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Biotech / Medical : Vion (formerly Oncorx) interesting play on Gene Therapy -- Ignore unavailable to you. Want to Upgrade?

To: Jim Oravetz who wrote (345)	8/15/2007 1:51:00 PM
From: Jim Oravetz	Read Replies (1) \| Respond to of 370

Vion Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML August 15, 2007 8:00 a.m. NEW HAVEN, Conn., Aug. 15 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, 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 had a two-stage min-max design in which if there were at least nine responses in the first 42 patients, the trial was to continue to the second stage. On January 25, 2007, the Company announced that there had been at least nine remissions in the first stage and that the trial would therefore continue. Eighty-five patients were enrolled in order to ensure that at least 77 would be eligible for the trial and included in the full analysis set. At least 22 responses in 77 patients are required to confirm the 35% target response rate with 95% confidence. If the full analysis set includes all 85 patients, then at least 24 responses are required for confirmation of the target response rate. Dr. Dan DeAngelo, Assistant Professor at Harvard Medical School and the Dana Farber Cancer Institute and an investigator on the trial commented, "The treatment of elderly patients with poor-risk AML represents a significant unmet medical need in clinical oncology, and it is important that we find new effective treatment options. Agents such as Cloretazine(R) (VNP40101M) have the potential to address this need." Dr. Gary Schiller, Professor of Medicine at the UCLA Geffen School of Medicine and an investigator on the trial added, "This was a very important study for older AML patients treated here at UCLA. As a single agent therapy administered over 30 to 60 minutes, Cloretazine(R) (VNP40101M) is clearly an active agent with the potential to play an important role in the treatment of this difficult population."