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InterMune to Report Top-Line Results of Triple Combination Study of ITMN-191 in January 2009
Date:12/10/2008

BRISBANE, Calif., Dec. 10 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today said that it will report top-line results in January 2009 from its Phase 1b clinical trial of protease inhibitor ITMN-191 (R7227) in combination with standard-of-care Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin) for 14 days of treatment in treatment-naive patients chronically infected with the hepatitis C virus (HCV) genotype 1. ITMN-191 is being developed in collaboration with Roche.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "We now expect to report top-line data from six dosage cohorts; three cohorts each of twice-daily and three-times-daily regimens. Although the 14-day triple combination study remains blinded at this time, and thus only limited inferences regarding safety can be made, adverse events to date have generally been mild to moderate and there have been no discontinuations during the study. Results from this study have guided the design of our planned Phase 2 program which is anticipated to begin in the first half of 2009."

Mr. Welch continued, "In addition, we are pleased to report that the first dosage cohort has been enrolled in the INFORM-1 study of ITMN-191 in combination with polymerase inhibitor R7128 (Roche/Pharmasset). INFORM-1 is the first ever study to investigate the combined effects of two direct antiviral agents in the absence of interferon in treatment-naive HCV patients. We expect results of this study to be reported at a major medical conference in the first half of 2009."

Phase 1b Triple Combination Trial Design

The Phase 1b randomized, double-blind, placebo-controlled, 14-day triple combination study in treatment-naive patients chronically infected with HCV genotype 1 was designed to inform the dose selection and study de
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SOURCE InterMune, Inc.
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