do not change your dose or stop taking Tasigna unless your doctor tells you.
-- Tasigna is a long-term treatment.
-- Your doctor will tell you how many Tasigna capsules to take and when to take them.
-- Do not take Tasigna with food. Take Tasigna at least 2 hours after you eat and at least 1 hour before you eat.
-- Swallow Tasigna capsules whole with water. If you cannot swallow Tasigna capsules whole, tell your doctor.
-- Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract at any time during treatment. See "What is the most important information I should know about Tasigna?"
-- If you miss a dose, just take your next dose as scheduled. Do not make up for a missed dose.
-- If you take too much Tasigna, call your doctor or poison control center right away. Symptoms may include vomiting and drowsiness. During treatment with Tasigna your doctor will do tests to check for side effects and to see how well Tasigna is working for you. The tests will check your:
-- Heart
-- Blood cells (white blood cells, red blood cells, and platelets). Your blood cells should be checked every two weeks for the first two months and then monthly.
-- Electrolytes (potassium, magnesium)
-- Pancreas and liver function
-- Bone marrow samples
-- Your doctor may change your dose. Your doctor may have you stop Tasigna for some time or lower your dose if you have side effects with it.
What are the possible side effects of Tasigna?
Tasigna may cause serious side effects including:
-- See "What is the most important information I should know about Tasigna?"
-- Low blood counts. Low blood counts are common with Tasigna. Your doctor will check your blood counts regularly during treatment with Tasigna. Symptoms of low blood counts include:
-- Unexplained bleeding or bruising
-- Blood in urine or stool
-- Unexplained weakness
-- Liver damage. Symptoms include yellow skin and eyes.
-- Pancreas inflammation (pancreatitis). Symptoms include sudden stomach area pain with nausea and vomiting.
-- Bleeding in the brain: Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious.
The most common side effects of Tasigna include:
-- Low blood count
-- Rash
-- Nausea
-- Fever
-- Headache
-- Itching
-- Tiredness
-- Stomach (abdominal) pain
-- Diarrhea
-- Constipation
-- Muscle and joint pain
-- Back pain
-- Muscle spasms
-- Weakness
-- Hair loss
-- Runny or stuffy nose, sneezing, sore throat
-- Cough
About Gleevec
Gleevec® (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP). Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP after failure of interferon-alpha therapy.
Gleevec important safety information
Gleevec is often associated with edema and occasionally severe fluid retention. Patients should be weighed and monitored regularly for signs and symptoms of fluid retention, which can be serious or life-threatening.
Cytopenias have been reported. Complete blood counts should be performed weekly for the first month, biweekly for the second month, and periodically thereafter as clinically indicated (for example, every 2-3 months).
Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse reactions, or hematologic adverse reactions.
In Ph+ CML trials, severe (NCI Grades 3/4) lab abnormalities including neutropenia (3.6%-48%), anemia (1%-42%), thrombocytopenia (Buy Fusidic Acid Without Prescription
Pharmasset Reports Preliminary Results Of A 4-week Combination Study Of R7128 For The Treatment Of Chronic Hepatitis C
Pharmasset, Inc.
(Nasdaq: VRUS) announces the preliminary results of the third cohort of a
4-week Phase 1 clinical trial evaluating R7128 1000mg twice daily (BID) in
combination with the standard of care (SOC), Pegasys(R) (pegylated
interferon) plus Copegus(R) (ribavirin), in 31 treatment-naive patients
chronically infected with hepatitis C virus (HCV) genotype 1. R7128, a
prodrug of PSI-6130, is a nucleoside analogue polymerase inhibitor of HCV
that is being developed in collaboration with Roche.
As previously reported for Cohorts 1 and 2 of this study, R7128 has
demonstrated potent short-term antiviral activity and was generally safe
and well tolerated at doses of 500mg and 1500mg administered for 28 days in
combination with SOC. In Cohort 3, a new formulation of R7128 1000mg BID
was administered in combination with SOC. Of the 31 patients enrolled, 25
patients received R7128 1000mg BID and 6 received placebo. 88% (22 of 25)
patients receiving R7128 1000mg BID with SOC for 4 weeks achieved
undetectable HCV RNA levels (Buy Diflucan Without Prescription
(Nasdaq: VRUS) announces the preliminary results of the third cohort of a
4-week Phase 1 clinical trial evaluating R7128 1000mg twice daily (BID) in
combination with the standard of care (SOC), Pegasys(R) (pegylated
interferon) plus Copegus(R) (ribavirin), in 31 treatment-naive patients
chronically infected with hepatitis C virus (HCV) genotype 1. R7128, a
prodrug of PSI-6130, is a nucleoside analogue polymerase inhibitor of HCV
that is being developed in collaboration with Roche.
