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news.Vion Pharmaceuticals is planning to conduct a pivotal phase II trial of its anticancer agent Cloretazine in elderly patients with poor-risk acute myelogenous leukemia.
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Elderly poor-risk acute myelogenous leukemia (AML) is the disorder in patients over sixty years of age that have certain risk factors affecting the outcome of treatment.
The company plans to initiate the pivotal phase II trial, CLI-043, as soon as practicable in at least 20 sites in North America and Europe. At this time, the trial is planned to accrue approximately 85 patients.
“Treatment for this population of patients represents an unmet medical need. Together with our previous phase II study in an elderly AML population, results from this trial, if successful, will form the clinical basis for a submission to the FDA of a new drug application for Cloretazine,” said Ann Cahill, vice president, Clinical Development.
In October 2005, Vion received a fast track designation from the FDA for Cloretazine in the treatment of elderly patients with poor-risk AML.