NEW HAVEN, Conn., Aug. 19 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Pink Sheets: VION) announced today that it had entered into an agreement with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (the "HOVON") to conduct a clinical trial of laromustine (Cloretazine(R) (VNP40101M)) with standard remission-induction therapy in patients aged 18-65 with previously untreated acute myelogenous leukemia (AML) and high-risk myelodysplasia (MDS).
Alan Kessman, Chief Executive Officer, commented, "We are pleased to be working with HOVON, one of the most prestigious clinical groups in hematology oncology. We continue to believe that Cloretazine(R) will have broad utility in the treatment of hematological malignancies as both a single agent and in combination with other therapies. This trial will provide important data with regard to Cloretazine(R)'s utility in the treatment of AML when given in combination with standard remission-induction therapy for this devastating disease."
Dr. Bob Lowenberg, Chief Investigator of HOVON, said, "HOVON is focusing on the clinical development of new therapeutic options for patients with leukemia. Laromustine is a promising agent for that effort."
The trial has been designed as a Phase III study in two parts. Part A will determine the feasibility (based on safety and preliminary effectiveness) of laromustine administration at three possible dose levels in combination with cytarabine and idarubicin. Part A will also evaluate the pharmacokinetics and the clinical efficacy of the laromustine combination.
Part B is then designed to evaluate the clinical efficacy of the
laromustine combination versus two cycles of cytarabine and idarubicin
without laromustine with regard to clinical outcome ("event free
survival"), the complete remission rate, disease free survival (DFS), risk
of relapse and overall survival (OS), as well as the tolerance and
toxicity, and pharmacokinetics of the combin
|SOURCE Vion Pharmaceuticals, Inc.|
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