As previously reported for Cohorts 1 and 2 of this study, R7128 has
demonstrated potent short-term antiviral activity and was generally safe
and well tolerated at doses of 500mg and 1500mg administered for 28 days in
combination with SOC. In Cohort 3, a new formulation of R7128 1000mg BID
was administered in combination with SOC. Of the 31 patients enrolled, 25
patients received R7128 1000mg BID and 6 received placebo. 88% (22 of 25)
patients receiving R7128 1000mg BID with SOC for 4 weeks achieved
undetectable HCV RNA levels (Buy Diflucan Without Prescription
UnitedHealth Group To Provide Immediate Resources For Those Affected By The Southern California Wildfires
Due to the recent event of ongoing wildfires in Southern California, UnitedHealth Group (NYSE:UNH) and its family of companies, including UnitedHealthcare, Ovations, OptumHealth and Prescription Solutions, are taking the following immediate actions to help those affected by the fires.
Effective Nov. 16, 2008, through Nov. 30, 2008, UnitedHealth Group is temporarily allowing affected customers who are enrolled in its health plans and pharmacy benefit management (PBM) services to obtain early refills of their prescription medications if the customers have refills remaining on file at a retail network or mail order pharmacy. This exception also applies to individuals with prescription coverage through UnitedHealth Group Medicare Advantage, Medicare Supplement or Medicare Part D offerings, including AARP MedicareRx plans.
Customers who have been displaced or whose network facility is not accessible and require assistance or special accommodations due to the wildfires should call the number on the back of their medical ID cards. Customer care professionals are available to help customers who have been displaced from their place of residence locate an in-network health care provider for non-emergent services or assist them in obtaining out-of-network services when an in-network provider is not available.
OptumHealth Inc. is providing a free help line to people in Southern California coping with the emotional consequences of the recent wildfires. Staffed by experienced master's-level behavioral health specialists, the free help line offers assistance to callers seeking help in dealing with stress, anxiety and the grieving process. Callers may also receive referrals to a database of community resources to help them with specific concerns, such as financial and legal issues.
The toll-free help line number is 866-280-1418 and is available open 24 hours a day, seven days a week for as long as necessary. This service is free of charge. Resources and information are also available online in English at liveandworkwell and Spanish at mentesana-cuerposano.
About UnitedHealth Group
UnitedHealth Group is a diversified health and well-being company dedicated to making health care work better. Headquartered in Minneapolis, Minn., UnitedHealth Group offers a broad spectrum of products and services through six operating businesses: UnitedHealthcare, Ovations, AmeriChoice, OptumHealth, Ingenix and Prescription Solutions. Through its family of businesses, UnitedHealth Group serves more than 70 million individuals nationwide. Visit unitedhealthgroup for more information.
About OptumHealth
OptumHealth Inc. helps individuals navigate the health care system, finance their health care needs and achieve their health and well-being goals. The company's personalized health advocacy and engagement programs tap a unique combination of capabilities that encompass care solutions, behavioral solutions, specialty benefits and financial services. Serving more than 61 million people, OptumHealth is the nation's largest health and wellness business and is a UnitedHealth Group (NYSE:UNH) company.
OptumHealth
Buy Elimite Without Prescription
Effective Nov. 16, 2008, through Nov. 30, 2008, UnitedHealth Group is temporarily allowing affected customers who are enrolled in its health plans and pharmacy benefit management (PBM) services to obtain early refills of their prescription medications if the customers have refills remaining on file at a retail network or mail order pharmacy. This exception also applies to individuals with prescription coverage through UnitedHealth Group Medicare Advantage, Medicare Supplement or Medicare Part D offerings, including AARP MedicareRx plans.
Customers who have been displaced or whose network facility is not accessible and require assistance or special accommodations due to the wildfires should call the number on the back of their medical ID cards. Customer care professionals are available to help customers who have been displaced from their place of residence locate an in-network health care provider for non-emergent services or assist them in obtaining out-of-network services when an in-network provider is not available.
