|
 |
|||||||
 |
PRESS RELEASES Biokeys Pharmaceuticals, Inc. announces that it has initiated manufacturing of its Colorectal Cancer drug for Phase II human trials Company Seeks to Replicate Success of Swedish Trials San Diego – June 5, 2003 – Biokeys Pharmaceuticals, Inc. (OTCBB:BKYS - News), a biopharmaceutical company specializing in Cancer and HIV/AIDS therapeutics, today announced that it has begun manufacturing of the drug CoFactor™ under fully compliant cGMP guidelines to enable initiation of human clinical trials in the United States. CoFactor is formulated to improve the performance of 5-FU-based therapies to treat metastatic colorectal cancer. It will be tested in newly diagnosed metastatic colorectal cancer patients in a first-line Phase II human trial beginning in the second half of this year and into 2004. Dr. Joan Robbins, the Company's Chief Technical Officer, stated that "In previously conducted Phase II human trials in Sweden, a 100mg dose of CoFactor, given 20 minutes before IV administration of 5-FU, was able to extend the median time to tumor progression in metastatic colorectal cancer patients to 14.7 months and median survival to 21.5 months. This translates to approximately a seven month increase in both median time to tumor progression and survival over the approved first-line therapy for metastatic colorectal cancer in the United States. We believe that CoFactor could serve to improve the overall clinical benefit of 5-FU-based combination chemotherapies including Camptosar® (Pfizer - NYSE: PFE) and Eloxatin™ (Sanofi-Synthelabo - Euronext: "SAS" / NYSE: SNY), as well as promising new compounds under development such as Erbitux® (Imclone Systems, Inc. - NASDAQ:IMCL) and Avastin™ (Genentech - NYSE:DNA)." During previous clinical trials, the overall toxicity of the 5-FU/CoFactor regimen was lower than 5-FU alone or 5-FU used in conjunction with leucovorin. CoFactor is a highly stabilized formulation of 5-10 methylenetetrahydrofolate, which is a form of folate that is necessary for the active metabolite of 5-FU to inhibit a key enzyme responsible for cancer cell growth. CoFactor bypasses the metabolic pathway that leucovorin must go through in order to reach this active form. Direct administration of CoFactor has been shown to elevate folate levels in tumors and therefore enable more effective uptake of 5-FU. This may lead to improved overall performance of newly developed drugs that must be added to 5-FU for treatment of metastatic colorectal cancer. About Biokeys Pharmaceuticals Biokeys Pharmaceuticals Inc. is a biopharmaceutical research and development company whose business strategy is to commercialize leading edge medical research through licensing agreements with prominent universities and research institutions. The Company focuses its energy in cancer and antiviral research to launch products that either extend the usefulness of current therapies or replace marginal therapies with new approaches to treatment. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements are made based on management's current expectations and beliefs. Actual results may vary from those currently anticipated based upon a number of factors, including uncertainties inherent in the drug development process, the timing and success of clinical trials, the validity of research results, and the receipt of necessary approvals from the United States Food and Drug Administration. The Company undertakes no obligation to release publicly any revisions, which may be made to reflect events or circumstances after the date hereof. |
