Biokeys Pharmaceuticals Inc. Announces CoFactor Clinical Trial Plan.

Business Editors & Health/Medical Writers

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SAN DIEGO--(BW HealthWire)--June 19, 2002

Biokeys Pharmaceuticals Inc. (OTCBB:BKYS) announced today that the Company has completed its clinical trial design for testing its biomodulator, CoFactor(TM), for use with 5-FU (5-Fluorouracil) in the United States during the second half of 2002.

According to Biokeys Pharmaceuticals' Medical Director, Dr. Chris Chapman, M.D., "The clinical trial plan is based upon our open label first-line Phase II IND approval by the US FDA. We look forward to beginning treatment of metastatic colorectal cancer patients in this Phase II trial with CoFactor and 5-FU." To the best of the Company's knowledge, this IND is one of few Phase II trials approved for first-line therapy in the U.S. for metastatic colorectal cancer in the past several years.

CoFactor will be administered at a 100 mg. IV dose in conjunction with IV 5-FU. This dose level was associated in a previous Phase II trial conducted in Sweden with a median time to tumor progression (TTP) of 16.5 months in CoFactor treated patients. In currently available therapies, median TTP is less than 8 months.

CoFactor (5, 10- methylenetetrahydrofolate) is a patented drug that has been shown to enhance the performance of 5-FU so that it inhibits TS (thymidylate synthase), a key enzyme necessary for cancer cell growth. Biokeys Pharmaceuticals is the exclusive licensee of this compound, which has already been tested in the above mentioned Swedish Phase II human trial in patients with gastrointestinal and breast cancers. This testing involved patients who were both naive to chemotherapy and patients who had progressed on chemotherapy with 5-FU and leucovorin, with statistically significant results in both patient populations.

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. In addition to CoFactor, BlockAide/CRTM is in development as a viral entry inhibitor for HIV and has demonstrated the ability to significantly lower viral load in primate studies and is being readied for human trials. Also in development is EradicAide(TM), a cell mediated, antibody-negative therapeutic vaccine for HIV Infection/AIDS. In primate trials, EradicAide has demonstrated the ability to reduce HIV viral loads to undetectable levels, reduce HIV transmissibility and delay progression to AIDS.

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.