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Results of Comprehensive Safety Analysis of pirfenidone In IPF Patients Presented At European Respiratory Meeting
Date:9/14/2009

VIENNA, Sept. 14 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that the results of a comprehensive review of safety data from four clinical studies were presented at the 2009 European Respiratory Society Annual Congress in Vienna, Austria by Dr. Ulrich Costabel of the Ruhrlandklinik, Essen, Germany.

In order to assess the risk-benefit profile of pirfenidone in IPF patients, a comprehensive review of safety was conducted involving two Phase 3 trials (CAPACITY 1 and CAPACITY 2) and two open-label studies (RECAP and PIPF-002). RECAP is an on-going open-label extension study that enrolled 603 patients who completed CAPACITY. PIPF-002 is an on-going long-term, open-label study in 83 IPF patients.

The summary and conclusions from the safety analysis as presented at ERS were:

  • A comprehensive review of safety data from four clinical studies showed that treatment with pirfenidone was safe and generally well tolerated
  • In the CAPACITY studies:
  • The majority of adverse events (AE) were mild to moderate in nature and relatively few patients discontinued treatment due to adverse events.
  • A similar incidence of serious adverse events (SAE) was observed in the pirfenidone group relative to the placebo group
  • Fewer deaths were observed in the pirfenidone group relative to the placebo group and this difference was driven by a reduction in IPF-related deaths
  • GI and skin AE were more common in pirfenidone-treated patients and were generally mild to moderate, transient, and rarely led to treatment discontinuation
  • Transaminase (liver enzyme) elevations were slightly more common in the pirfenidone group, generally low-grade and without clinical sequ
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SOURCE InterMune, Inc.
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