Published:
Vion Pharmaceuticals Announces Presentation of Interim Data from Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Acute Myelogenous Leukemia at the ASCO(R) Annual Meeting
NEW HAVEN, Conn., June 2 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS,
INC. (Nasdaq: VION) today announced that interim data from the pivotal Phase
II trial of its lead anticancer agent Cloretazine(R) (VNP40101M) in elderly
patients with de novo poor-risk acute myelogenous leukemia (AML) had been
presented at the 44th Annual Meeting of the American Society of Clinical
Oncology (ASCO(R)) inChicago, Illinois.
At ASCO(R), data were presented in 85 evaluable patients. The median age
of these patients was 73 years (range of 60-87 years). Ninety-five percent of
patients had two or more risk factors associated with a poor prognosis in
elderly AML and 74% had three or more risk factors. The most common risk
factors were age greater than or equal to 70 (78% of patients), and cardiac
and pulmonary dysfunction (73% and 76% of patients respectively). In
addition, 47% of patients had unfavorable cytogenetics.
The overall complete response rate was 35% (22 CR and 8 CRp). 90% of
responses occurred after first induction treatment. While follow-up is still
ongoing, the median (range) of overall survival for responders was 6.3 months
(1.7-16.4 months) and for all patients was 3.2 months (0.1-16.4 months).
The induction death rate within 30 days of first induction treatment was
14%. The majority of first induction deaths were either due to progression of
disease or infection. Myelosuppression was the primary toxicity, with
pneumonia, infection and sepsis and non-infectious pulmonary disorders
(hypoxia and dyspnea) being the most common severe adverse events (greater
than or equal to grade 3).
Dr. Gary Schiller, Professor of Medicine at the David Geffen School of
Medicine at UCLA and a lead investigator on the study, said "The responses
observed in this trial represent a clinically meaningful outcome for many of
these difficult-to-treat AML patients. As a single-agent, single-infusion
therapy, Cloretazine(R) (VNP40101M) has the potential to be an important new
treatment option for older patients with poor-risk AML."
Alan Kessman, Chief Executive Officer, said, "These interim data continue
to demonstrate Cloretazine(R) (VNP40101M)'s potential utility in a patient
population which represents an unmet medical need." He added, "It continues
to be our plan to file a new drug application with the U.S. Food and Drug
Administration in 2008 based on the data from this trial and our previous
Phase II trial in elderly patients with AML."
The pivotal Phase II trial started in May 2006 and was conducted in 25
sites inNorth America andEurope. Enrollment of the primary study was
completed in August 2007. The trial remains open at selected sites in order to
collect QT/QTc interval data in an electrocardiogram sub-study in accordance
with FDA/ICH guidelines.
The study was designed for patients with untreated de novo AML who are age
60 or older and have at least one of the following adverse prognostic factors:
age greater or equal to 70, ECOG performance status equal to 2, unfavorable
cytogenetics or organ dysfunction. The primary endpoint of the trial is the
overall complete response rate measured as either complete remission (CR) or
CRp, a complete response with incomplete platelet recovery. Secondary
endpoints are progression-free survival, leukemia-free survival, overall
survival and the toxicity of Cloretazine(R) (VNP40101M) in this patient
population.
Patients receive induction therapy of 600 mg/m2 of Cloretazine(R)
(VNP40101M) in a sixty-minute infusion. Second induction is permitted between
days 35 and 60 in patients with bone marrow improvement but residual disease.
Patients who respond can receive consolidation therapy with a continuous
infusion of 400 mg/m2 of cytarabine for five days.
Preliminary data for this trial were previously announced at the American
Society of Hematology Annual Meeting in December 2007.
About Vion
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. Clinical trials of Cloretazine(R) (VNP40101M) with cytarabine in
elderly patients with acute myelogenous leukemia, with temozolomide in brain
tumors, and with stem cell transplantation in advanced hematologic
malignancies, are also being conducted. Triapine(R), a potent inhibitor of a
key step in DNA synthesis, is being evaluated in clinical trials sponsored by
the National Cancer Institute. For additional information on Vion and its
product development programs, visit the Company's Internet web site at
www.vionpharm.com.
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, particularly Cloretazine(R)
(VNP40101M), delayed or unfavorable results of drug trials, the possibility
that favorable results of earlier preclinical studies, clinical trials or
interim clinical trial data are not predictive of safety and efficacy results
in later or final clinical trials, the need for additional research and
testing, the inability to manufacture product, 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, the possible delisting of
the Company's common stock from the NASDAQ Capital Market 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 Form 10-K for the year ended December 31, 2007 and Form 10-Q for the
quarter ended March 31, 2008. In particular, there can be no assurance as to
the results of any of the Vion'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.
COMPANY CONTACT: Vion Pharmaceuticals, Inc.
Alan Kessman, Chief Executive Officer
Howard B. Johnson, President & CFO
(203) 498-4210
SOURCE Vion Pharmaceuticals, Inc.
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Copyright © 2009, NewsBlaze,
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