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PRESS RELEASES Biokeys Pharmaceuticals, Inc. commences manufacturing of BlockAide/CR™ Company Seeks to Duplicate Preclinical success in third quarter Phase Ib/IIa HIV Clinical Trial SAN DIEGO – June 11, 2003 – Biokeys Pharmaceuticals, Inc. (OTCBB:BKYS - News) announced today that it has initiated manufacturing of its viral entry inhibitor for HIV, known as BlockAide/CR, in order to prepare pharmaceutical grade product to dose HIV infected patients in a Phase Ib/IIa human clinical trial, which the Company plans to implement in the third quarter this year. "Manufacturing of BlockAide/CR is being conducted for us by Multiple Peptide Systems (MPS) of San Diego, California in its newly dedicated facilities, which have been designed for large-scale GMP peptide manufacturing," said Dr. Joan Robbins, Biokeys Pharmaceuticals' Chief Technical Officer. " We are pleased to work with MPS as one of our key manufacturing partners to further the development of our lead HIV drug." BlockAide/CR is a synthetic peptide drug, based upon the structure of the V3 loop of HIV, which the virus uses to bind to cell surface lipids as part of its infection process before viral fusion takes place. BlockAide/CR competitively inhibits the interaction of the V3 loop with host cell lipids, which is a common mechanism for entry and infection of diverse HIV-1 strains, and thus prevents infection of treated immune system cells. In preclinical development, 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 100-fold after approximately two weeks of treatment, with no observed toxicity. Based upon the success of this efficacy testing and the completion of toxicity studies in four non-human animal models, as well as the newly implemented manufacturing of drug product for human testing, the Company is completing its IND (investigation new drug application) for submission to FDA to gain approval to begin the human trials. About Multiple Peptide Systems Multiple Peptide Systems is a privately held company, based in San Diego, California, specializing in custom research and pharmaceutical grade peptides, antipeptide antibodies, bioactive peptides, modified amino acids, building blocks and turn mimics. The company's new facilities were licensed by the State of California to manufacture GMP peptides for Drug and Device applications in September 2002. MPS has been registered with FDA since 1990 and audited four times without major observations. MPS is part of GROUPE SNPE (Paris, France). About Biokeys Pharmaceuticals 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: 858/271-9678 virca@bkys.com CEOCast, Inc. for Biokeys Pharmaceuticals Mathew Henderson, 212/732-4300 Fax: 212/732-1131 mhenderson@ceocast.com |
