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[DewDiligence]

GILD HIV-Integrase Inhibitor Non-Inferior to PI’s

[This phase-2 trial compared GS9137 to an “investigator’s choice” PI, each in conjunction with a standard HIV backbone such as Truvada. The primary endpoint was met, but only for the highest of three tested doses and, even there, only if no Hochberg adjustment is applied. (The lowest dose has been discontinued.) GS9147 is in competition with MK-0518 from MRK to be the first integrase inhibitor approved for HIV.]

http://biz.yahoo.com/bw/070223/20070223005621.html?.v=1

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Gilead Announces Completion of Phase II Clinical Trial of Novel Investigational HIV Integrase Inhibitor GS 9137

Friday February 23, 4:00 pm ET

Study Meets Primary Endpoint of Non-inferiority

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD ) today announced the completion of a Phase II clinical trial of GS 9137, a novel oral HIV integrase inhibitor. The clinical study met its primary endpoint of non-inferiority in viral load reduction in HIV-positive patients receiving 50 mg or 125 mg of GS 9137 once daily, each boosted with 100 mg of ritonavir, in combination with an optimized background antiretroviral regimen compared to a boosted comparator protease inhibitor regimen (p=0.02 for the 125 mg arm).

This ongoing Phase II study is a partially-blinded, randomized, active-controlled, 48-week clinical trial to evaluate the non-inferiority of once-daily GS 9137 versus boosted comparator protease inhibitors (CPI/r) in highly treatment-experienced HIV-infected patients. After week eight, the GS 9137 20 mg arm was closed due to a high rate of virologic failure. At this time, the addition of darunavir or tipranavir to the GS 9137 study arms was permitted, following the availability of data demonstrating a lack of drug interactions between both protease inhibitors and GS 9137. The primary endpoint of the study was DAVG24, a measure of viral load reduction over 24 weeks.

Integrase inhibitors are an investigational class of antiretrovirals that interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Novel classes of HIV-fighting drugs are needed as patients live longer and exhaust currently available treatment options.

About GS 9137

GS 9137, also known as JTK-303, was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of the company's agreement with JT, Gilead has exclusive rights to develop and commercialize GS 9137 in all countries of the world, excluding Japan where JT retains rights. As an investigational compound, GS 9137 has not yet been determined safe or efficacious in humans for its ultimate intended use.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
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