BASKING RIDGE, N.J., June 12, 2006 (PRIMEZONE) -- VioQuest Pharmaceuticals, Inc. (OTCBB:VQPH), a biopharmaceutical company, plans to submit a New Drug Application (NDA) in 2007 with the U.S. Food and Drug Administration (FDA) for VQD-001 (sodium stibogluconate), a protein tyrosine phosphatase inhibitor, for the treatment of leishmaniasis.
VioQuest recently held a voluntary meeting with the FDA and representatives from the U.S. Army to discuss its planned NDA filing. The company expects that the NDA will be based upon published studies and data compiled by the U.S. Army, which has been administering sodium stibogluconate to treat leishmaniasis in servicemen and women serving in Iraq. The Army has indicated that it intends to allow VioQuest to rely on its data in connection with the NDA. VioQuest also intends to request priority review by the FDA of the planned NDA based upon its belief that there exists a current unmet medical need in the U.S. for the treatment of leishmaniasis.
Subject to approval by the FDA and the U.S. Army, VioQuest is currently exploring its options for marketing and commercializing VQD-001 for the treatment of leishmaniasis in the U.S.
About Leishmaniasis
Leishmaniasis is a parasitic disease with a wide range of clinical symptoms. The cutaneous disease usually presents itself with a chronic non-healing ulcer. Although usually a person only has one to three ulcers, sometimes infection can lead to several ulcers -- sometimes up to 50 -- causing serious disability and permanent scarring. Cutaneous forms of the disease normally produce skin ulcers on the exposed parts of the body such as the face, arms and legs, while the mucocutaneous form of leishmaniasis can lead to partial or total destruction of the mucous membranes of the nose, mouth or throat cavities, as well as surrounding tissues. Visceral leishmaniasis, also known as kala azar, is characterized by irregular bouts of fever, substantial weight loss, swelling of the spleen and liver, and anemia.
According to the World Health Organization, leishmaniasis currently threatens 350 million men, women and children in 88 countries around the world. If left untreated, the fatality rate in developing countries can be as high as 100% within two years. Sodium stibogluconate has been utilized in the treatment of leishmaniasis for more than fifty years in parts of Africa and Asia. It is also currently being used by the U.S. military to treat servicemen and women in Iraq who have contracted cutaneous leishmaniasis.
About VioQuest Pharmaceuticals, Inc.
VioQuest Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing targeted late preclinical and early clinical stage therapies with unique mechanisms of action for oncology, viral and autoimmune disorders. A pioneer in personalized therapeutics, VioQuest has two targeted oncology compounds in clinical trials: VQD-001, an inhibitor of specific protein tyrosine phosphatases, has shown compelling preclinical activity in both renal and melanoma cancers and VQD-002 which has shown to inhibit the phosphorylation of Akt which can be seen in abnormal levels in breast, ovarian, colorectal, pancreatic, and liquid cancers.
VioQuest's subsidiary Chiral Quest, a leader in asymmetric chemocatalysis and custom synthesis, offers its proprietary technology products to well-known pharmaceutical and fine chemical companies worldwide to improve their production efficiencies and, in some instances, to increase the overall safety and efficacy of the underlying drug.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties that could cause VioQuest's actual results and experiences to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that the FDA will approve VioQuest's planned NDA submission relating to VQD-001 for the treatment of leishmaniasis, and even if approved, there is no assurance that VioQuest will be able to successfully commercialize VQD-001 for the treatment of leishmaniasis or any other indication. Other risks and uncertainties include the possibility that the results of clinical trials will not support VioQuest's claims, the possibility that VioQuest's development efforts relating to its product candidates, including VQD-001 and VQD-002, will not be successful, the inability to obtain regulatory approval of VioQuest's product candidates, VioQuest's reliance on third-party parties to develop its product candidates, including the U.S. Army in connection with the planned NDA relating VQD-001 for the treatment of leishmaniasis, its lack of experience in developing and commercializing pharmaceutical products, and the possibility that its licenses to develop and commercialize its product candidates may be terminated. Additional risks are described in VioQuest's Annual Report on Form 10-KSB for the year ended December 31, 2005. VioQuest assumes no obligation and does not intend to update these forward-looking statements, except as required by law.