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PRESS RELEASES Research study discloses evidence that Biokeys Pharmaceuticals' viral entry inhibitor therapeutically targets diverse HIV-I strains SAN DIEGO – March 18, 2003 – Biokeys Pharmaceuticals, Inc. (OTCBB:BKYS - News) announced today that its HIV viral entry inhibitor, BlockAide/CR™ (R15K), which is being readied for human trials, appears to be interfering with an HIV infection step common to the entry of diverse HIV-1 strains. BlockAide/CR was first identified and subsequently developed by scientists at The University of Texas M.D. Anderson Cancer Center for its anti-HIV properties. This drug is licensed to Biokeys Pharmaceuticals by M.D. Anderson on an exclusive, worldwide basis. The Company also has an exclusive, worldwide license from the National Institutes of Health (NIH) regarding composition of matter for this same compound. A new study, which appeared in the journal, Antiviral Research 56 (2002) 233-251, titled, "A post-CD4-binding step involving interaction of the V3 region of viral gp120 with host cell surface glycosphingolipids is common to entry and infection by diverse HIV-1 strains; by Nehete, Vela, Hossain, Sarkar, Yahi, Fantini and Sastry", indicated that testing conducted by M.D. Anderson scientists, in collaboration with scientists at the Mediterranean Research and Nutrition Institute in Marseilles, France, suggests that a critical V3-mediated post-CD4-binding event involves glycosphinogolipid (GSL) interaction that can be inhibited by a 15 amino acid V3 synthetic peptide, known as R15K (BlockAide/CR). This drug showed inhibition of infection by both T-cell- and macrophage-tropic strains of human immunodeficiency virus type I binding to three distinct cell surface GSL: GM3, Gb3 and GalCer. Further, it inhibited GSL binding of gp120 from both HIV-I IIIB (X4, Gb3-binding strain) and HIV-1 89.6 (X4R5, GM3-binding strain). (See the Company's website, at www.bkys.com, for more information on this article.) Dr. M. Ross Johnson, Chairman of the Board and Director of Biokeys Pharmaceuticals, and former CEO of Trimeris (NASDAQ:TRMS) which is developing viral entry inhibitor Fuzeon™, commented that "We believe that the mode of action of BlockAide/CR, which inhibits HIV interaction with GSL in the lipid raft on immune system cells, could be broad in its application to HIV therapy." In a separate trial at M.D. Anderson Cancer Center, BlockAide/CR was administered in daily doses to determine the effectiveness of this drug against acute infection with SHIV (simian human immunodeficiency virus) in an animal model. Viral load decreased nearly 100 fold after approximately two weeks of treatment, with no observed toxicity. Based upon the success of this testing, the Company intends to apply for approval to begin human testing of this drug during the second half of 2003. About BKYS 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. Contact: Biokeys Pharmaceuticals Inc. Nicholas J.Virca, 858/271-9671 Fax: 8581/271-9678 virca@bkys.com |
