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Tibotec Starts Global Phase 3 Clinical Trials Studying TMC435 in Adults With Chronic Genotype 1 HCV
Date:2/18/2011

n-treatment measurement, and have relapsed (detectable HCV RNA) within one year of last taking medication. The primary endpoint of the studies is to assess whether TMC435 is superior to placebo in achieving sustained virologic response (SVR), defined as HCV RNA <25 IU/ml undetectable, 24 weeks after the planned end of treatment (SVR 24), with the final analysis being performed after the last patient reaches week 72 of the study. Secondary endpoints include superiority of TMC435 versus placebo at 12 weeks (SVR 12), after planned end of treatment and at week 72 of the study. Evaluations of viral breakthroughs, relapse rates in treatment groups, safety and tolerability also will be assessed.

Phase 3 studies for TMC435 also recently launched in Japan.

For additional information on inclusion and exclusion criteria for these studies, please see www.clinicaltrials.gov or email info@tibbe.jnj.com.

*Pegintron® and Rebetol® are registered trademarks of Schering Corporation, a subsidiary of Merck & Co., Inc.

*Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche, Inc.

About HCVHCV is a blood-borne infectious disease that affects the liver. With an estimated 170 million people infected worldwide and three to four million people newly infected each year, HCV puts a significant burden on patients and society. Chronic infection with HCV can lead to liver cancer and other serious and fatal liver diseases, and is the most common cause of liver transplant worldwide.  The current standard of care for HCV, pegylated interferon combined with ribavirin, causes serious side effects and only cures 40 to 50 percent of genotype 1 patients. The development of new therapies, particularly direct antivirals with different modes of action, may allow HCV patients to undergo a shorter and more effective treatment regimen.

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SOURCE Tibotec Pharmaceuticals
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