Vion
Pharmaceuticals, Inc. (Nasdaq: VION) today announced that it had accrued
210 patients to the Phase III trial of its lead anticancer agent
Cloretazine(R) (VNP40101M). The trial is evaluating
Cloretazine(R)(VNP40101M) in combination with cytarabine for the treatment
of relapsed acute myelogenous leukemia (AML).
The protocol for this international Phase III randomized study includes
a planned interim analysis on the first 210 patients. With the time
required for treating and following these patients for a response
assessment, the Company believes that these data should be available for
review by the Data Safety Monitoring Board for the trial in March or April
of 2007.
The trial is designed to accrue 420 patients if it continues to full
accrual. The Company believes that full accrual to the trial can be
completed by late 2007 or early 2008.
Ann Cahill, Vice President, Clinical Development of Vion said, "We are
proud to have reached the halfway point of accrual to our Phase III trial
of Cloretazine(R)(VNP40101M). Together with our pivotal Phase II trial of
Cloretazine(R)(VNP40101M) as a single agent in elderly patients with de
novo poor-risk AML, our Phase III trial represents an important evaluation
of Cloretazine(R)(VNP40101M)'s role in the treatment of AML, a
life-threatening disease for many people."
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: (i) a Phase III trial in combination with cytarabine in
relapsed acute myelogenous leukemia and (ii) a Phase II pivotal trial as a
single agent in elderly patients with previously untreated de novo
poor-risk acute myelogenous leukemia. Additional trials of
Cloretazine(R)(VNP40101M) as a single agent in pediatric brain tumors,
small cell lung cancer, and in combination with temozolomide in hematologic
malignancies, are 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. 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 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, 2005. 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/