VIOQUEST GETS ORPHAN DESIGNATION LEISHMANIASIS DRUG
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.