- Initiating planned roll-over study for CAPACITY patients in Q3 -
- Patient retention and conduct of Phase 3 CAPACITY program remain
excellent to date - - Abstract of Shionogi Phase 3 pirfenidone study now available on ATS
BRISBANE, Calif., April 21 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced that it will initiate an open-label roll-over study to evaluate the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). The roll-over study will be open to patients who complete one of the two concurrent Phase 3 CAPACITY studies of pirfenidone in IPF. InterMune expects that the first patient will enter the roll-over study in August 2008. Additional information regarding the design and objectives of the pirfenidone roll-over study will be available at http://www.clinicaltrials.gov within approximately one week. The anticipated 2008 costs of conducting the study are included in InterMune's expense guidance of February 7, 2008.
Regarding the progress of CAPACITY, the company noted that patient retention and overall study conduct remain excellent, with a low rate of patient dropouts to date. InterMune anticipates that top-line results from CAPACITY will be available in January 2009. Data from the CAPACITY trials will remain blinded during the extension study enrollment period.
The company also provided an update on the publication plans of Shionogi concerning its Phase 3 study of pirfenidone in IPF performed in Japan. The abstract of the Tuesday, May 20 presentation by Shionogi of the results of this study at the American Thoracic Society (ATS), entitled, "A Phase III, Double-Blind, Placebo-Controlled Clinical Trial of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis in Japan" [Session C95], is now posted at http://www.thoracic.org.
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects a total of approximately 200,000 people in the United States and Europe, with approximately 30,000 new cases developing in the United States alone, each year. There are no medicines approved by the U.S. Food and Drug Administration (FDA) or European Medicines Evaluation Agency (EMEA) for the treatment of IPF. IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years.
Prior in vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Data presented from one Phase 3 study and four Phase 2 clinical trials in more than 400 patients suggest that pirfenidone may positively affect lung function and disease progression in patients with IPF. In these clinical studies, pirfenidone was generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. Pirfenidone has been granted orphan drug designation in the both the United States and Europe for the treatment of IPF.
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a research and development portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com.
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the SEC on March 14, 2008 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; (iii) risks related to timely patient enrollment and retention in clinical trials; and (iv) risks that the results of the InterMune CAPACITY trials of pirfenidone may differ materially from those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at http://www.intermune.com.
|SOURCE InterMune, Inc.|
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