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Vion Pharmaceuticals Enters into Agreement to Conduct a Phase I/II Clinical Trial of Cloretazine(R) in Combination with Induction Therapy in Poor Prognosis AML Patients
Date:9/22/2008

NEW HAVEN, Conn., Sept. 22 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced today that it had entered into an agreement with the Institut Paoli-Calmettes in Marseille, France to conduct a multi-center Phase I/II clinical trial of laromustine (Cloretazine (VNP40101M)) with remission-induction therapy in patients aged 18-60 with previously untreated acute myelogenous leukemia (AML) and a poor prognosis based on their cytogenetic profile.

The Institut Paoli-Calmettes will be leading the study for the French cooperative group GOELAMS (Groupe Ouest Est d'Etude des Leucemies et Autres Maladies du Sang).

Alan Kessman, Chief Executive Officer, commented, "We are pleased to be working with the Paoli-Calmettes Institute and GOELAMS on this clinical study to further evaluate the role that Cloretazine can play in frontline AML therapy. This study will provide important information on the combination of Cloretazine and induction therapy in patients with unfavorable cytogenetics that need new treatment options."

Dr. Norbert Vey, Head of the Leukemia Service of the Institut Paoli-Calmettes and Chief Investigator, said, "AML with unfavorable cytogenetics is a very serious form of leukemia from which few patients can be cured currently. The objective of our study is to improve the complete remission rate in these patients with the addition of Cloretazine to a conventional induction regimen."

The trial will be conducted in two parts. In Phase I, the objective is to determine the dose of Cloretazine in combination with daunorubicin and cytarabine. Phase II will determine the complete remission (CR) rate of the combination in AML patients with an unfavorable prognosis based on their cytogenetic profile. Secondary objectives will be to evaluate the tolerance and toxicities of the combination therapy, as well as progression-free survival and overall survival. Patients will be stratified according to age (less tha
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SOURCE Vion Pharmaceuticals, Inc.
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