Vion Initiates Phase III Trial of CLORETAZINE(TM) (VNP40101M) In Relapsed Acute Myelogenous Leukemia

Posted by rob on March 28, 2005 under Uncategorized | Be the First to Comment

NEW HAVEN, Conn., March 28 /PRNewswire-FirstCall/ — VION PHARMACEUTICALS,
INC. (Nasdaq: VION) announced today that it commenced dosing the first patient
on the Phase III pivotal trial of its anticancer agent CLORETAZINE(TM)
(VNP40101M) in relapsed acute myelogenous leukemia (AML).
    Susan O’Brien, MD, Professor of Medicine in the Department of Leukemia,
and principal investigator for the trial at MD Anderson Cancer Center
commented, “The therapeutic options for patients with relapsed acute
myelogenous leukemia are limited and unsatisfactory.  Given emerging evidence
of CLORETAZINE(TM) (VNP40101M)’s anti-leukemia activity, MD Anderson is
pleased to be the lead institution for this global Phase III clinical trial.”
    “Encouraging CLORETAZINE(TM) (VNP40101M) results in early phase trials
have also provided important leads in other malignancies,” said Frank Giles,
MD, Chief, Section Developmental Therapeutics, Department of Leukemia,
University of Texas, MD Anderson Cancer Center.  “The launch of a pivotal
Phase III trial is an important milestone in the development of any drug; it
is especially gratifying to see an AML investigational agent go to Phase III
so rapidly” said Giles.
    Alan Kessman, Chief Executive Officer, stated “We are proud of our
continued progress in the development program for CLORETAZINE(TM) (VNP40101M).
We consider the start of this pivotal trial as a major milestone
accomplishment for Vion.  We are hopeful that the Phase III trial will prove
CLORETAZINE(TM) (VNP40101M)’s potential to bring a new treatment to patients
in first relapse AML, which is currently an unmet medical need.”
    Vion recently reached agreement with the U.S. Food and Drug Administration
(FDA) on a Special Protocol Assessment (SPA) for this trial. The trial is a
double-blind, placebo-controlled randomized evaluation of an experimental
treatment consisting of Ara-C plus CLORETAZINE(TM) (VNP40101M) versus a
control arm regimen of Ara-C and placebo.  This trial is designed to accrue
patients in first relapse whose first complete remission (CR) was more than
three months but less than twenty-four months in duration.  Patients will be
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 the platelet
count). Secondary endpoints include time to progression, duration of response,
overall survival and toxicity. An interim analysis is planned.

    Vion Pharmaceuticals, Inc. is developing novel agents for the treatment of
cancer.  Vion has two agents in clinical trials:  CLORETAZINE(TM) (VNP40101M),
a unique sulfonylhydrazine alkylating agent, and Triapine(R), a potent
inhibitor of a key step in DNA synthesis.  In preclinical studies, Vion is
also evaluating KS119, a hypoxia-selective compound from the sulfonylhydrazine
class, and heterocyclic hydrazones.   For additional information on Vion and
its product development programs, visit the Company’s Internet web site at
http://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 ability to secure
external sources of funding to continue its operations, the inability to
access capital and funding on favorable terms, continued operating losses and
the inability to continue operations as a result, its dependence on regulatory
approval for its products, delayed or unfavorable results of drug trials, the
possibility that favorable results of earlier clinical trials are not
predictive of safety and efficacy results in later clinical trials, the need
for additional research and testing, 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 discussed in Vion’s Annual
Report on Form 10-K for the year ended December 31, 2004. 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
                       (203) 498-4210 phone

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