OptumHealth Inc. is providing a free help line to people in Southern California coping with the emotional consequences of the recent wildfires. Staffed by experienced master's-level behavioral health specialists, the free help line offers assistance to callers seeking help in dealing with stress, anxiety and the grieving process. Callers may also receive referrals to a database of community resources to help them with specific concerns, such as financial and legal issues.
The toll-free help line number is 866-280-1418 and is available open 24 hours a day, seven days a week for as long as necessary. This service is free of charge. Resources and information are also available online in English at liveandworkwell and Spanish at mentesana-cuerposano.
About UnitedHealth Group
UnitedHealth Group is a diversified health and well-being company dedicated to making health care work better. Headquartered in Minneapolis, Minn., UnitedHealth Group offers a broad spectrum of products and services through six operating businesses: UnitedHealthcare, Ovations, AmeriChoice, OptumHealth, Ingenix and Prescription Solutions. Through its family of businesses, UnitedHealth Group serves more than 70 million individuals nationwide. Visit unitedhealthgroup for more information.
About OptumHealth
OptumHealth Inc. helps individuals navigate the health care system, finance their health care needs and achieve their health and well-being goals. The company's personalized health advocacy and engagement programs tap a unique combination of capabilities that encompass care solutions, behavioral solutions, specialty benefits and financial services. Serving more than 61 million people, OptumHealth is the nation's largest health and wellness business and is a UnitedHealth Group (NYSE:UNH) company.
OptumHealth
Buy Elimite Without Prescription
SPRYCEL Receives CHMP Positive Opinion For The Treatment Of Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive CML In Chronic Phase
Bristol-Myers Squibb today announced that SPRYCEL (dasatinib) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive Chronic Myelogenous Leukaemia in Chronic Phase (CML-CP). This decision follows the presentation of results from the pivotal DASISION study in which dasatinib 100 mg once daily demonstrated a superior rate of confirmed complete cytogenetic response (CCyR)Complete cytogenetic response (CCyR) is defined as the absence of Philadelphia chromosome-positive metaphases on cytogenetic assessment of bone marrow cells. compared to imatinib by 12 months in chronic phase CML patients. The data was presented as a late-breaking abstract at the 46th Annual Meeting of the American Society of Clinical Oncology, during the Best Abstracts section of the Presidential Symposium at the 15th Congress of the EHA and published in New England Journal of Medicine in June 2010.
The European Medicines Agency's (EMA) CHMP adopted the positive opinion based on the 12 month results from the DASISION trial. The European Commission generally grants the Marketing Authorization within three months of a positive CHMP opinion.
Commenting on the developments BMS spokesperson Renzo Canetta, Vice-President, Oncology Global Clinical Research, said: "Bristol-Myers Squibb is committed to working together with regulatory authorities in different countries around the world to help ensure that CML patients and their physicians are provided with treatment options that can achieve optimal outcomes for their patients whether they are newly diagnosed or resistant or intolerant to previous treatment."
DASISION Study Results
In the ongoing DASISION (Dasatinib versus Imatinib Study in Treatment-NaГЇve CP-CML Patients) study, results of which were published in the NEJM in June 2010,1 77% of patients in the dasatinib arm vs. 66% of patients in the imatinib arm achieved confirmed CCyR (two consecutive assessments of CCyR) within 12 months (p=0.007). Additionally, 83% of dasatinib patients vs. 72% of imatinib patients achieved CCyR by one year (p=0.001). The time to CCyR was shorter for dasatinib patients than imatinib patients (hazard ratio = 1.5, pBuy Cystone Without Prescription
The European Medicines Agency's (EMA) CHMP adopted the positive opinion based on the 12 month results from the DASISION trial. The European Commission generally grants the Marketing Authorization within three months of a positive CHMP opinion.
Commenting on the developments BMS spokesperson Renzo Canetta, Vice-President, Oncology Global Clinical Research, said: "Bristol-Myers Squibb is committed to working together with regulatory authorities in different countries around the world to help ensure that CML patients and their physicians are provided with treatment options that can achieve optimal outcomes for their patients whether they are newly diagnosed or resistant or intolerant to previous treatment."
