BASKING RIDGE, N.J., Sept. 26 /PRNewswire-FirstCall/ -- VioQuest Pharmaceuticals, Inc. , announced today that it has dosed the first patient in its Phase I/IIa clinical trial of VQD-001, Sodium Stibogluconate (SSG), for evaluation of solid tumors, at the MD Anderson Cancer Center. VQD-001 has shown in preclinical studies to specifically inhibit protein tyrosine phosphatases (PTPs), a family of enzymes believed to play a crucial role in solid tumor formation. PTPs are over-expressed in many advanced malignancies, including renal cancer and melanoma. Based on preclinical activity demonstrated in animal models, VQD-001 may represent a novel oncology therapeutic for halting solid tumor growth.
The MD Anderson trial is under the direction of principal investigator Luis Camacho, M.D., M.P.H., and is the first corporate-sponsored study of VQD- 001. Dr. Camacho is an Assistant Professor in the Phase I Program, Division of Cancer Medicine, whose research interests include cell signal inhibition and specific antibody mediated therapies.
The trial is a Phase I/IIa, open-label, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of VQD-001 in combination with Interferon alpha-2b for patients with advanced malignancies.
Among the goals of this clinical trial is to find the highest tolerable dose of VQD-001 combined with Interferon alfa-2b in the treatment of patients with advanced cancer that have not responded to standard treatment or where there is no standard treatment for that type of cancer. The effectiveness and safety of this drug combination will also be studied.
Researchers also want to study the pharmacokinetics (PKs) of the treatment. PK testing is the study of what the body does to a drug over time, including how it is absorbed into the body, how it moves throughout the body, and how the body gets rid of the drug.
Dr. Camacho said, “I am most pleased to be leading this trial. VQD-001’s long safety history gives us a real boost as we explore its anti-tumor activity in patients with advanced solid tumors. The pre-clinical animal models are very encouraging and our trial could shed light to a new family of anti-cancer compounds.”
Dan Greenleaf, president and CEO of VioQuest, added, “The acceptance of our IND and the commencement of the trial for VQD-001 mark the achievement of another important clinical milestone for VioQuest. We are very excited about the potential of this compound and we look forward to further clinical progress in the months ahead.”
There is an investigator-initiated Phase I/IIa study of VQD-001 in advanced malignancies currently in progress at the Cleveland Clinic Taussig Cancer Center, led by Ernest C. Borden, M.D., Director of Experimental Drug Discovery and Development, and Ronald Bukowski, M.D., Head of Experimental Therapeutics and Deputy Director of the Center. This trial is fully funded by the National Institutes of Health. VioQuest expects to report interim results from this trial during the first half of 2007.
About VQD-001: Sodium Stibogluconate (SSG)
VQD-001 is a clinical stage drug with a novel anti-tumor action that has potential as a treatment for cancer, either alone or in combination with other therapeutics. It has shown compelling preclinical activity, in multiple myeloma, malignant melanoma, bladder, and colon cancer cell lines. Investigators at the Cleveland Clinic Taussig Cancer Center found that VQD-001 inhibits specific protein tyrosine phosphatases (PTPases), which are over-expressed in certain cancers. This over-expression plays an integral role in tumor growth in certain cancers.
About VioQuest Pharmaceuticals, Inc.
VioQuest Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing targeted late preclinical and early clinical stage therapies with unique mechanisms of action for oncology, viral and autoimmune disorders. A pioneer in targeted therapeutics, VioQuest has two oncology compounds in clinical trials. VQD-001, an inhibitor of specific protein tyrosine phosphatases, has shown compelling preclinical activity in both renal and melanoma cancers; and VQD-002, which inhibits the phosphorylation of Akt, an enzyme found in abnormal levels in breast, ovarian, colorectal, pancreatic, and liquid cancers.
VioQuest’s subsidiary, Chiral Quest, a leader in asymmetric chemocatalysis and custom synthesis, offers its proprietary technology products to well-known pharmaceutical and fine chemical companies worldwide to improve their production efficiencies and, in some instances, to increase the overall safety and efficacy of the underlying drug.
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. 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’s clinical trials relating to VQD-001 will be successful or that VioQuest will be able to successfully commercialize VQD- 001 for the treatment of solid tumor cancers or any other indication. Other risks and uncertainties 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 VQD-001 and VQD -002, 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, 2005. VioQuest assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Contact: VioQuest Pharmaceuticals, Inc.: Daniel Greenleaf Brian Lenz Chief Executive Officer Chief Financial Officer 908-766-4400 908-766-4400 Noonan Russo: Sharon Weinstein Benjamin Carmichael Investor Relations Media 212-845-4271 212-845-4242
VioQuest Pharmaceuticals, Inc.
CONTACT: Daniel Greenleaf, Chief Executive Officer, or Brian Lenz, ChiefFinancial Officer, both of VioQuest Pharmaceuticals, Inc., +1-908-766-4400;Sharon Weinstein, Investor Relations, +1-212-845-4271, or BenjaminCarmichael, Media, +1-212-845-4242, both of Noonan Russo
