VioQuest Pharmaceuticals, Inc. Announces Phase I/IIa Trial and Enrollment Updates for Akt Inhibitor VQD-002Akt Inhibitor VQD-002

27 Apr 2007
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BASKING RIDGE, N.J., April 27 /PRNewswire-FirstCall/ -- VioQuest Pharmaceuticals today announced that it will proceed with Phase II trials later this year with its direct Akt inhibitor VQD-002. Ongoing trials in patients with refractory leukemia and solid tumors are expected to complete phase I enrollment in June 2007. VQD-002 is a novel direct inhibitor of activation of Akt, a serine-threonine kinase that is over expressed and or hyperactivated in resistant and refractory tumors as well as in aggressive hematologic malignancies. Phase I/IIa clinical trials are currently ongoing at the MD Anderson Cancer Center, Houston, TX, and at the H. Lee Moffitt Cancer Center, Tampa, FL. (Logo: ) The objectives of the clinical trials in hematologic malignancies conducted at MD Anderson and H. Lee Moffitt Cancer Center, include the evaluation of VQD-002's safety profile, pharmacokinetic (PK) and pharmacodynamic (PD) parameters, and the effects VQD-002 has on Akt modulation. Eleven patients have been enrolled in the ongoing leukemia trial. In the leukemia trial, reductions in malignant cells (peripheral blast cells) have been seen in several of the patients following initial therapy. Some patients have had improvements observed in parameters of their bone marrow function (increases in platelet and neutraphil counts). The objectives of the clinical trial in solid tumors conducted at H. Lee Moffitt Cancer Center, include the evaluation of VQD-002's safety profile, pharmacokinetic (PK) and pharmacodynamic (PD) parameters, and the effects VQD- 002 has on Akt modulation. Eleven patients with solid tumors have been enrolled in the phase I portion of the ongoing solid tumor trial. Several of these patients, refractory to prior standard therapy and who were screened and selected for study based on the high level of Akt expression in their tumors, have shown stable disease on study. Phase I enrollment in both the solid tumor and leukemia trials is expected to be completed in June 2007, with phase IIa expansion in each trial starting immediately thereafter in patients with a variety of resistant/refractory solid tumors and malignant leukemias. Akt screening before and during patient treatment will continue to be performed on these patients. "As the pathophysiology of hematologic malignancies continues to be dissected, Akt is emerging as an important therapeutic target for both single therapeutic agent modulation and the development of combinatorial molecular targeted therapeutics," said Professor Frank Giles, Director of the Institute for Drug Development, CTRC and Chairman of the Division of Hematology and Medical Oncology at the University of Texas Health Science Center, San Antonio. "VQD-002 is an exciting novel agent in the context of personalized medicine and molecular targeted therapeutics, coupled with activities seen in the ongoing trials so far, we are enthusiastic about investigating rapidly," said Professor Giles, who is Chairman of the VioQuest Scientific Advisory Board. "It is important to note that our Akt activation inhibitor not only blocks the function of all three isoforms of Akt, but also does not result in feedback upregulation of P-Akt levels as observed in other Akt inhibitors. This is a selective, specific, and potent inhibitor of Akt activation. Accordingly, VioQuest would like to exploit this advantage in future combination studies," explained Said M. Sebti, Ph.D., M.D., Director of Drug Discovery Program, Moffitt Cancer Center, Tampa, FL. "While these phase I data should not be overinterpreted, the fact that VQD-002 is being well-tolerated in this advanced patient population is encouraging and supports the substantial and growing pre-clinical data which points to Akt as a key cancer control pathway," said Edward C. Bradley, M.D., VioQuest's Chief Scientific Officer. Discussions of additional Phase II trials of VQD-002 used in combination with other targeted therapies are underway and patient enrollment in these trials could begin by the end of this year. About VQD-002 VQD-002 is a novel direct inhibitor of activation of Akt, a serine- threonine kinase that is overexpressed and or hyperactivated in resistant and refractory tumors as well as in aggressive hematologic malignancies. In a previous phase II study of this compound conducted by the National Cancer InstituteCancer Institute (NCI) in patients with metastatic or recurrent squamous cell carcinoma of the cervix, patients were screened and were treated regardless of their Akt expression levels. In this small, refractory phase II cohort, 1 patient had complete regression for 19+ months, another had partial response for 5+ months, and 8 had stable disease. Subsequent advances in research and technology allowed for a better understanding of the molecular mechanism of action of VQD-002 and have demonstrated it's role in the inhibition of the Akt pathway. Uses of these molecular biomarkers are being employed in these newer trials with the hope that they guide more rational patient selection and thus a higher chance of benefit for any individual patient. About VioQuest Pharmaceuticals VioQuest Pharmaceuticals, Inc. focuses on acquiring, developing, and commercializing targeted late preclinical and early clinical stage therapies with unique mechanisms of action for oncology, viral and autoimmune disorders. VioQuest has two targeted therapeutics in Phase I/IIa clinic trials: VQD-002 which inhibits activation of Akt that is seen at abnormally high levels in breast, ovarian, colorectal, pancreatic, and hematologic tumors; and Lenocta(TM), an inhibitor of specific protein tyrosine phosphatases, which has shown compelling preclinical activity in both renal and melanoma cancers. In addition, VioQuest and the U.S. Army are planning to submit an NDA to the FDA in 2007 for Lenocta(TM) for the treatment of leishmaniasis. VioQuest also has recently in-licensed Xyfid(TM), a topical therapy which has shown early clinical promise in the treatment and prevention of chemo-induced hand-foot syndrome. 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. Such statements include, without limitation, statements regarding the expected timing of the conclusion of enrollment on the ongoing Phase I clinical trials and the initiation of Phase II trials of VQD-002. 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. Among other things, there can be no assurances that VioQuest will meet its stated timelines concerning the initiation and conclusion of clinical trials of VQD-002 or that the data presented in this press release will be supported by future clinical trials. Other risks and uncertainties include the possibility that VioQuest's development efforts relating to its product candidates, including VQD-002, will not be successful, the inability to obtain regulatory approval of VQD-002 or 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. Company Contact: Daniel Greenleaf, President and Chief Executive Officer 908-766-4400 ext. 115 dan.greenleaf@vioquestpharm.com Edward Bradley, Chief Scientific Officer 908-766-4400 ext. 118 ed.bradley@vioquestpharm.com Brian Lenz, Chief Financial Officer 908-766-4400 ext. 117 brian.lenz@vioquestpharm.com Photo: NewsCom: AP Archive: PRN Photo Desk, photodesk@prnewswire.comVioQuest Pharmaceuticals, Inc. CONTACT: Daniel Greenleaf, President and Chief Executive Officer,+1-908-766-4400 ext. 115, dan.greenleaf@vioquestpharm.com, or EdwardBradley, Chief Scientific Officer, +1-908-766-4400 ext. 118,ed.bradley@vioquestpharm.com, or Brian Lenz, Chief Financial Officer,+1-908-766-4400 ext. 117, brian.lenz@vioquestpharm.com, all of VioQuestPharmaceuticals, Inc. Web site:
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