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INFORM-1 Clinical Trial Amended to Further Explore Promising Direct Antiviral Regimen in HCV Patients
Date:4/21/2009

- Non-responder and Null Responder HCV patients -

- Twice-Daily Dosing and Higher Doses of ITMN-191 (R7227) -

BRISBANE, Calif., April 21 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that the innovative clinical study of protease inhibitor ITMN-191 (R7227) in combination with nucleoside polymerase inhibitor R7128 (Roche/Pharmasset), referred to as the INFORM-1 study, has been successfully amended to include additional cohorts to explore the combination in treatment-experienced and null responder HCV patients. In addition, the amended protocol now includes the administration of twice-daily and higher-dose regimens of ITMN-191 in combination with R7128 in treatment-naive patients. A description of the expanded study design can be viewed at .

Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "The first four cohorts of the INFORM-1 study successfully demonstrated that the novel combination of relatively low doses of two direct antiviral agents can be administered safely and, in the absence of interferon, result in robust antiviral activity in treatment-naive HCV patients. INFORM-1 has now been expanded to explore this novel regimen in treatment-experienced patients; both non-responder patients and so-called null responders, which together represent an important unmet medical need as their treatment options are currently very poor. The inclusion of twice-daily dosing of ITMN-191 at doses of up to 900mg, doses that were safely and effectively explored when combined with the current standard of care, is another important expansion of INFORM-1. We look forward to the results of these important new cohorts."

INFORM-1 Expanded Study Design

The expanded INFORM-1 design now includes three additional dosage cohorts
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SOURCE InterMune, Inc.
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