Aug. 27, 2012
/PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced that an oral presentation and three poster presentations related to the company's research programs in idiopathic pulmonary fibrosis (IPF) will be presented at the Annual Congress of the European Respiratory Society (ERS) being held in
New analyses of FVC change and Survival from the RECAP extension study of Esbriet
(pirfenidone) will be delivered in an oral presentation. Additionally, new data on the long-term clinical safety of Esbriet in IPF patients who have received treatment for up to 7.7 years will be presented as part of a scientific poster discussion.
, Chairman, Chief Executive Officer and President of InterMune, said, "These data demonstrate that the safety profile of Esbriet in IPF patients treated for several years is generally consistent with the well characterized safety profile from previous clinical studies. Importantly, Esbriet is the first and only agent to demonstrate long-term clinical safety in a prospective well-designed study in patients with IPF."
Two additional scientific posters, including an analysis of safety outcomes in IPF patients treated with Esbriet and commonly used concomitant medications and the results of analyses that confirm the threshold defining clinically significant changes in the 6-minute walk test in patients with IPF will also be presented.
The schedule of presentations regarding Esbriet and/or IPF at ERS is as follows (all times CET):
Sunday, September 2, 2012
2:50-14:40 hThematic Poster Presentation Dr.
Safety and Tolerability of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis Receiving Commonly Used Concomitant Medications"
Location: Hall A11/P718
Monday, September 3, 2012
14:45 - 16:45 hOral PresentationDr.
Analysis of Lung Function and Survival in RECAP: An Open-label Extension Study of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis"
Location: Oral Presentation OP2820/Hall A3
Tuesday, September 4, 2012
08:30 - 10:30 hPoster DiscussionDr.
The Long-term Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis: Integrated Analysis of Safety from Four Clinical Trials"
Location: Hall A5/P3159
12:50 - 14:40 hPoster PresentationDr.
6-Minute Walk Test in Patients with Idiopathic Pulmonary Fibrosis: Confirmation of the Minimal Clinically Important Difference"
Location: Hall A13/P3656
RECAP is an open-label extension study for patients who participated in the Phase 3 program for Esbriet, known as CAPACITY. The CAPACITY program (studies 004 and 006) was designed to evaluate the safety and efficacy of Esbriet in IPF patients with mild to moderate impairment in lung function. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96 percent) were enrolled in RECAP.
Long-term safety results from RECAP were initially presented at the Annual Congress of the European Respiratory Society (ERS) in September 2011. These results demonstrated that long-term treatment with Esbriet was safe and generally well-tolerated, with a long-term safety profile similar to that observed in CAPACITY.