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Important Data Presented on Independent Predictors of Mortality in Patients With Idiopathic Pulmonary Fibrosis
Date:5/17/2009

InterMune, said, "We view the results of this study as clinically important and supportive of the results from our Phase 3 CAPACITY program, in which the primary endpoint was change in percent predicted FVC."

The analysis in the du Bois study employed longitudinal data from two large prospective clinical trials in patients with IPF. A total of 1,099 well-characterized patients who participated in the GIPF-001 and GIPF-007 (INSPIRE) trials were included in the analysis. In addition to a comprehensive multivariate model that considered all potential predictors of one-year mortality, researchers developed a practical model based on widely available and reliable measures, including FVC change, that can be used in the clinical setting to assess the near-term risk of death in patients with IPF. Dr. du Bois added, "What the practicing clinician needs is an index that is simple to apply in the office and that predicts likely outcome for an individual patient over the short term. To be able to add this information into the risk/benefit equation for that individual patient will allow a more informed management strategy to be defined. This study has provided such an index."

About the CAPACITY Program

InterMune has reported the results of two concurrent, randomized, double-blind, placebo controlled, Phase 3 trials, known as CAPACITY 1 and CAPACITY 2, evaluating the safety and efficacy of pirfenidone for the treatment of patients with IPF. In CAPACITY 2, treatment with pirfenidone resulted in a statistically and clinically significant reduction in the loss of forced vital capacity (FVC) and increase in progression-free survival time. In CAPACITY 1, the difference between pirfenidone and placebo in FVC change at week 72 was not statistically significant; however, the overall results were consistent with those of CAPACITY 2, suggesting a treatment benefit. Treatment with pirfenidone was safe and generally well tolerated;
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SOURCE InterMune, Inc.
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