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InterMune Reports Presentation of Triple Combination Study of ITMN-191 at European Association for the Study of the Liver (EASL)
Date:4/24/2009

ITMN-191 was generally safe and well tolerated. There were no serious adverse events (SAE) or Grade 4 adverse events (AEs) during treatment with ITMN-191. AEs reported during study treatment (ITMN-191 or placebo) were predominantly mild to moderate in severity, typically consistent with the well-described AE profile of standard of care (SOC) and none led to treatment discontinuation.

Only four Grade 3 AEs were reported during study treatment, two of which (sciatica and back pain) were deemed by the investigator to be unrelated to ITMN-191. The other two were neutropenia and indirect bilirubin elevation. Neutropenia occurred with a similar pattern, frequency and severity in the placebo and ITMN-191 groups. Minor and transient elevations in indirect bilirubin levels were observed in a small number of placebo and ITMN-191 patients and were deemed not clinically significant by the investigator. There were no other laboratory or ECG findings during study treatment that were attributable to ITMN-191.

Phase 1b Triple Combination Trial Design

The Phase 1b randomized, double-blind, placebo-controlled, 14-day triple combination study was conducted in treatment-naive patients chronically infected with HCV genotype 1. The study objectives were to assess the safety, pharmacokinetic and viral kinetic effects of various doses and regimens of ITMN-191 for 14 days in combination with Pegasys and Copegus compared to treatment with Pegasys and Copegus alone. Patient follow-up continued for 30 days following the completion of study treatment.

INFORM-1 Program

In November 2008, Roche, InterMune and Pharmasset initiated the first all-oral combination study of direct-acting antivirals (DAAs) in the absence of interferon or ribavirin, known as the INFORM-1 study. Interim results from the INFORM-1 study will be presented in an oral late-breaker session of the EASL meeting on Satur
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SOURCE InterMune, Inc.
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1. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
2. InterMune Announces Start of Phase 1b Trial of ITMN-191
3. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
4. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
5. InterMune Announces Progress on Pirfenidone in IPF
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8. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
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