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InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF
Date:2/3/2009

DL(CO), or -- Death In the case of FVC or DL(CO), the decline must be confirmed at two consecutive visits at least 6 weeks apart. 3. Categorical assessment of absolute change from Baseline to Week 72 in percent predicted FVC 4. Change from Baseline to Week 72 in dyspnea measured by the University of California at San Diego Shortness-of-Breath Questionnaire (UCSD SOBQ) 5. Change from Baseline to Week 72 in the percent predicted Hb-corrected DL(CO) 6. Change from Baseline to Week 72 in the worst oxygen saturation by pulse oximetry (SpO2) measurement observed during the Six-Minute Walk Test 7. Change from Baseline to Week 72 in distance walked in the Six- Minute Walk Test

Regarding RECAP, all eligible patients from CAPACITY have been enrolled in this on-going open-label roll-over study from CAPACITY to evaluate the long-term safety of pirfenidone in patients with IPF.

The results of CAPACITY will be presented at the 2009 International Conference of the American Thoracic Society (ATS) in San Diego, and InterMune plans to publish the results of CAPACITY in a peer-reviewed journal.

About Pirfenidone

Preclinical and in-vitro evidence had shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Prior to the current results, data were presented from one Phase 3 study and four Phase 2 clinical trials in more than 400 patients which suggested that pirfenidone may positively affect lung function and disease progression in patients with IPF. In those clinical studies, pirfenidone was generally safe and well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. In October of 2008, pir
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SOURCE InterMune
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