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Biokeys Pharmaceuticals Inc. Announces World-Wide Exclusive License, Two New Patents and Thiovir Therapeutic Study for HPV Infection.

Business Editors & Health/Medical Writers


SAN DIEGO--(BW HealthWire)--Dec. 19, 2000

Biokeys Pharmaceuticals Inc. (Pink Sheets:BKYS) announced today that it is exercising its right, under the USC (University of Southern California) Option & License Agreement, dated Aug. 17, 2000, for an exclusive world-wide license to technology based upon platform combinatorial chemistry technology, known as ThioChemistry(TM) and the resulting Thiovir(TM) product line of antiviral and anticancer compounds. This license includes four patents in total, including two new patents, which were issued on Nov. 14, 2000.

As a step toward commercialization of this technology, Biokeys has also initiated funding at USC to further test Thiovir, and Thiovir analogues, for treatment of HPV (human papillomavirus). The main objective of a nine month project is to advance preliminary studies conducted by Biokeys with collaborators at the Gittlen Cancer Research Institute and Hershey Medical Center, Penn State University, in which Thiovir showed evidence of anitiviral efficacy as a topical treatment for animal papillomas. In the new research effort, in vitro and in vivo assays for infectivity of HPV will be studied in a rabbit model, infected with the Shope cottontail rabbit papillomavirus (CRPV), and in an immunosupressed mouse model with human xenographs, which will be infected with actual human papillomavirus.

Human Papillomavirus (HPV) infection, and the resulting genital warts, is the most prevalent sexually transmitted disease (STD) in the United States. HPV infection is extremely contagious, with approximately two-thirds of all people exposed to the virus becoming infected within a three-month period. Approximately 5.5 million new cases of sexually transmitted HPV occur in the U.S. each year, with at least 20 million people currently infected. HPV is highly prevalent in women under 30 years of age, and studies indicate that the majority of college age women are HPV positive. Of special importance is the link between HPV and cervical cancer, which causes 250,000 deaths world-wide each year. The role of HPV, as the principal agent in the etiology of cervical cancer has been clearly established. The lifetime risk of invasive cancer is 5-10% for untreated HPV infection, and if infected with one of the highly-oncogenic HPV sub-types, there is a 70% risk of progression to Cervical Dysplasia, the precursor of Cervical Cancer. There is no current antiviral treatment approved for HPV virus associated with genital warts and cervical cancer. Biokeys believes that these studies will provide further evidence that Thiovir and Thiovir analogues may be used successfully in the future as topical and oral antiviral treatments for HPV.

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. The Company's lead compound, CoFactor(TM), is a chemotherapy biomodulator designed to be used in conjunction with 5-FU, the world's most frequently used cancer drug. CoFactor is being readied to enter Phase III human clinical trials. Also in development is Eradicaide(TM), a cell mediated, antibody-negative immunotherapeutic/vaccine for HIV, which in primate studies has demonstrated the ability to reduce viral loads to undetectable levels with no development 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.
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Publication:Business Wire
Date:Dec 19, 2000
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