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[DewDiligence]

JNJ Starts Phase-3 Trials of TMC278 in Treatment-Naïve HIV

[Each trial is a head-to-head study of TMC278 vs Sustiva when added to a standard backbone regimen. In one trial, the backbone is Truvada; in the other trial, the backbone may be Truvada or Combivir or Epzicom at the investigator’s discretion. The primary endpoint in both trials is the % of patients with viral load <50 copies/mL at 48 weeks, but the trials continue treatment for 96 weeks to assess safety and resistance.

TMC278, a non-nucleoside reverse transcriptase inhibitor, is a direct competitor of IDIX’s IDX899. It should not be confused with TMC125 (Intelence), another NNRTI for HIV that is already on the market. Tibotec is a wholly-owned subsidiary of JNJ.]

http://biz.yahoo.com/prnews/080717/nyth006a.html

›Thursday July 17, 8:00 am ET

- Once-daily TMC278, the third anti-HIV compound to be developed in Tibotec virology portfolio -

YARDLEY, Pa., July 17 /PRNewswire/ -- Tibotec Pharmaceuticals Ltd. announced today that two major phase III efficacy trials examining TMC278, its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in treatment-naive adults with HIV-1, are now recruiting patients. The global trials will compare the efficacy, safety and tolerability of TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV), each coadministered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs), in treatment-naive HIV-1-infected adults.

"Preliminary data have shown TMC278 to be active against HIV for patients who have not previously received treatment," Roger Pomerantz, MD, President of Tibotec Research and Development. "These phase III studies will provide important information on the safety and efficacy of this potential new treatment."

The first phase III, double-blind, randomized study, known as TMC278-C209 or ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and EFV), will evaluate TMC278 (25 mg) once daily oral tablet versus EFV (600 mg) once daily, when combined with a fixed background regimen consisting of emtricitabine + tenofovir disoproxil fumarate [i.e. Truvada].

A second phase III, double-blind randomized study, known as TMC278-C215 or THRIVE (TMC278 against HIV, in a once daily RegImen Versus Efavirenz), will evaluate TMC278 (25 mg) once daily versus EFV (600 mg) once daily, when combined with an investigator-selected background regimen consisting of two N[t]RTIs (abacavir + lamivudine or tenofovir disoproxil fumarate + emtricitabine or zidovudine + lamivudine) [i.e. Epzicom or Truvada or Combivir].

Each study will be conducted at more than 100 sites in over 20 countries, including the U.S., Canada and several countries in Latin America, among others, and will seek to enroll approximately 680 patients. To be eligible, patients must have a viral load greater than 5,000 copies/mL at screening and may not have taken any anti-HIV drugs prior to enrolling, as well as meet other screening criteria. The primary endpoint of the studies is to assess the proportion of patients with viral load < 50 copies/mL at week 48 on TMC278 vs. control (EFV). The studies will last for 104 weeks, which includes a four-week screening period, a 96-week treatment period and a four-week follow-up period.

Results from both of these studies will be submitted to the U.S. Food and Drug Administration (FDA) for consideration for approval of TMC278.

About Tibotec Pharmaceuticals Ltd.

Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need. Tibotec is a member of the Johnson & Johnson family of companies.‹


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