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www.fdanews.com/articles/83281-tibotec-reports-phase-iib-data-on-investigational-hiv-compounds

TIBOTEC REPORTS PHASE IIB DATA ON INVESTIGATIONAL HIV COMPOUNDS

December 20, 2005

Tibotec Pharmaceuticals has reoprted primary 24-week efficacy and safety results from the POWER 2 trial on TMC114, a protease inhibitor (PI), in treatment-experienced patients and the first long-term clinical results of TMC125, a non-nucleoside reverse transcriptase inhibitor (NNRTI) in HIV-1 patients with NNRTI resistance. Both TMC114 and TMC125 are currently being studied in Phase III trials.

Study results showed that 62 percent of patients achieved a reduction in viral load of 1 log10 or more in the highest TMC114/r dose group, 600mg/100mg BID, compared to 14 oercent in the control group. A total of 278 patients were randomized to receive optimized background regimen plus one of four doses of TMC114/r.

At 24 weeks, the percentage of patients reaching undetectable virus levels was 39 percent in the highest TMC114/r dose group compared with 7 percent in the control arm. This study will continue to 144-weeks.