Company Intends to Commence Follow-on Phase IIa Trial
Increase in Dendritic, Natural Killer, and T-cell Activity Observed
BASKING RIDGE, N.J., Oct. 10 /PRNewswire-FirstCall/ -- VioQuest Pharmaceuticals (OTC Bulletin Board: VQPH), a New Jersey-based biopharmaceutical company focused on acquiring, developing and commercializing targeted cancer therapeutics, announced today that it has completed enrollment in its Phase I open-label dose escalation trial of its investigational drug, Lenocta(TM), (sodium stibogluconate) for the treatment of solid tumors. Lenocta(TM) is a potent and selective inhibitor of SHP-1 and SHP-2. Inhibition of these key regulatory enzymes results in the up-regulation of the response to immunologic stimuli (cytokines) and inhibition of mitogenesis. In addition to reaching the maximum tolerated dose (MTD), dose dependent activities were observed in protocol-specified surrogate biomarkers in both cellular and humoral immunologic functions. VioQuest intends to begin enrolling patients in a follow-on Phase IIa.
A total of 17 patients were enrolled in the Phase I study. Asymptomatic hypokalemia was the only dose limiting toxicity (DLT) observed. Analysis of the data showed an increase in pharmacodynamic activities as demonstrated by increase in the activities of natural killer, CD8 and type II dendritic cells.
Edward C. Bradley, M.D., VioQuest's Chief Scientific Officer, stated, "The increased function in T, NK, and dendritic cell populations at a dose that is well tolerated is exactly what we had hoped to see in this Phase I trial, and we look forward to the Phase IIa program which is now ready to enroll patients."
Lenocta(TM) is an inhibitor of multiple protein tyrosine phosphatases (PTPases), specifically the SRC homology PTPase (SHP-1 & SHP-2) and PTB-1B, based on data from several preclinical studies conducted at the Cleveland Clinic. These intracellular enzymes are involved in signaling pathways of many receptor-linked tyrosine kinases which are involved in growth, proliferation and differentiation of cancer cells. Inhibition of these enzymes with Lenocta(TM) can trigger apoptosis, (programmed cell death) of malignant cells. This antiproliferative and pro-apoptotic effects, coupled with its potential ability to enhance the body's immune system, through improved cytokine signaling, T-cell and dendritic cell functions indicate that Lenocta(TM) has potentials as an anti-cancer agent. It is known that one major mechanism of regulating the growth and proliferation of cancer cells involves activation of cellular pathways, especially protein tyrosine kinase pathways and in particular, the Jak/Stat pathway. It has also been recognized that interferon and other cytokines exert their anti-cancer effects via these pathways.
About VioQuest Pharmaceuticals
VioQuest focuses on acquiring, developing, and commercializing targeted late preclinical and early clinical stage therapies with unique mechanisms of action primarily for oncology and infectious diseases. VioQuest has three targeted drug candidates in clinical development: VQD-002 which inhibits activation of Akt that is seen at abnormally high levels in breast, ovarian, colorectal, pancreatic, and hematologic cancers; Lenocta(TM), an inhibitor of specific protein tyrosine phosphatases (PTPases), SHP-1 and SHP-2, which has shown compelling clinical and biological activity in solid tumors and Xyfid(TM), a topical therapy which has shown early clinical promise in the treatment and prevention of chemo-induced Hand-Foot Syndrome (HFS). VioQuest anticipates commencing several Phase II trials for VQD-002, Lenocta(TM) and Xyfid(TM) in the second half of 2007. In addition, VioQuest and the U.S. Army are planning to submit a New Drug Application (NDA) to the U. S. Food and Drug Administration (FDA) in 2007 for Lenocta(TM) for the treatment of leishmaniasis.
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, and potential clinical trial initiations of Lenocta. 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 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), 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.
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|SOURCE VioQuest Pharmaceuticals|
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