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FDA Grants Orphan Drug Designation for Novel Akt Inhibitor VQD-002 in Multiple Myeloma

Posted on: Monday, 4 February 2008, 09:00 CST

VioQuest Pharmaceuticals (OTCBB: VQPH) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company's product candidate VQD-002 (triciribine phosphate monohydrate or TCN-P) for the treatment of multiple myeloma. VQD-002 is a small molecule anticancer compound that inhibits protein kinase B (PKB or AKT), a key component of a signaling pathway known to promote cancer cell growth and survival as well as resistance to chemotherapy and radiotherapy. VioQuest Pharmaceuticals has reported preliminary Phase I results from ongoing studies in both solid tumors and hematological malignancies and the company plans to advance VQD-002 into Phase II development in 2008.

"Activation of the Akt pathway is increasingly being recognized as a critical factor promoting cancer cell survival and proliferation in multiple myeloma and many other cancers," commented Michael D. Becker, president and chief executive officer of VioQuest Pharmaceuticals. "By de-activating this pathway, VQD-002 has the potential to be an effective treatment for many cancers including multiple myeloma. Orphan drug designation significantly strengthens our opportunity to advance this promising product candidate to late stage clinical development and commercialization."

Orphan drug designation entitles VioQuest Pharmaceuticals to seven years of marketing exclusivity for VQD-002 upon regulatory approval, as well as the opportunity to apply for grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses and potential waiver of the FDA's application user fee. Orphan status is granted by the FDA to promote the development of new drug therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States.

Preclinical studies in myeloma cell lines have demonstrated the synergy of VQD-002 alone and in combination with a range of therapeutic agents. These results support the initiation of clinical stage research. VioQuest Pharmaceuticals is exploring a range of clinical research study opportunities in collaboration with Oncotherapeutics, Inc. in California.

"Activation of the Akt pathway is a critical event in malignant transformation and survival, and its importance in multiple myeloma continues to emerge," commented James Berenson, M.D., president of Oncotherapeutics. "Inhibition of Akt has already been shown to cause cell death, reduce angiogenesis and reverse drug resistance in preclinical studies across various cancers. With its unique mechanism of action, coupled with the benign safety profile evidenced from ongoing Phase I studies, we are hopeful that VQD-002 will find a place in our cancer treatment armamentarium."

About VQD-002

VQD-002 (triciribine phosphate monohydrate, or TCN-P), a tricyclic nucleoside that inhibits the phosphorylation 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 Multiple Myeloma

Multiple myeloma is a cancer of the bone marrow in which white blood cells called plasma cells, normally responsible for the production of antibodies (proteins that fight infection and disease), are overproduced. The proliferation of these abnormal plasma cells, known as myeloma cells, causes decreased production of normal red and white blood cells. It also decreases production of disease-fighting antibodies and promotes the growth of tumors that typically spread to multiple sites. The decreased white blood cell production damages the immune system while the myeloma tumors can lead to bone deterioration associated with pain and fractures.

The American Cancer Society estimates there were about 20,000 new cases of multiple myeloma in the United States in 2007. More than 10,000 Americans are expected to die of multiple myeloma each year.

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/IIa 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 I/IIa 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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