Vion Pharmaceuticals Announces Initiation of Clinical Trial of Cloretazine(R) (VNP40101M) in Combination with ... ( NEW HAVEN Conn. May 8 /- VION PHA...)

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Vion Pharmaceuticals Announces Initiation of Clinical Trial of Cloretazine(R) (VNP40101M) in Combination with Cytarabine

Date:5/8/2008

NEW HAVEN, Conn., May 8 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION) today announced the start of an investigator-sponsored Phase I/II clinical trial of its lead anticancer agent Cloretazine(R) (VNP40101M) in combination with cytarabine in elderly patients with previously untreated acute myelogenous leukemia (AML) and high-risk myelodysplastic syndromes (MDS). The trial is being conducted under the direction of Ellen K. Ritchie, M.D. at The Weill-Cornell Medical College in New York City. Co- investigators for the study are Eric Feldman, M.D. and Gail Roboz, M.D.

The objectives of the trial are: (i) to define the maximum tolerated dose (MTD) of Cloretazine(R) (VNP40101M) when given in combination with cytarabine to AML and high-risk MDS patients over the age of 60, and (ii) to evaluate this combination further for safety and efficacy in a larger cohort of patients. Cloretazine(R) (VNP40101M) will be given as a 30 - 60 minute infusion on day 1 approximately 3-4 hours after the start of the cytarabine infusion. Cytarabine will be administered as a continuous infusion of 100 mg/m2/day for 7 days. In the Phase I portion of the study, dose escalation will be done in cohorts of at least 3 patients and the maximum tolerated dose (MTD) identified in the Phase I segment will be used in the Phase II segment of the study.

Ann Cahill, Vice President, Clinical Development, commented, "It is important for us to continue to study Cloretazine(R) (VNP40101M) in combination with different doses and schedules of cytarabine, the most widely used drug in the treatment of AML. In addition, we want to evaluate Cloretazine(R) (VNP40101M) in a broader group of elderly patients than are currently being studied in our pivotal tri
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SOURCE Vion Pharmaceuticals, Inc.
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Vion Pharmaceuticals Announces Initiation of Clinical Trial of Cloretazine(R) (VNP40101M) in Combination with ...( NEW HAVEN Conn. May 8 /- VION PHA...),Health