aber cofactor ist das aussichtsreichste produkt der firma
cofactor ist aktuell phase 3!!!
Houston, Texas, November 6, 2000 Biokeys Pharmaceuticals, Inc. (BKYS Pink Sheets) announced today the initiation of a study that will mark a significant move forward in the use of pharmacogenomics applied to the field of predictive cancer chemotherapy for its key cancer drug, CoFactor, a biomodulator for chemotherapy for colorectal and breast cancer patients. Pharmacogenomics is an emerging technology intended to enable clinicians to genetically prescreen patients to predict their response to cancer chemotherapy. Use of this technology will benefit the practice of medicine, as far as cost containment, and create a new system of patient enrollment, which could result in much higher success rates for those patients who are selected for therapy.
Biokeys' lead compound, CoFactor (5,10 methylene-tetrahydrofolate), is a biomodulating agent designed to improve the performance and reduce the side effects associated with 5FU (5-Fluorouracil). 5-FU is currently the world's most widely used chemotherapeutic agent. A Phase II study on CoFactor was recently completed at the Sahlgrenska University Hospital/Östra in Göteborg, Sweden, by Biokeys' scientists. Sixty-two cancer patients were studied, with responses showing average duration of remissions of 9-15 months. This response represents a two-fold increase over 5-FU/leucovorin, which is the current therapy. Toxicity was milder than expected for 5-FU or 5-FU/leucovorin, and no toxicities, per se, of CoFactor were observed. Based on these promising results, Biokeys will undertake the retrospective study to analyze patient tissues from these trials in order to prepare for and facilitate rapid progress for Phase III human trials in Scandinavia and the United States.
Since the Phase II clinical trial was conducted, technology for analyzing enzyme levels has progressed. The Company believes that genomic screening will be very useful for determining the most likely candidates for successful 5-FU/CoFactor therapy. Therefor, Biokeys is undertaking a study on tissue samples from the 62 patients who were previously treated in Phase I/II trials. Analyses will be based upon a RT-PCR (Reverse Transcriptase - Polymerase Chain Reaction) from paraffin-embedded tissues. This improved technology, which permits retrospective analyses from paraffin-fixed tissues, will enable Biokeys' scientists to better understand previous responses by the patients treated in the Phase I/II trials. Work will be conducted by Biokeys' scientists in Sweden and the United States, over the next five months, during which time the Company will prepare for Phase III human trials.
The new Biokeys Pharmaceuticals 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. Also in development is EradicaideÔ, a cell mediated, antibody-negative immunotherapeutic/vaccine, which has shown the ability in recently completed primate trials to reduce HIV viral loads to undetectable levels with no development thus far of viral resistance. The Company is now preparing a Form 10-SB filing with the United States Securities and Exchange Commission to make Biokeys a "fully-reporting company", followed by application for a listing on the American Stock Exchange.
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, 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.
