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VioQuest Pharmaceuticals Enters Into Clinical Trial Agreement for Novel Akt Inhibitor VQD-002 With the National Cancer Institute

Posted on: Tuesday, 26 February 2008, 09:00 CST

VioQuest Pharmaceuticals (OTCBB: VQPH) announced today that the Company and the U.S. National Cancer Institute (NCI) Center for Cancer Research have entered into a Clinical Trial Agreement (CTA) for the Company's product candidate VQD-002 (triciribine phosphate monohydrate or TCN-P). VQD-002 is a small molecule anticancer compound that inhibits activation of protein kinase B (PKB or AKT), a key component of the phosphoinosotide-3 kinase (PI3K) signaling pathway known to promote cancer cell growth and survival as well as resistance to chemotherapy and radiotherapy.

The agreement provides for the NCI to sponsor a clinical trial of VQD-002 in combination with erlotinib (Tarceva®), an epidermal growth factor receptor (EGFR) inhibitor. EGFR is overexpressed or amplified in a variety of tumor types and is a major target in the treatment of advanced lung cancer and other solid tumors. Recent reports have shown that the sensitivity of multiple types of solid tumors to EGFR inhibitors is dependent on inhibition of the PI3K pathway, suggesting that VQD-002 might be clinically useful to enhance response to erlotinib.

"Through this agreement, we expand the clinical development opportunities for VQD-002 and gain access to the NCI's broad network of scientists conducting NCI-sponsored clinical trials," said Michael D. Becker, president and chief executive officer of VioQuest Pharmaceuticals. "The NCI's efforts will complement our own clinical studies of VQD-002, which will enhance our understanding of the drug's activity and safety as an anti-tumor agent. The knowledge gained from our combined efforts will hopefully lead to VQD-002 becoming an important new drug in the war against cancer."

The NCI has played an active role in the development of drugs for cancer treatment for over 50 years. This is reflected in the fact that approximately one half of the chemotherapeutic drugs currently used by oncologists for cancer treatment were discovered or developed at NCI. The NCI supports about 1,500 clinical trials through a variety of programs, some of which are conducted by NCI researchers at the National Institutes of Health in Bethesda, MD, while others take place at cancer centers, hospitals, and community practices across the country.

"The NCI is very excited to test the combination of triciribine and erlotinib," said Phillip A. Dennis, M.D., Ph.D., of the Medical Oncology Branch of the National Cancer Institute's Center for Cancer Research. "Triciribine is an inhibitor of Akt, an important target in cancer. It is of special interest in lung cancer, where multiple mechanisms of resistance to erlotinib are associated with maintenance of Akt activation. The combination of triciribine and erlotinib could improve the efficacy of erlotinib, and extensive analysis of patient specimens could provide mechanistic insights into how these drugs might work together."

About VQD-002

VQD-002 (triciribine phosphate monohydrate, or TCN-P), a tricyclic nucleoside that inhibits the activation of Akt, has demonstrated anti-tumor activity against a wide spectrum of cancers in preclinical and clinical studies. Amplification, overexpression, or activation of Akt, also named protein kinase B, have been detected in a number of human malignancies, including prostate, breast, ovarian, colorectal, pancreatic, and hematologic cancers. Activation of Akt is associated with cell survival, malignant transformation, tumor invasiveness, and chemo-resistance, while inhibition of Akt activity has been shown to cause cell death. These attributes make Akt an attractive target for cancer therapy.

About Lung Cancer

According to the American Cancer Society, lung cancer (both small cell and non-small cell) is the second most common cancer in both men (after prostate cancer) and women (after breast cancer). It accounts for about 15% of all new cancers. During 2008, there will be about 215,020 new cases of lung cancer (114,690 among men and 100,330 among women).

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: VQD-002 (triciribine phosphate monohydrate), a targeted inhibitor of Akt phosphorylation, which is currently being tested in Phase I clinical trials in both solid and hematological malignancies; Lenocta™ (sodium stibogluconate), an inhibitor of certain protein tyrosine phosphatases such as SHP-1, SHP-2, and PTP1B, which is currently in a Phase IIa trial for solid tumors; and Xyfid™ (1% topical uracil), which is expected to enter Phase II development in 2008 for the treatment and prevention of Hand-Foot Syndrome, a common side effect from certain chemotherapy treatments.

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, potential clinical trial initiations of VioQuest's product candidates, as well as the potential role these product candidates may play in the treatment of cancers. 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 need for additional capital to 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, 2006. VioQuest assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Source: Business Wire

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