VioQuest Pharmaceuticals Submits 510(k) Application To FDA For Xyfid™, A Novel Topical Agent For The Treatment Of Various Skin Disorders

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 03 Jul 2008 - 5:00 PDT

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VioQuest Pharmaceuticals (OTCBB: VOQP) announced the submission of a 510(k) application to the United States Food and Drug Administration (FDA). The application seeks marketing clearance for Xyfid™ (1% uracil topical), a topical skin preparation intended to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other dry skin conditions, by maintaining a moist wound and skin environment. If cleared by the FDA, Xyfid™ will be the company's first commercial product.

"The submission of our 510(k) application for Xyfid™ marks an important milestone in our company's history and we look forward to reporting our progress on this and on other fronts in the months ahead," said Michael D. Becker, president and CEO of VioQuest Pharmaceuticals. "With this submission, we are also well positioned to consider opportunities for partnership or collaboration to support the commercialization strategy for this novel supportive care oncology product candidate."

About VioQuest Pharmaceuticals

VioQuest Pharmaceuticals is a New Jersey-based biotechnology company dedicated to becoming a recognized leader in the successful development of novel drug therapies targeting both the molecular basis of cancer and side effects of treatment. VioQuest's oncology portfolio includes: Xyfid™ (1% uracil topical), for the treatment of dry skin conditions and to manage the burning and itching associated with various dermatoses; VQD-002 (triciribine phosphate monohydrate), a targeted inhibitor of Akt activation; and Lenocta™ (sodium stibogluconate), an inhibitor of certain protein tyrosine phosphatases such as SHP-1, SHP-2, and PTP1B.

Further information about VioQuest can be found at http://www.vioquestpharm.com.

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 forward-looking statements concern the timing, progress and results of the clinical development, regulatory processes, potential clinical trial initiations of VioQuest's product candidates, as well as our ability to complete strategic transactions. 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. These statements are subject to various risks and uncertainties and include VioQuest's immediate need for additional capital to cover its current obligations and future operating expenses and fund its clinical development programs, 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 will not be successful, the inability to obtain regulatory approval of VioQuest's product candidates, VioQuest's reliance on third-party researchers to develop its product candidates, 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, 2007. VioQuest assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

VioQuest Pharmaceuticals