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Leukemia

U.S. FDA grants orphan drug designation to acute myelogenous leukemia drug

Published in Medical Letter on the CDC and FDA, November 28th, 2004

Vion Pharmaceuticals, Inc. (VION) announced that it has been granted orphan drug designation from the U.S. Food and Drug Administration for Cloretazine (VNP40101M) for the treatment of acute myelogenous leukemia.

Cloretazine (VNP40101M) is a sulfonylhydrazine alkylating agent that is being evaluated by the company in a phase 2 clinical trial for acute myelogenous leukemia.

The company plans to commence a phase 3 trial of Cloretazine in combination with Ara-C in relapsed acute myelogenous leukemia no later than the first quarter of 2005.

Orphan drug designation may be granted to products that treat rare diseases or conditions that...

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