DASISION Study Results
In the ongoing DASISION (Dasatinib versus Imatinib Study in Treatment-NaГЇve CP-CML Patients) study, results of which were published in the NEJM in June 2010,1 77% of patients in the dasatinib arm vs. 66% of patients in the imatinib arm achieved confirmed CCyR (two consecutive assessments of CCyR) within 12 months (p=0.007). Additionally, 83% of dasatinib patients vs. 72% of imatinib patients achieved CCyR by one year (p=0.001). The time to CCyR was shorter for dasatinib patients than imatinib patients (hazard ratio = 1.5, pBuy Cystone Without Prescription
Detroit Free Press Opinion Pieces Debate Stupak Amendment
The Detroit Free Press on Thursday included two opposing opinion pieces regarding Rep. Bart Stupak's (D-Mich.) amendment to the House health reform bill (HR 3962). The amendment prohibits federally subsidized insurance plans from offering abortion services. The Senate recently rejected a similar amendment to its health reform bill (HR 3590). Summaries of the opinion pieces appear below.
Buy Epivir Without Prescription
~ Fern Ettinger, National Council of Jewish Women: The Stupak amendment "is an enormous step backward for those who believe in the separation of religion and state," Ettinger -- co-chair of public affairs for NCJW, greater Detroit section -- writes in a Free Press opinion piece. The amendment "favors one religious view of abortion and enlists the federal government to enforce it," Ettinger says, adding, "One religious belief system must not be imposed on all of us at the expense of public health." The provision of "affordable, accessible health care to all Americans is a moral imperative that unites Americans of many faith traditions," and the "selective withdrawal of critical health coverage from women is both a violation of this imperative and a betrayal of the public good," Ettinger continues. "The House would do well to follow the Senate's lead and support meaningful health reform that does not include a new sweeping coverage ban on abortion," Ettinger writes, concluding, "American families should have the opportunity to choose health coverage that reflects their own values and medical needs" (Ettinger, Detroit Free Press, 12/17).
~ Rep. Bart Stupak (D-Mich.): In a Free Press opinion piece, Stupak writes that despite claims by abortion-rights advocates that his amendment "goes beyond current law, no one has been able to show where the actual language in our amendment is different from language" in the Hyde Amendment. Stupak claims that under his amendment, individuals receiving federal subsidies to purchase insurance "will be prohibited from using them to pay for abortions or insurance policies that cover abortion." However, the amendment "does not prevent private plans from offering, or individuals from obtaining, abortion services with their own money," he argues, adding that the amendment "specifically states that those who receive federal subsidies can purchase a supplemental policy with private money to cover abortions." Stupak writes that insurance plans included in the Federal Employees Health Benefits Program are prohibited from offering abortion coverage to federal employees but are allowed to offer the coverage to nonfederal workers. "Given that insurance companies find it feasible, and profitable, to offer separate plans now, it is only logical that they would continue to do so on the health insurance exchange," Stupak argues (Stupak, Detroit Free Press, 12/17).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2009 The Advisory Board Company. All rights reserved.
Buy Epivir Without Prescription
Salmonella's Sweet Tooth Predicts Its Downfall
For the first time UK scientists have shown what the food poisoning bug Salmonella feeds on to survive as it causes infection: glucose.
Their discovery of Salmonella's weakness for sugar could provide a new way to vaccinate against it. The discovery could also lead to vaccine strains to protect against other disease-causing bacteria, including superbugs.
"This is the first time that anyone has identified the nutrients that sustain Salmonella while it is infecting a host's body," says Dr Arthur Thompson from the Institute of Food Research.
The nutrition of bacteria during infection is an emerging science. This is one of the first major breakthroughs, achieved in collaboration with Dr. Gary Rowley at the University of East Anglia.
Salmonella food poisoning causes infection in around 20 million people worldwide each year and is responsible for about 200,000 human deaths. It also infects farm animals and attaches to salad vegetables.
During infection, Salmonella bacteria are engulfed by immune cells designed to kill them. But instead the bacteria multiply.
Salmonella must acquire nutrients to replicate. The scientists focused on glycolysis, the process by which sugars are broken down to create chemical energy. They constructed Salmonella mutants unable to transport glucose into the immune cells they occupy and unable to use glucose as food. These mutant strains lost their ability to replicate within immune cells, rendering them harmless
"Our experiments showed that glucose is the major sugar used by Salmonella during infection," said Dr Thompson.
The mutant strains still stimulate the immune system, and the scientists have filed patents on them which could be used to develop vaccines to protect people and animals against poisoning by fully virulent Salmonella.
