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Gilead Science's GS9137 HIV therapy reaches phase 2 trial
By Lisa Kerner
Erie, Pa., Jan. 9 - Gilead Sciences, Inc. has completed a phase 1/2 study of GS 9137 (or JTK-303), an oral HIV integrase inhibitor and now plans to begin a phase 2 trial.
The phase 1/2 study evaluated the tolerability, safety and antiviral activity of GS 9137 in HIV-positive patients.
Based on the results of this study, Gilead anticipates evaluating three once-daily doses for GS 9137 (20 mg, 50 mg and 125 mg), each boosted with ritonavir 100 mg. The trial is slated to begin by June.
In the phase 1/2 study, a significant viral load reduction was observed in HIV-infected patients. The 50 mg dose, in combination with ritonavir, showed antiviral activity similar to the most potent protease inhibitors.
"The development of therapies targeting new steps of the HIV lifecycle such as integrase is critical, particularly for treatment-experienced patients with limited options," said Norbert Bischofberger, Gilead's executive vice president of research and development, in a news release. "We are working quickly to finalize the protocol design so that we may initiate larger phase 2 and phase 3 studies."
Gilead licensed GS9137 from Japan Tobacco in March 2005. Under the terms of the licensing agreement, Gilead has exclusive rights to develop and commercialize GS 9137 in all countries of the world, except Japan. GS 9137 was evaluated in a phase 1 study in Japan to assess pharmacokinetics and safety in healthy volunteers.
Gilead Sciences, based in Foster City, Calif., is a biopharmaceutical company that develops therapeutics to advance the care of patients suffering from life-threatening diseases.
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