Vion to test Cloretazine in elderly leukemia patients

By Elaine Rigoli

Tampa, Fla., May 24 - Vion Pharmaceuticals, Inc. has started a phase 2 trial of Cloretazine (VNP40101M) as a single agent in previously untreated elderly patients with de novo poor-risk acute myelogenous leukemia.

The company said the trial is expected to be conducted in more than 20 North American and European sites. Accrual of 85 patients is expected to take about one year.

"We are very pleased to have this pivotal trial of Cloretazine underway. The treatment of elderly patients with poor-risk acute myelogenous leukemia is an unmet medical need in clinical oncology. Based on our previous phase 2 trial, in which Cloretazine achieved a complete remission rate of 50% in elderly patients with de novo acute myelogenous leukemia, we believe that Cloretazine can play an important role in the treatment of older patients with acute leukemia," said Ann Cahill, vice president of clinical development, in a news release.

Cloretazine is a novel alkylating agent that is also being evaluated in a pivotal phase 3 trial in combination with cytarabine (Ara-C) for the treatment of patients of any age with relapsed acute myelogenous leukemia.

This 420 patient phase 3 trial is being conducted in 65 North American and European sites and is expected to reach its interim evaluation point (210 patients evaluated for response) in the second half of 2006, the release said.

Vion, located in New Haven, Conn., develops cancer therapeutics.

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