Glycolysis occurs in most organisms including other bacteria that occupy host cells. Disrupting how the bacteria metabolise glucose could therefore be used to create vaccine strains for other pathogenic bacteria, including superbugs.
The harmless strains could also be used as vaccine vectors. For example, the flu gene could be expressed within the harmless Salmonella strain and safely delivered to the immune system.
The next stage of the research will be to test whether the mutants elicit a protective immune response in mice.
In Germany the nutrition of bacteria is the subject of a six-year priority programme of research to investigate why bacteria are able to multiply inside a host's body to cause disease.
The IFR is an institute of the Biotechnology and Biological Sciences Research Council (BBSRC). This research was funded by a Core Strategic Grant from BBSRC.
Source:
Andrew Chapple
Norwich BioScience Institutes
Buy Metronidazole Gel Without Prescription
Their discovery of Salmonella's weakness for sugar could provide a new way to vaccinate against it. The discovery could also lead to vaccine strains to protect against other disease-causing bacteria, including superbugs.
"This is the first time that anyone has identified the nutrients that sustain Salmonella while it is infecting a host's body," says Dr Arthur Thompson from the Institute of Food Research.
The nutrition of bacteria during infection is an emerging science. This is one of the first major breakthroughs, achieved in collaboration with Dr. Gary Rowley at the University of East Anglia.
Salmonella food poisoning causes infection in around 20 million people worldwide each year and is responsible for about 200,000 human deaths. It also infects farm animals and attaches to salad vegetables.
During infection, Salmonella bacteria are engulfed by immune cells designed to kill them. But instead the bacteria multiply.
Salmonella must acquire nutrients to replicate. The scientists focused on glycolysis, the process by which sugars are broken down to create chemical energy. They constructed Salmonella mutants unable to transport glucose into the immune cells they occupy and unable to use glucose as food. These mutant strains lost their ability to replicate within immune cells, rendering them harmless
"Our experiments showed that glucose is the major sugar used by Salmonella during infection," said Dr Thompson.
The mutant strains still stimulate the immune system, and the scientists have filed patents on them which could be used to develop vaccines to protect people and animals against poisoning by fully virulent Salmonella.
Glycolysis occurs in most organisms including other bacteria that occupy host cells. Disrupting how the bacteria metabolise glucose could therefore be used to create vaccine strains for other pathogenic bacteria, including superbugs.
The harmless strains could also be used as vaccine vectors. For example, the flu gene could be expressed within the harmless Salmonella strain and safely delivered to the immune system.
The next stage of the research will be to test whether the mutants elicit a protective immune response in mice.
In Germany the nutrition of bacteria is the subject of a six-year priority programme of research to investigate why bacteria are able to multiply inside a host's body to cause disease.
The IFR is an institute of the Biotechnology and Biological Sciences Research Council (BBSRC). This research was funded by a Core Strategic Grant from BBSRC.
Source:
Andrew Chapple
Norwich BioScience Institutes
Buy Metronidazole Gel Without Prescription
More Kansas Insurers Offering Limited-Benefit Plans For Employer-Sponsored Health Care
Employer health insurance plans with limited or capped benefits and high deductibles -- sometimes called "mini-medical" plans -- are increasingly available to Kansas workers, the Wichita Eagle reports. Three of the largest health insurance companies in the Wichita area -- Preferred Health Systems, Blue Cross and Blue Shield of Kansas and CIGNA -- have either begun offering such plans this year or plan to offer them in 2007. "Industry experts say demand among employers is prompting [a] new emphasis on trimmed-down health benefits," the Eagle reports. One plan being offered by CIGNA HealthCare next year could save employers or their employees between 25% and 40% compared with traditional group insurance coverage. According to Eric Motter, a product and marketing manager for CIGNA's emerging markets, the plan will allow employers more flexibility in providing benefits to part-time or new employees. Brad Clothier, chief operating officer for PHS, said, "Everyone is looking to provide more affordable health care and services people see as a present-day benefit as well as a long-term gain," adding, "Insurers have got to be able to bring those types of programs to the table so the employer truly sees they've got some promise and hope down the road." BCBS spokesperson Graham Bailey said, "Employers, particularly small businesses, are operating on such a margin ... they can't offer something like health insurance to their employees." Bailey added, "The ability to offer health insurance is a great way to get good employees and keep them. It's important to be able to offer them something" (Atwater, Wichita Eagle, 11/2).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Buy Gentamicin Without Prescription
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Buy Gentamicin Without Prescription
Tsunami Warning Buoys - 10 Optimal Sites Found By Mathematical Model
Australian researchers describe a mathematical model in the International Journal of Operational Research that can find the ten optimal sites at which tsunami detection buoys and sea-level monitors should be installed. The model could save time and money in the installation of a detection system as well as providing warning for the maximum number of people should a potentially devastating tsunami occur again in the Indian Ocean.
