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news.Vion Pharmaceuticals, which develops and commercializes cancer therapeutics, has signed an agreement with the Institut Paoli-Calmettes in Marseille, France to conduct a multi-center Phase I/II clinical trial of laromustine with remission-induction therapy in patients aged 18-60 with previously untreated acute myelogenous leukemia and a poor prognosis based on their cytogenetic profile.
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The trial will be conducted in two parts. In Phase I, the objective will be to determine the dose of Cloretazine in combination with daunorubicin and cytarabine. Phase II will determine the complete remission rate of the combination in acute myelogenous leukemia (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. The prognostic value of various molecular markers will also be studied. The trial is expected to start at fall of 2008 and will be conducted at various sites in France.
Alan Kessman, CEO of Vion, said: “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.”