Biokeys Pharmaceuticals, Inc. starts manufacturing colorectal cancer agent for Phase II human trials
San Diego, CA, based biopharma company Biokeys Pharmaceuticals, Inc., which specializes in cancer and HIV/AIDS therapies, has begun manufacturing its new CoFactor™ under fully compliant cGMP guidelines to enable clinical trials to go ahead in the US
CoFactor is formulated to improve the performance of 5-FU-based therapies in metastatic colorectal cancer. It will be tested in patients with newly diagnosed, metastatic colorectal cancer in a first-line, Phase II, clinical trial due to begin in the second half of this year and into 2004.
Phase II trials in Sweden, found that a 100mg dose of CoFactor, given 20 min before IV administration of 5-FU, extended the median time to tumor progression in metastatic colorectal cancer patients.
Dr. Joan Robbins, the Company’s Chief Technical Officer, explained the results "translate to about 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 US."
Robbins believes that CoFactor could serve to improve the overall clinical benefit of various 5-FU-based combination chemotherapies, including Camptosar® (Pfizer) and Eloxatin™ (Sanofi-Synthelabo), as well as promising new compounds under development such as Erbitux® (Imclone Systems, Inc.) and Avastin™ (Genentech)."
CoFactor is a highly stabilized formulation of 5-10 methylenetetrahydrofolate. This form of folate is necessary for the active metabolite of 5-FU to inhibit a key enzyme responsible for cancer cell growth. 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 by-passes the metabolic pathway that leucovorin must go through in order to reach the active form. Direct administration of CoFactor has been shown to increase the levels of folate in tumors and consequently 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.
Keywords : Biokeys Pharmaceuticals Inc. Development manufacturing CoFactor™ Leucovorin Active folate cGMP Advanced colorectal cancer 5-FU Phase II trials