A magnitude 9.3 shook the sea floor off the coast of Aceh, in northern Sumatra, Indonesia, on 26 December 2004. The quake led to an overwhelming tsunami with waves as high as 10.5 m travelling at up to 8 m per second. Within two hours the tsunami had reached Colombo, in Sri Lanka and then the east coast of India. Almost eight hours later, fishing villages on the east coast of Africa in Kenya and Somalia felt its impact. There was no warning for the people affected and almost a quarter of a million lives were lost across eleven nations fringing the Indian Ocean.
In 2005, the first steps to install a tsunami warning system in the Indian Ocean were being taken, with plans to deploy 24 tsunami detection buoys. The author of the study, Layna Groen and Lindsay Botten of the Department of Mathematical Sciences, at the University of Technology, and Katerina Blazek previously at Sinclair Knight Merz, in Sydney, NSW, Australia, suggest that their model has significant implications for the construction and maintenance of the tsunami warning system in the Indian Ocean.
The Intergovernmental Oceanographic Commission (IOC) of the United Nations Educational, Scientific and Cultural Organisation (UNESCO) planned the establishment of the Indian Ocean Tsunami Warning and Mitigation System (IOTWS). The detection/alert system is the crucial component consisting of seismic detectors, sea-level monitors and deep-sea pressure sensors attached to deep ocean buoys.
Groen and colleagues have focused on the latter two components as being critical to an adequate warning system. They point out that relatively few detection buoys are yet in place and a number of sea-level monitoring stations are still to be constructed. Their study, which uses the well-known modeling tool "Mathematica", should help the IOTWS decision makers in determining where the remaining buoys should be placed.
The team's analysis supports the positioning of the 40 proposed buoys, but points out that just 1o buoys would be adequate for warning the maximum number of people. They add that the same mathematical modeling approach could be applied to tsunami detection in the Atlantic Ocean, the Mediterranean, Caribbean, and Black Seas.
"The imperative for this is made clear in the UNESCO Intergovernmental Oceanographic Committee estimate that 'by the year 2025, three-quarters of the world's population will be living in coastal areas', and 'The expanded tsunami network that the Intergovernmental Oceanographic Commission of UNESCO is coordinating is just the first step in building a global tsunami warning system designed to monitor oceans and seas everywhere'."
"Optimizing the location of tsunami detection buoys and sea-level monitors in the Indian Ocean" in Int. J. Operational Research, 2010, 8, 174-188
Source:
Layna Groen
Inderscience Publishers
Buy Pyridium Without Prescription
A magnitude 9.3 shook the sea floor off the coast of Aceh, in northern Sumatra, Indonesia, on 26 December 2004. The quake led to an overwhelming tsunami with waves as high as 10.5 m travelling at up to 8 m per second. Within two hours the tsunami had reached Colombo, in Sri Lanka and then the east coast of India. Almost eight hours later, fishing villages on the east coast of Africa in Kenya and Somalia felt its impact. There was no warning for the people affected and almost a quarter of a million lives were lost across eleven nations fringing the Indian Ocean.
In 2005, the first steps to install a tsunami warning system in the Indian Ocean were being taken, with plans to deploy 24 tsunami detection buoys. The author of the study, Layna Groen and Lindsay Botten of the Department of Mathematical Sciences, at the University of Technology, and Katerina Blazek previously at Sinclair Knight Merz, in Sydney, NSW, Australia, suggest that their model has significant implications for the construction and maintenance of the tsunami warning system in the Indian Ocean.
The Intergovernmental Oceanographic Commission (IOC) of the United Nations Educational, Scientific and Cultural Organisation (UNESCO) planned the establishment of the Indian Ocean Tsunami Warning and Mitigation System (IOTWS). The detection/alert system is the crucial component consisting of seismic detectors, sea-level monitors and deep-sea pressure sensors attached to deep ocean buoys.
