Vion Pharmaceuticals Announces Presentation of Data from Phase III Trial of Cloretazine(R) (VNP40101M) and Cytarabine in Relapsed Acute Myelogenous Leukemia at the ASCO(R) Annu...( NEW HAVEN Conn. June 2 /- VIONPHA...),Health

NEW HAVEN, Conn., June 2 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION) today announced that data from the Phase III trial of its lead anticancer agent Cloretazine(R) (VNP40101M) in combination with cytarabine in patients with first relapse of acute myelogenous leukemia (AML) had been presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO(R)) in Chicago, Illinois.

The Phase III trial started in March 2005 and was conducted in 69 sites in North America and Europe. In May 2007, after an interim analysis of 210 patients by the trial's data safety monitoring board (DSMB), the Company suspended treatment and enrollment of patients, and the U.S. Food and Drug Administration (FDA) placed the trial on clinical hold, due to increased mortality in the cytarabine plus Cloretazine(R) (VNP40101M) treatment arm of the study, as compared to the cytarabine plus placebo control arm. In January 2008, the Company announced that the FDA had lifted the clinical hold and that a new trial with a lower dose of Cloretazine(R) (VNP40101M) in combination with cytarabine and increased supportive care measures could be pursued in the future.

The objective response rate of the cytarabine and Cloretazine(R) (VNP40101M) treatment arm of the trial was 37% versus 19% for the control arm. The median response duration was 11.2 months on the treatment arm versus 8.1 months on the control arm. Overall survival was 4.2 months on the treatment arm versus 6 months on the control arm.

The Company reported that on-study mortality (deaths from all causes in less than or equal to 30 days or from adverse events in less than or equal to 60 days from any treatment cycle) was 39% for the cytarabine and Cloretazin
'/>"/>