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
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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
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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
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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
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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
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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.
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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.
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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
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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
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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
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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.
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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.
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