BASKING RIDGE, N.J., May 3, 2006 (PRIMEZONE) -- VioQuest Pharmaceutical's (OTCBB:VQPH) Investigational New Drug (IND) application was accepted for VQD-002, triciribine-phosphate (TCN-P) by the U.S. Food and Drug Administration (FDA).
VQD-002 is a tricyclic nucleoside that targets intracellular AKT, by inhibiting its phosphorylation and, therefore, its ability to activate important cancer pathways. Although initially tested in small pilot studies at the NCI, its full therapeutic potential was not recognized until preclinical work recently demonstrated that it is a more potent inhibitor of AKT phosphorylation than other compounds in a National Cancer Institute diversity set, and that individual cancers in patients could be scored for their degree of activated AKT. AKT over-expression has been observed in many cancer types, including breast, ovarian, colorectal, pancreatic, and leukemia. AKT is considered to be a very attractive therapeutic target by clinicians, scientists and industry. The Company believes VQD-002 is the first direct inhibitor of AKT currently under clinical development.
In a prior university-sponsored Phase II trial, VQD-002 showed activity in various tumor types. Using immunohistochemical assays that have been developed since that trial, patients, whose tumors over-express AKT, can be pre-selected for treatment with VQD-002, analogous to the way patients whose tumors over-express HER2 are pre-selected for treatment with Herceptin(R). The Company believes that by pre-selecting a target population whose tumors have abnormally high levels of phosphorylated AKT, the drug can be dosed at relatively low-levels, which will be able to enhance the response rate in clinical trials of VQD-002, while allowing the Company to conduct its clinical trials more cost effectively.
"We are excited about the progress we've made in advancing our personalized therapeutic, VQD-002, through its preclinical development," said Daniel Greenleaf, president and chief executive officer of VioQuest. "We believe VQD-002, with its unique mechanism of action, could become a potent new therapy for patients suffering from various types of cancer where AKT hyper-activation is apparent. This IND filing is an important step in that direction."
VioQuest plans to initiate Phase I/IIa trials in both solid and liquid tumors in the second quarter of 2006.
About VioQuest Pharmaceuticals, Inc.
VioQuest Pharmaceuticals, Inc. acquires, develops and commercializes targeted late preclinical and early clinical stage therapies with unique mechanisms of action for oncology, viral and autoimmune disorders. A leader in personalized therapeutics, VioQuest has two targeted therapeutics in clinical trials: VQD-001, an inhibitor of specific protein tyrosine phosphatases, as well as an immune potentiator, has shown compelling preclinical activity in both renal and melanoma cancers, and VQD-002, which has been shown to inhibit the phosphorylation of AKT which is common in many ovarian, colorectal, breast, pancreatic cancers and in leukemia.
VioQuest's subsidiary Chiral Quest, a pioneer in asymmetric chemocatalysis and custom synthesis, offers its proprietary technology products and services 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. For more information please visit www.vioquestpharm.com.
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 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 any of VioQuest's research programs and compounds will be successfully commercialized. Other risks and uncertainties that affect forward-looking statements contained in this press release include the possibility that the market for the sale of certain products may not develop as expected; that development of our product candidates may not proceed as planned, the possibility of being unable to obtain regulatory approval of VioQuest's product candidates, the risk that the results of clinical trials may not support VioQuest's claims, and risks related to VioQuest's ability to protect its intellectual property and its reliance on third parties to develop its product candidates. 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.