Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in E...(d a two-stage min-max design in which if...),Health

Date:8/19/2007

d a two-stage min-max design in which if there were at least nine responses in the first 42 patients, the trial was to continue to the second stage. On January 25, 2007, the Company announced that there had been at least nine remissions in the first stage and that the trial would therefore continue. Eighty-five patients were enrolled in order to ensure that at least 77 would be eligible for the trial and included in the full analysis set. At least 22 responses in 77 patients are required to confirm the 35% target response rate with 95% confidence. If the full analysis set includes all 85 patients, then at least 24 responses are required for confirmation of the target response rate.

Dr. Dan DeAngelo, Assistant Professor at Harvard Medical School and the Dana Farber Cancer Institute and an investigator on the trial commented, "The treatment of elderly patients with poor-risk AML represents a significant unmet medical need in clinical oncology, and it is important that we find new effective treatment options. Agents such as Cloretazine(R) (VNP40101M) have the potential to address this need."

Dr. Gary Schiller, Professor of Medicine at the UCLA Geffen School of Medicine and an investigator on the trial added, "This was a very important study for older AML patients treated here at UCLA. As a single agent therapy administered over 30 to 60 minutes, Cloretazine(R) (VNP40101M) is clearly an active agent with the potential to play an important role in the treatment of this difficult population."

On August 8, 2007, the Company announced that certain sites on the trial would remain open and continue to accrue patients to an ECG sub-study. Recent FDA/ICH guidance recommends that an electrocardiographic evaluation (QT/QTc) study be included in the clinical development of all new drugs. Normally these studies are conducted in healthy subjects so that disease factors/co- morbidities do not confound the results. As Cloretazine(R) (VNP40101M) is a cytotoxic agent w
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SOURCE Vion Pharmaceuticals, Inc. Copyright©2007 PR Newswire.

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