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Vion Pharmaceuticals Receives Orphan Drug Designation for Cloretazine (VNP40101M) in Europe for Treatment of Acute Myeloid Leukemia
NEW HAVEN, CN -- January 23, 2006 -- Vion Pharmaceuticals, Inc. announced today that orphan designation was granted by the European Commission to its lead anticancer agent, Cloretazine® (VNP40101M), for the treatment of acute myeloid leukemia.
The designation was granted to Vion (UK) Limited, the Company's wholly-owned European subsidiary and will appear on the European Medicines Agency website (www.emea.eu.int <http://www.emea.eu.int>) under the product name of 1,2-bis (methylsulphonyl)-1-(2-chloroethyl)-2-[(methylamino)carbonyl] hydrazine.
Receipt of the designation followed from a favorable opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency. Opinions on orphan medicinal products designations are based on the following cumulative criteria: (i) the seriousness of the condition, (ii) the existence or not of alternative methods of diagnosis, prevention or treatment and (iii) the rarity of the condition (considered to affect not more than five in ten thousand persons in the European Community) and (iv) the presentation of evidence of medical plausibility.
Acute myeloid leukemia (AML) is considered to affect about 32,000 persons in the European Union. Orphan drug status is granted by the European Commission to promote development of drugs to treat rare diseases or conditions. Orphan drug designation entitles Cloretazine® to: (i) ten years of market exclusivity for in the indication of AML; (ii) protocol assistance from the European Medicines Agency to optimize drug development in preparing a dossier that will meet regulatory requirements; (iii) reduced fees associated with applying for market approval; and (iv) access to European Union research funding.
An orphan designation is not a marketing authorization. As a consequence, demonstration of quality, safety and efficacy will be necessary before Cloretazine® can be granted a marketing authorization.
Vion Pharmaceuticals, Inc. is developing cancer therapeutics. Vion has two agents in clinical trials: Cloretazine®, a unique sulfonylhydrazine alkylating agent, is being evaluated in a phase 3 trial in combination with cytarabine in relapsed acute myelogenous leukemia.
Trials of Cloretazine® as a single agent in previously untreated elderly acute myelogenous leukemia and high-risk myelodysplastic syndrome, adult and pediatric brain tumors, small cell lung cancer and chronic lymphocytic leukemia, and in combination with temozolomide in hematologic malignancies, are also underway. Triapine®, a potent inhibitor of a key step in DNA synthesis, is being evaluated in trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating KS119W, a hypoxia-selective compound from the sulfonylhydrazine class, and heterocyclic hydrazones. The Company also is seeking development partners for TAPET®, its modified Salmonella vector used to deliver anticancer agents directly to tumors.
SOURCE: Vion Pharmaceuticals, Inc.
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