Vion Pharmaceuticals receives orphan drug designation for cancer treatment

By Lisa Kerner

Erie, Pa., Jan. 23 - Vion Pharmaceuticals, Inc. said that orphan designation was granted by the European Commission to its lead anticancer agent, Cloretazine, for the treatment of acute myeloid leukemia.

The designation was granted to Vion (UK) Ltd., the company's wholly owned European subsidiary, under the product name of 1,2-bis (methylsulphonyl)-1-(2-chloroethyl)-2-[(methylamino)carbonyl] hydrazine, according to a company news release.

Acute myeloid leukemia affects about 32,000 persons in the European Union, according to the release.

Orphan drug status is granted by the European Commission to promote development of drugs to treat rare diseases or conditions. The designation entitles Cloretazine to 10 years of market exclusivity in the indication of acute myeloid leukemia, reduced fees associated with applying for market approval, and access to E.U. research funding, according to the company.

Demonstration of quality, safety and efficacy is needed before Cloretazine can be granted a marketing authorization.

Cloretazine, a unique sulfonylhydrazine alkylating agent, is being evaluated in a phase 3 trial in combination with cytarabine in relapsed acute myelogenous leukemia, according to the release. Trials of Cloretazine as a single agent in previously untreated elderly acute myelogenous leukemia and other cancers are also underway.

Vion Pharmaceuticals, based in New Haven, Conn., develops cancer therapeutics.

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