To: scaram(o)uche who wrote (317 ) 9/27/1999 5:53:00 PM From: scaram(o)uche Read Replies (1) | Respond to of 1169
Monday September 27, 2:43 pm Eastern Time Company Press Release SOURCE: Vertex Pharmaceuticals Incorporated Data Presented at Medical Conference on VX-175/GW433908, An HIV Protease Inhibitor Prodrug -- VX-175/GW433908 Evaluated in First Human Study -- SAN FRANCISCO, Sept. 27 /PRNewswire/ -- Early data reported for the first time today suggest that VX-175/GW433908, the prodrug of the HIV protease inhibitor amprenavir, is a candidate for further clinical evaluation. Three reports on VX-175/GW433908 covering the design of the compound, preclinical and early clinical studies were presented here today at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). A prodrug is an inactive compound that is changed metabolically by the body to become active against disease. VX-175/GW433908 was first synthesized at Vertex Pharmaceuticals as part of a research collaboration with Glaxo Wellcome. VX-175/GW433908 is an investigational drug being developed by Glaxo Wellcome as part of an ongoing agreement between the two companies. ''Developing a prodrug of an active compound is sometimes a useful method for creating a compact formulation,'' said Roger Tung, Ph.D., Vice President of Chemistry at Vertex and a co-inventor of the prodrug. ''The development of this prodrug VX-175/GW433908 demonstrates Vertex's and Glaxo Wellcome's ongoing commitment to the fight against HIV and AIDS.'' Preclinical studies showed the prodrug to be highly water-soluble and bioavailable in animals. In a recently completed Phase I study of 16 healthy volunteers, the pharmacokinetic profile of VX-175/GW433908 was assessed together with the effect of a high fat meal on absorption. The prodrug formulation was found to be bioequivalent to amprenavir and also showed dose- proportionality. In this study, VX-175/GW433908 also delivered plasma drug levels equivalent to the recommended dose of amprenavir. A dose-ranging Phase II clinical study to assess preliminary safety and efficacy and to help determine pharmacokinetics in HIV patients is now getting underway to determine the optimal dose of VX-175/GW433908. Vertex Pharmaceuticals Incorporated is engaged in the discovery, development and commercialization of novel, small molecule pharmaceuticals for the treatment of diseases for which there are currently limited or no effective treatments. The Company is a leader in the use of structure-based drug design, an approach to drug discovery that integrates advanced biology, biophysics, chemistry and information technologies. The Company is concentrating on the discovery and development of drugs for the treatment of viral diseases, cancer, autoimmune and inflammatory diseases, and neurodegenerative diseases. There can be no assurance that clinical trials of VX-175/GW433908 will continue, that initial clinical trial results will be predictive of any future results, that drugs under development by the Company or its partners will receive marketing approval from the U.S. Food and Drug Administration or other regulatory authorities, or that drugs, if any, which receive such approval will be marketed successfully. Investors are also directed to consider other risks and uncertainties discussed in documents filed with the Securities and Exchange Commission. Additional Vertex contacts: In San Francisco: Michael Partridge, Manager, Product Communications 617-571-6108 In Cambridge: Michele Karpf, Manager, Product Communications 617-577-6259 Vertex's press releases are also available by fax-on-demand at 800-758-5804 - Code: 938395 SOURCE: Vertex Pharmaceuticals Incorporated