BASKING RIDGE, N.J., March 29 /PRNewswire-FirstCall/ -- VioQuest Pharmaceuticals (BULLETIN BOARD: VQPH) , a New Jersey based biopharmaceutical Company focused on developing and commercializing targeted therapeutics announced today that it has obtained an exclusive license from Asymmetric Therapeutics, LLC, to develop and commercialize Xyfid(TM), an adjunctive therapy for a common and serious side effect of cancer chemotherapy. Additionally, the Company announced that it has identified VQD- 002-Oral, an orally bioavailable pro-drug analog of VQD-002 (triciribine- phosphate), into its pre-clinical development pipeline.
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Xyfid(TM) is a topical therapy which has shown early clinical promise in the treatment and prevention of Hand-Foot Syndrome (HFS), a common, often dose-limiting and potentially life-threatening complication of several drug regimens, commonly used in the treatment of patients with breast, colon, and other cancers. HFS, also known as palmar-plantar erythrodysesthesia syndrome (PPES), is commonly seen in patients receiving capecitabine (Xeloda(TM)) and has been associated with other fluoropyrimidines (5-FU) and anthracyclines. In addition, HFS is being seen in patients receiving some of the newer tyrosine kinase class of therapies sorafenib (Nexavar(TM)). Incidence of HFS can be as high as 50% in patients receiving initial chemotherapy with higher dose regimens of capecitabine. The risk of developing HFS becomes more likely with each subsequent treatment.
Dan Greenleaf, VioQuest's president and CEO, said, "We have identified a product that has potential to treat an unmet need in cancer patients undergoing rigorous chemotherapy. Once clinical testing verifies the proof of concept that Xyfid(TM) prevents HFS, we believe the regulatory pathway is straightforward."
Edward Bradley, M.D., who has recently joined VioQuest as its Chief Scientific Officer, added, "Xyfid(TM) holds out the promise to make several current chemotherapy regimens safer and easier for patients to tolerate, and may allow patients to maintain the original dose and duration of treatment planned. While additional clinical testing (Phase II, Phase III) must be done to prove this, the preliminary patient observations support moving Xyfid(TM) ahead into advanced testing. No drugs are currently approved for the prevention of HFS."
HFS severity ranges from a mild (Grade I) burning or redness of the palms and soles to a serious, edematous, ulcerated breakdown of the skin (Grade III- IV) which can make it too painful for patients to use their hands or to walk. HFS is a recognized dose-limiting toxicity and may commonly result in the reduction of the dose patients can receive or in the necessity to stop the drug. While the action of Xyfid(TM) is not fully understood, an active component, uracil, may alter the response of the skin to these agents, thus preventing the development of this unwanted side-effect. Phase II studies of Xyfid(TM) are being planned for initiation under an active Investigational New Drug Application (IND) later this year, and has been granted accelerated approval status by the US Food and Drug Administration (FDA).
VioQuest's rights to Xyfid(TM) are pursuant to an exclusive license agreement between Fiordland Pharmaceuticals, Inc., as licensee, and Asymmetric Therapeutics, LLC, as licensor. Fiordland Pharmaceuticals which was originally the licensee under the agreement, has assigned all of its rights under the agreement to VioQuest Pharmaceuticals, Inc.
VQD-002-ORAL
VioQuest also announced that is has added a new product candidate of VQD- 002 to its pre-clinical pipeline. VQD-002-Oral may provide an oral form of VQD-002, currently in Phase I/IIa trials in patients with refractory leukemias and solid tumors.
Dr. Bradley commented, "VQD-002-Oral is being designed to provide dosing flexibility and convenience."
VioQuest has previously announced its intent to transition to an oncology product development company. The Company's strategy includes acquiring rights to additional compounds that have been previously studied in humans, which it believes will mitigate its development risk by providing earlier safety and efficacy data.
About VioQuest Pharmaceuticals
VioQuest Pharmaceuticals, Inc. http://www.vioquestpharm.com/ is 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. VioQuest has two targeted therapeutics in Phase I/IIa clinic trials: VQD-002 which inhibits phosphorylation of Akt that is seen at abnormally high levels in many breast, ovarian, colorectal, pancreatic, and hematologic tumors; and Lenocta(TM), an inhibitor of specific protein tyrosine phosphatases, which has shown compelling preclinical activity in both renal and melanoma cancers. VioQuest and the U.S. Army are planning to submit an NDA to the FDA in 2007 for Lenocta(TM) for the treatment of leishmaniasis. VioQuest's subsidiary Chiral Quest, Inc., a pioneer 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. VioQuest is seeking strategic alternatives for Chiral Quest, which may include its sale.
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 Lenocta(TM) for the treatment of leishmaniasis, and even if approved, there is no assurance that VioQuest will be able to successfully commercialize Lenocta(TM) for the treatment of leishmaniasis or any other indication, or that VioQuest will receive any proceeds in connection with a sale or other disposition of its Chiral Quest division. 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 Lenocta(TM) and VQD-002, 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, 2006. VioQuest assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Contact information:
Daniel Greenleaf
President and CEO
908-766-4400 ext. 115
