Gilead announces GS 9137 Ph I/II study data

Los Angeles, USA-based Gilead Sciences says that the results of a Phase I/II dose-escalation study of its developmental product GS 9137, also referred to as JTK-303, its oral HIV integrase inhibitor, demonstrate that the drug produces a significant reduction in viral load among HIV-positive patients receiving it as a monotherapy, or in combination with ritonavir, when compared with placebo. The data was presented at the 13th Conference on Retroviruses and Opportunistic Infections held, this year in Denver, Colorado, USA.

The drug was originally developed by Japan Tobacco, and was licensed by the US firm last year (Marketletter March 28, 2005), under a deal which allows it to develop and commercialize the product outside Japan.

The trial was a double-blind, randomized, placebo-controlled monotherapy designed to evaluate the safety, tolerability and antiviral activity of the compound in HIV-infected patients. The program enrolled 40 subjects who were randomized to receive one of five different doses of the drug. The primary efficacy endpoint was the maximum reduction in viral load from a mean baseline of 4.75log10 copies per milliliter.