In partnership with the U.S. Army, VioQuest Pharmaceuticals, Inc. (OTC: VQPH) has received USFDA orphan drug designation for VQD-001 (sodium stibogluconate), a treatment for the cutaneous form of leishmaniasis.
VQD-001's development and regulatory filing process for a New Drug Application (NDA) for the treatment of cutaneous leishmaniasis is being processed by VioQuest under a Cooperative Research and Development Agreement (CRADA) with the U.S. Army.
Leishmaniasis currently threatens 350 million people in 88 countries around the world. The leishmaniases 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 many developing countries world-wide.
While the disease remains relatively uncommon in the U.S., military personnel returning from leishmaniasis-infested regions overseas have exhibited a dramatic rise in infection rate.
VioQuest is expecting to file a new NDA for VQD-001 this year based on clinical data from clinical studies conducted by the U.S. Army at the Walter Reed Army Medical Center.
VQD-001 is also being developed by VioQuest for other clinical indications such as melanoma, myeloma, lymphoma and renal cancers.
Source: VioQuest Pharmaceuticals, Inc. (a pdf file)
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