Groen and colleagues have focused on the latter two components as being critical to an adequate warning system. They point out that relatively few detection buoys are yet in place and a number of sea-level monitoring stations are still to be constructed. Their study, which uses the well-known modeling tool "Mathematica", should help the IOTWS decision makers in determining where the remaining buoys should be placed.
The team's analysis supports the positioning of the 40 proposed buoys, but points out that just 1o buoys would be adequate for warning the maximum number of people. They add that the same mathematical modeling approach could be applied to tsunami detection in the Atlantic Ocean, the Mediterranean, Caribbean, and Black Seas.
"The imperative for this is made clear in the UNESCO Intergovernmental Oceanographic Committee estimate that 'by the year 2025, three-quarters of the world's population will be living in coastal areas', and 'The expanded tsunami network that the Intergovernmental Oceanographic Commission of UNESCO is coordinating is just the first step in building a global tsunami warning system designed to monitor oceans and seas everywhere'."
"Optimizing the location of tsunami detection buoys and sea-level monitors in the Indian Ocean" in Int. J. Operational Research, 2010, 8, 174-188
Source:
Layna Groen
Inderscience Publishers
Buy Pyridium Without Prescription
Geron Initiates Clinical Trial Of GRN163L In Combination With Bortezomib And Dexamethasone In Patients With Multiple Myeloma
Geron Corporation (Nasdaq:GERN) today announced that it has enrolled the first multiple myeloma patient in a clinical trial of its telomerase inhibitor drug, GRN163L, in combination with other treatments.
The primary objective of the Phase I dose escalation study is to determine the safety, maximum tolerated dose (MTD) and objective response rate of GRN163L when administered intravenously in combination with bortezomib (Velcade®) with and without dexamethasone in patients with relapsed or refractory disease.
"There is a need for novel therapies in the treatment of multiple myeloma," said William Bensinger, M.D. of the Fred Hutchinson Cancer Research Center, a principal investigator for the trial. "GRN163L has shown synergistic effects in combination with bortezomib in preclinical models of multiple myeloma, so we are very interested in assessing this treatment regimen in patients."
This is the second trial to be conducted of GRN163L in multiple myeloma. A Phase I single agent study initiated is ongoing.
"We are pleased to reach this milestone in the clinical development of our lead anti-cancer drug," said Fabio Benedetti, M.D., Geron's chief medical officer, oncology. "We have been able to draw on our experience to date with GRN163L from our ongoing single agent studies, including in multiple myeloma, for critical aspects of the design of this combination trial. Our clinical program for this drug now includes six active trials evaluating GRN163L as either a single agent or in combination with current treatment regimens."
Preclinical studies have also demonstrated that GRN163L can inhibit clonogenic growth of both primary myeloma patient samples and subpopulations from myeloma cell lines enriched for cancer stem cells. These subpopulations show resistance to several conventional agents, including bortezomib. Cancer stem cells capable of clonogenic growth may play an important role in rapid regrowth of tumors after initial reduction by standard treatments.
About Multiple Myeloma
Multiple myeloma is a malignancy of plasma cells, which are antibody-producing cells of the immune system. Multiple myeloma usually arises in the bone marrow and is characterized by interference with the production of blood cells, destructive lesions of bone that can cause debilitating fractures, and excessive production of antibody molecules. These abnormal molecules may interfere with the function of many tissues and organs in addition to bone marrow, including the kidneys. Multiple myeloma is the second most common hematological malignancy of adults.
The American Cancer Society has projected that 19,900 new cases and 10,790 deaths due to multiple myeloma will have occurred in the United States by the end of this year. Although the number of treatment options for multiple myeloma has increased in recent years, the vast majority of multiple myeloma patients progress or recur after initial therapy and ultimately die from the disease.
Bortezomib (Velcade®) is a proteasome inhibitor drug that is a current standard treatment for refractory or relapsing multiple myeloma. Dexamethasone is a glucocorticosteriod often given with bortezomib in the treatment of myeloma.
About Telomerase and GRN163L
Telomerase is a critical and potentially broadly applicable tumor target. The enzyme is expressed in a wide range of malignant tumors, and its activity is essential for the indefinite replicative capacity of cancer cells that enables their malignant cell growth. Telomerase is absent or expressed only transiently at low levels in most normal adult tissues.
GRN163L is a short chain oligonucleotide that binds with high affinity and specificity to the catalytic site of telomerase, resulting in competitive inhibition of enzyme activity. Proprietary manufacturing chemistry and the addition of a 5' lipid chain have enabled the molecule to penetrate cells and tissues throughout the body.
