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New HIV Protease Inhibitor at 13th Intl HIV Resistance Workshop
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I just arrived at the Resistance Workshop in Tenerife, Canary Islands, Spain. From a quick look at the program book here are what appears to me to be some of the interesting new information being presented here for discussion among leading HIV researchers.
Resistance information on this new protease inhibitor VX-385 or GW640385.
AG-001859, a new protease inhibitor from Pfizer; study here discusses it's resistance profile.
A discussion about resistance & integrase inhibitors by Merck.
Resistance and BMS-488043, an HIV attachment inhibitor.
Resistance and UK-427,857, Pfizer's CCR5 entry inhibitot/antagonist.
Continued discussion of resistance issues related to tenofovir, abacavir, 3TC, DDI, and combinations of these nukes; and these related HIV drug mutations-- K65R, M184V, L74V.
This press release was sent out today & forwarded to you for your information.
"Investigational Protease Inhibitor 640385 (VX-385) from GSK and Vertex Indicates Activity Against HIV, Including Protease Inhibitor-Resistant Strains"
LONDON, June 8 /PRNewswire-FirstCall/ -- GlaxoSmithKline and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data for an investigational Protease Inhibitor (PI) 640385 (VX-385) which appears to be active against HIV, including strains that have become resistant to multiple protease inhibitor drugs, at the XIIIth International HIV Resistance Workshop. Data were presented in two abstracts for 640385, an aspartyl protease inhibitor (PI) that is currently in Phase I clinical trials, including in vitro evaluations to determine what mutations might lead to resistance when tested in the clinic. Based on these in vitro experiments, 640385 appears to select for a mutation at A28S, which has not been reported for any of the currently marketed PIs. The significance of this finding will need to be confirmed in clinical trials. "These continued findings on the understanding of the resistance patterns for 640385 will aid in the development of the molecule and help in the development of new options for HIV patients," said Ken Batchelor, Senior Vice-President, Metabolic and Viral Diseases, Drug Discovery at GlaxoSmithKline.
"Resistance remains a critical issue in the field of HIV, and GSK is committed to discovering new medicines to meet this need." In a second study, data presented from an in vitro experiment suggested patients who experienced virologic failure while taking an amprenavir or fosamprenavir-containing regimen could potentially benefit from 640385. In this in vitro evaluation, a panel of clinical isolates from patients who had been on a regimen that included amprenavir/fosamprenavir and failed were tested for resistance to 640385 and amprenavir/fosamprenavir. Only 10% (3/30) of the clinical isolates evaluated had greater than three fold change (FC) in susceptibility to 640385. Two of these three isolates had the I54L/M +I84V mutations and one had the I50V. Although I54L/M+I84V mutations may contribute to decreased 640385 susceptibility, it was found that I54L/M mutations in the absence of I84V, and conversely I84V mutations in the absence of I54L/M and V32I+I47V do not appear to be associated with 640385 resistance.
Similarly, the I50V mutation did not appear to be associated with 640385 resistance. The clinical significance of resistance data is under evaluation. This compound was jointly discovered by GSK and Vertex Pharmaceuticals. GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies and an industry leader in HIV research and therapies. The company is engaged in basic research programs to investigate new targets to treat HIV.
Definition of Fold Change (FC): The increase in drug concentration required to inhibit a resistant virus.
About Vertex Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The Company's strategy is to commercialize its products both independently and in collaboration with major pharmaceutical partners. Vertex's product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes two HIV protease inhibitors with GlaxoSmithKline.
Vertex Safe Harbor Statement This press release may contain forward-looking statements, including statements that VX-385 could be active against certain resistant HIV strains, and that VX-385 could therefore be beneficial to patients who experienced virologic failure while taking amprenavir/fosamprenavir. While management makes its best efforts to be accurate in making forward-looking statements, such statements are subject to risks and uncertainties that could cause Vertex's actual results to vary materially, including the risk that laboratory results may not be duplicated in a clinical setting, and other risks and uncertainties listed under Risk Factors in Vertex's form 10-K filed with the Securities and Exchange Commission on March 15, 2004.
Vertex's press releases are available at www.vrtx.com.
Vertex Contacts:
Lynne Brum, Vice President, Corporate Communications and Financial
Planning (617) 444-6614
Michael Partridge, Director, Corporate Communications (617) 444-6108
Lora Pike, Manager, Investor Relations (617) 444-6755
SOURCE Vertex Pharmaceuticals Incorporated
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