NEW HAVEN, Conn., Aug. 15 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION) today announced that it had accrued a total of 85 patients to the pivotal Phase II trial of its lead anticancer agent Cloretazine(R) (VNP40101M) in previously untreated elderly patients with de novo poor-risk acute myelogenous leukemia (AML).
Alan Kessman, Chief Executive Officer said, "We are extremely pleased to have reached this milestone in the pivotal Phase II trial of our lead anticancer agent. We will now proceed to analyze the data and, if warranted, prepare a New Drug Application for submission to the U.S. Food and Drug Administration in 2008." He added, "We continue to plan on the release of preliminary data from this trial at the American Society of Hematology (ASH) Meeting in December."
The pivotal Phase II trial, initiated in May 2006, is evaluating Cloretazine(R) (VNP40101M) as a single agent in previously untreated AML patients over the age of 60 with de novo poor-risk AML. Patients are eligible for this trial if they are at least 60 years of age with de novo AML and have one of the following additional risk factors: (i) unfavorable cytogenetics; (ii) an ECOG performance status of 2 or greater; or (iii) a co-morbid condition that precludes them from receiving cytotoxic therapy with cytarabine and an anthracycline. Patients over the age of 70 with de novo AML who do not have favorable cytogenetics are also eligible.
The primary endpoint for this trial is the complete response rate (including complete remission (CR) and complete remission with incomplete platelet recovery (CRp)). Secondary endpoints include overall survival, disease-free survival and progression-free survival.
The trial ha
|SOURCE Vion Pharmaceuticals, Inc.|
Copyright©2007 PR Newswire.