GRN163L has demonstrated anti-tumor effects in a wide range of preclinical hematological and solid tumor models, including multiple myeloma.
About Geron
Geron is a biopharmaceutical company that is developing first-in-class therapeutic products for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The products are based on our core expertise in telomerase and human embryonic stem cells. For more information, visit geron.
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding potential applications of Geron's telomerase technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron's periodic reports, including the quarterly report on Form 10-Q for the quarter ended June 30, 2008.
Source
Anna Krassowska
Geron Corporation
View drug information on Velcade.
Buy Stavudine Without Prescription
The primary objective of the Phase I dose escalation study is to determine the safety, maximum tolerated dose (MTD) and objective response rate of GRN163L when administered intravenously in combination with bortezomib (Velcade®) with and without dexamethasone in patients with relapsed or refractory disease.
"There is a need for novel therapies in the treatment of multiple myeloma," said William Bensinger, M.D. of the Fred Hutchinson Cancer Research Center, a principal investigator for the trial. "GRN163L has shown synergistic effects in combination with bortezomib in preclinical models of multiple myeloma, so we are very interested in assessing this treatment regimen in patients."
This is the second trial to be conducted of GRN163L in multiple myeloma. A Phase I single agent study initiated is ongoing.
"We are pleased to reach this milestone in the clinical development of our lead anti-cancer drug," said Fabio Benedetti, M.D., Geron's chief medical officer, oncology. "We have been able to draw on our experience to date with GRN163L from our ongoing single agent studies, including in multiple myeloma, for critical aspects of the design of this combination trial. Our clinical program for this drug now includes six active trials evaluating GRN163L as either a single agent or in combination with current treatment regimens."
Preclinical studies have also demonstrated that GRN163L can inhibit clonogenic growth of both primary myeloma patient samples and subpopulations from myeloma cell lines enriched for cancer stem cells. These subpopulations show resistance to several conventional agents, including bortezomib. Cancer stem cells capable of clonogenic growth may play an important role in rapid regrowth of tumors after initial reduction by standard treatments.
About Multiple Myeloma
Multiple myeloma is a malignancy of plasma cells, which are antibody-producing cells of the immune system. Multiple myeloma usually arises in the bone marrow and is characterized by interference with the production of blood cells, destructive lesions of bone that can cause debilitating fractures, and excessive production of antibody molecules. These abnormal molecules may interfere with the function of many tissues and organs in addition to bone marrow, including the kidneys. Multiple myeloma is the second most common hematological malignancy of adults.
The American Cancer Society has projected that 19,900 new cases and 10,790 deaths due to multiple myeloma will have occurred in the United States by the end of this year. Although the number of treatment options for multiple myeloma has increased in recent years, the vast majority of multiple myeloma patients progress or recur after initial therapy and ultimately die from the disease.
Bortezomib (Velcade®) is a proteasome inhibitor drug that is a current standard treatment for refractory or relapsing multiple myeloma. Dexamethasone is a glucocorticosteriod often given with bortezomib in the treatment of myeloma.
About Telomerase and GRN163L
Telomerase is a critical and potentially broadly applicable tumor target. The enzyme is expressed in a wide range of malignant tumors, and its activity is essential for the indefinite replicative capacity of cancer cells that enables their malignant cell growth. Telomerase is absent or expressed only transiently at low levels in most normal adult tissues.
GRN163L is a short chain oligonucleotide that binds with high affinity and specificity to the catalytic site of telomerase, resulting in competitive inhibition of enzyme activity. Proprietary manufacturing chemistry and the addition of a 5' lipid chain have enabled the molecule to penetrate cells and tissues throughout the body.
GRN163L has demonstrated anti-tumor effects in a wide range of preclinical hematological and solid tumor models, including multiple myeloma.
About Geron
Geron is a biopharmaceutical company that is developing first-in-class therapeutic products for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The products are based on our core expertise in telomerase and human embryonic stem cells. For more information, visit geron.
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press release regarding potential applications of Geron's telomerase technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron's periodic reports, including the quarterly report on Form 10-Q for the quarter ended June 30, 2008.
Source
Anna Krassowska
Geron Corporation
View drug information on Velcade.
Buy Stavudine Without Prescription
Подписаться на:
Комментарии (Atom)