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www.fdanews.com/articles/90941-vioquest-gets-orphan-designation-leishmaniasis-drug

VIOQUEST GETS ORPHAN DESIGNATION LEISHMANIASIS DRUG

January 22, 2007

VioQuest Pharmaceuticals, in partnership with the U.S. Army, has been granted orphan drug designation from the FDA for the active moiety of VQD-001 (sodium stibogluconate) a treatment for the cutaneous form of leishmaniasis.

VioQuest has executed a cooperative research and development agreement with the Army relating to VQD-001's development and regulatory filing process for the treatment of cutaneous leishmaniasis. VioQuest plans to submit a new drug application for VQD-001 later this year based on data from studies conducted by the Army at the Walter Reed Army Medical Center.

Leishmaniasis are parasitic diseases with a wide range of clinical symptoms. Cutaneous leishmaniasis is the most common form of leishmaniasis, a protozoan infection usually found in developing countries, according to the company.

VioQuest is also developing VQD-001 for other clinical indications such as melanoma, myeloma, lymphoma and renal cancer. Accordingly, there are ongoing investigator-initiated and corporate-sponsored Phase I/IIa trials in these indications.