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news.Vion Pharmaceuticals has signed an agreement with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology to conduct a clinical trial of laromustine with standard remission-induction therapy in patients aged 18-65 with previously untreated acute myelogenous leukemia and high-risk myelodysplasia.
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The trial has been designed as a Phase III study in two parts. Part A will determine the feasibility of laromustine (Cloretazine) 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, the complete remission rate, disease free survival, risk of relapse and overall survival, as well as the tolerance and toxicity, and pharmacokinetics of the combination.
The trial is expected to start 2008 fall and will be conducted at various sites in the Netherlands, Belgium, Switzerland and Norway.
Alan Kessman, CEO of Vion, said: “We are pleased to be working with Cooperative Trial Group for Hematology Oncology (Hovon), one of the prestigious clinical groups in hematology oncology. This trial will provide important data with regard to Cloretazine’s utility in the treatment of acute myelogenous leukemia when given in combination with standard remission-induction therapy for this devastating disease.”