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Tibotec Starts Global Phase 3 Clinical Trials Studying TMC435 in Adults With Chronic Genotype 1 HCV

Fri, 02/18/2011 - 1:35am
Bio-Medicine.Org

CORK, Ireland, Feb. 18, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals announced today that two global, registrational phase 3 trials are recruiting patients to examine TMC435, its investigational hepatitis C protease inhibitor, in treatment-naive adults with chronic genotype 1 hepatitis C virus (HCV). A third global phase 3 trial is being conducted in genotype 1 HCV patients who have experienced a viral relapse after prior interferon-based treatment. Approximately 3.2 million people in the U.S. live with chronic hepatitis C disease and more than 170 million people have the disease globally. The response-guided trials will compare the efficacy, safety and tolerability of TMC435 given as a single 150 mg oral tablet once daily for 12 weeks versus placebo; each patient also will be treated with a background regimen of peginterferon and ribavirin for 24 or 48 weeks.

"TMC435 is an important component of our growing HCV pipeline," said Brian Woodfall M.D., Vice President of Global Clinical Development at Tibotec. "The initiation of the TMC435 phase 3 clinical trial program reinforces our commitment to develop innovative new treatment options that may decrease the duration of treatment for patients with chronic hepatitis C infection."

The first global, phase 3, double-blind, randomized study, known as TMC435-C208 or QUEST-1 (QD dosing of TMC435 of previoUsly untreated GEnotype 1 patienTs-1), will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. Both groups will also receive peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) as part of their treatment. The second global, phase 3, double-blind, randomized study, known as TMC435-C216 or QUEST-2 (QD dosing of TMC435 of previoUsly untreated GEnotype 1 patienTs-2), also will evaluate a single TMC435 once-daily oral tablet (150 mg) versus placebo in treatment-naive HCV patients. However,

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