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Phase 3 Trial of Cloretazine in Relapsed Acute Myelogenous Leukemia Initiated
Susan O'Brien, MD, Professor of Medicine in the Department of Leukemia, and principal investigator for the trial at MD Anderson Cancer Center commented, "The therapeutic options for patients with relapsed acute myelogenous leukemia are limited and unsatisfactory. Given emerging evidence of CLORETAZINE(TM) (VNP40101M)'s anti-leukemia activity, MD Anderson is pleased to be the lead institution for this global Phase III clinical trial."
"Encouraging CLORETAZINE(TM) (VNP40101M) results in early phase trials have also provided important leads in other malignancies," said Frank Giles, MD, Chief, Section Developmental Therapeutics, Department of Leukemia, University of Texas, MD Anderson Cancer Center. "The launch of a pivotal Phase III trial is an important milestone in the development of any drug; it is especially gratifying to see an AML investigational agent go to Phase III so rapidly" said Giles.
Alan Kessman, Chief Executive Officer, stated "We are proud of our continued progress in the development program for CLORETAZINE(TM) (VNP40101M). We consider the start of this pivotal trial as a major milestone accomplishment for Vion. We are hopeful that the Phase III trial will prove CLORETAZINE(TM) (VNP40101M)'s potential to bring a new treatment to patients in first relapse AML, which is currently an unmet medical need."
Vion recently reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this trial. The trial is a double-blind, placebo-controlled randomized evaluation of an experimental treatment consisting of Ara-C plus CLORETAZINE(TM) (VNP40101M) versus a control arm regimen of Ara-C and placebo. This trial is designed to accrue patients in first relapse whose first complete remission (CR) was more than three months but less than twenty-four months in duration. Patients will be stratified according to: (i) age, greater than or less than 60 years and (ii) length of the first CR, more than or less than 12 months in duration.
The primary endpoint for the trial is the objective response rate, defined as CR plus CRp (a complete remission with incomplete recovery of the platelet count). Secondary endpoints include time to progression, duration of response, overall survival and toxicity. An interim analysis is planned.
Source: Vion Pharmaceuticals