Navigation Links
InterMune Announces Progress on Pirfenidone in IPF
Date:4/21/2008

- 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

website -

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.

About IPF

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.

About Pirfenidone

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.

About InterMune

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.

Forward-Looking Statements

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.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. InterMune Provides Additional Information on ITMN-191 (R7227) MAD Study Results
2. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
3. InterMune Announces Start of Phase 1b Trial of ITMN-191
4. InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
5. Edwards Lifesciences Announces First Implants in U.S. Study of Minimally-Invasive Pulmonic Valve
6. Aida Announces New Anti-Cancer Drug Under Development
7. AlphaVax Announces Initial Analysis of Data From CMV Phase 1 Clinical Trial
8. Tepha Announces First Human Usage of Medical Devices Derived from New Class of Resorbable Polymers
9. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Moderately Infected Diabetic Foot Ulcers
10. ViroPharma Announces Discontinuation of HCV-796 Development
11. Schering-Plough Announces Imperfect Contraceptive Use Impacts Womens Emotional Well-Being
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... SPRING, Md. , Feb. 4, 2016 In ... Califf , the FDA,s Deputy Commissioner for Medical Products and ... action plan to reassess the agency,s approach to opioid medications. ... epidemic, while still providing patients in pain access to effective ... The FDA will: , Re-examine the risk-benefit paradigm ...
(Date:2/4/2016)... Mass. , Feb. 4, 2016  Blueprint ... in discovering and developing highly selective investigational kinase ... announced the appointment to its board of directors ... executive with nearly 30 years of industry-related experience. ... Officer of Blueprint Medicines. "Lonnel,s strong strategic experience ...
(Date:2/4/2016)... , Feb. 4, 2016 SONIFI™ Health, ... solutions, today announced that MonteCedro, an innovative retirement ... Engagement System. The system provides a simple and ... access through a tablet PC. ... engagement system provides access to a wide spectrum ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... 05, 2016 , ... In sleep, when the defenses of the day are ... of patients with eating disorders is significant self-criticism, and consequently these patients experience this ... regarded as maladaptive means for coping with this unease, but also leads to a ...
(Date:2/5/2016)... ... 2016 , ... California Mobile Kitchens , a company ... latest mobile kitchen model, featuring customizable stainless steel interiors and a new, 26-foot ... use anywhere in the U.S. Many of their units can be seen at ...
(Date:2/5/2016)... ... 05, 2016 , ... Calls Blacklist has just been updated by mobile app ... the developer has fixed known bugs within the app. Calls Blacklist allows its users ... not consuming any of their device’s battery power or memory. It provides a powerful ...
(Date:2/5/2016)... ... ... –This week, Atascadero water heater company First Call Plumbing has ... the report, click here or see below. , There are two ... cons, the type chosen is almost entirely up to personal preference. However, tankless water ...
(Date:2/5/2016)... ... ... one is tired of trying to cram belongings into spare space that just isn’t there, ... unit, but before hastily spending money on a unit, take these tips into consideration. , ... one is often not told when utilizing these services are some tips on how to ...
Breaking Medicine News(10 mins):