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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