GSK, SHIONOGI COMPLETE STUDY OF HIV INTEGRASE INHIBITOR

GlaxoSmithKline (GSK) and Shionogi announced they have completed an initial clinical study in humans with an investigational integrase inhibitor, 364735, which is being developed for the treatment of HIV/AIDS. Integrase inhibitors are a new class of anti-HIV drugs that block viral replication by preventing the virus from integrating into the genetic material of human immune cells.

The Phase I study was conducted in the United States to assess safety and pharmacokinetics in healthy volunteers. Data from this study of 364735 have enabled selection of doses for a Phase II study, the next step in its clinical development, which is planned to start in late 2006 in HIV-infected adults.

The integrase enzyme is unique to the virus and is not found in humans, which makes it an attractive drug target. New treatments are critical for HIV treatment-experienced patients who have exhausted other available options. These patients need new drugs with improved safety profiles that can be administered in combination to attain a high degree of viral suppression against drug-resistant virus.