Vion Pharmaceuticals Announces Presentation of Interim Data from Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Acute Myelogenous Leukemia at the ASCO(R) Annu...(responsesobserved in this trial represen...),Health

Alan Kessman, Chief Executive Officer, said, "These interim data continue to demonstrate Cloretazine(R) (VNP40101M)'s potential utility in a patient population which represents an unmet medical need." He added, "It continues to be our plan to file a new drug application with the U.S. Food and Drug Administration in 2008 based on the data from this trial and our previous Phase II trial in elderly patients with AML."

The pivotal Phase II trial started in May 2006 and was conducted in 25 sites in North America and Europe. Enrollment of the primary study was completed in August 2007. The trial remains open at selected sites in order to collect QT/QTc interval data in an electrocardiogram sub-study in accordance with FDA/ICH guidelines.

The study was designed for patients with untreated de novo AML who are age 60 or older and have at least one of the following adverse prognostic factors: age greater or equal to 70, ECOG performance status equal to 2, unfavorable cytogenetics or organ dysfunction. The primary endpoint of the trial is the overall complete response rate measured as either complete remission (CR) or CRp, a complete response with incomplete platelet recovery. Secondary endpoints are progression-free survival, leukemia-free survival, overall survival and the toxicity of Cloretazine(R) (VNP40101M) in this patient population.

Patients receive induction therapy of 600 mg/m2 of Cloretazine(R) (VNP40101M) in a sixty-minute infusion. Second induction is permitted between days 35 and 60 in patients with bone marrow improvement but residual disease. Patients who respond can receive consolidation therapy with a continuous infusion of 400 mg/m2 of cytar
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