BASKING RIDGE, N.J., Nov. 26 /PRNewswire-FirstCall/ -- VioQuest Pharmaceuticals today announced the initiation of a Phase IIa study of Lenocta(TM) (sodium stibogluconate), a novel protein tyrosine phosphatase inhibitor, in combination with interferon alpha, an immune stimulant approved for the treatment of hepatitis C, hepatitis B and a number of cancers. The open-label Phase IIa study is designed to enroll at least 12 more patients.
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The Phase IIa trial will evaluate the clinical efficacy and biological effectiveness of Lenocta at the highest tolerable dose in combination with interferon alpha in patients with advanced-stage solid tumors.
“We have reached a significant milestone in the development of Lenocta as a potential cancer therapy with the initiation of this trial,” said Michael D. Becker, President and Chief Executive Officer of VioQuest Pharmaceuticals. “We will continue to advance our portfolio of novel compounds for various cancer indications into clinical development, the goal of this drug development organization.”
Razelle Kurzrock M.D., Professor of Medicine Chair, Department of Investigational Cancer Therapeutics at The University of Texas M.D. Anderson Cancer Center is the lead principal investigator for the study, while Aung Naing M.D. of the same institution and Claire Verschraegen M.D. of The University of New Mexico Cancer Center are participating co-principal investigators.
Data from the recently concluded Phase I trial for Lenocta demonstrated pharmacodynamic activity in some solid tumors as demonstrated by increases in the activities of natural killer cells, CD8 and type II dendritic cells.
About Lenocta
Lenocta, a pentavalent antimonial originally used for the treatment of the parasitic disease leishmaniasis, is an inhibitor of multiple protein tyrosine phosphatases (PTPases), specifically the src homology PTPase (SHP-1 & SHP-2) and PTP1B. Lenocta has also been demonstrated to augment cytokine signaling and responses in hemopoietic cell lines, which can enhance the body’s immune system. Preclinical testing of Lenocta has demonstrated anti-tumor activity against a wide spectrum of cancers.
About PTPases
The protein tyrosine phosphatase superfamily of enzymes functions in a coordinated manner with protein tyrosine kinases to control signaling pathways that underlie a broad spectrum of fundamental physiological processes and represent a new class of therapeutic targets. The PTPases SHP-1 and SHP-2 modulate progenitor cell development, cellular growth, tissue inflammation, cellular chemotaxis, and directly control cell survival involving oxidative stress pathways. SHP-1 and SHP-2 are fundamental for the function of several growth factor and metabolic pathways with far reaching implications for disease pathways and disorders such as diabetes, neurodegeneration, and cancer.
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 Akt, a member of the serine/threonine-specific protein kinase family that is amplified, overexpressed, and/or activated in prostate, breast, ovarian, colorectal, pancreatic, and hematologic cancers; Lenocta(TM), an inhibitor of specific protein tyrosine phosphatases SHP-1, SHP-2, and PTP1B that has demonstrated clinical and biological activity in solid tumors; and Xyfid(TM), a topical therapy which is being developed for the treatment and prevention of chemotherapy-induced Hand-Foot Syndrome (HFS). VioQuest anticipates commencing Phase II trials for VQD-002, and Xyfid in the first half of 2008. 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 2008 for Lenocta for the treatment of leishmaniasis.
Further information about VioQuest can be found at 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, 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.
Michael.becker@vioquestpharm.comBrian.lenz@vioquestpharm.comLisa.lindberg@vioquestpharm.com
CONTACT: Michael Becker, President and Chief Executive Officer, ext. 115,
Michael.becker@vioquestpharm.com, Brian Lenz, Chief Financial Officer, ext.
117, Brian.lenz@vioquestpharm.com, or Lisa Lindberg, VP, Investor Relations
and Corporate Communications, ext. 116, Lisa.lindberg@vioquestpharm.com,
all of VioQuest Pharmaceuticals, +1-908-766- 4400
Web site: http://www.vioquestpharm.com//
