BRISBANE, Calif., Nov. 9 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced that it has enrolled the 600th patient in its pivotal Phase III INSPIRE clinical trial almost two months ahead of schedule. The randomized, double-blind, placebo-controlled INSPIRE trial, designed to determine if Actimmune(R) (interferon gamma-1b) decreases mortality in patients with idiopathic pulmonary fibrosis (IPF), is scheduled to conclude approximately two years after the 600th patient enrolls, or around the end of 2007.
“We are very pleased to reach this important milestone ahead of the original schedule we set when we launched this pivotal trial in late 2003,” said Dan Welch, President and CEO of InterMune. “In addition to strong enrollment in INSPIRE, we’ve seen a high rate of treatment adherence and a low number of patient discontinuations. We expect INSPIRE to end in approximately two years, with top line data available in early 2008, as originally planned.”
Last month, InterMune announced its decision, based on pre-specified criteria in the study protocol, to enroll an additional 200 patients in the trial to increase the likelihood of observing the planned number of total events prior to the time the trial is scheduled to conclude. Since the end of the trial is tied to the enrollment of the 600th patient, enrolling the additional 200 patients will not increase the trial duration. InterMune anticipates enrollment of the 800th patient in the first half of 2006.
The trial is currently enrolling at approximately 80 sites in North America and Europe. Information for patients and healthcare providers can be found at www.inspiretrial.com.
About IPF
IPF is a disabling and ultimately fatal disease that affects approximately 83,000 people in the United States, with an estimated 35,000 new cases developing each year. Those diagnosed with IPF are usually between the ages of 50 and 70, and the disease tends to affect men more than women. IPF causes inflammation and scarring (fibrosis) in the lungs, hindering a person’s 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. Median survival time from diagnosis is three to five years in patients with IPF. There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMEA) for the treatment of IPF.
About Actimmune(R)
Interferon gamma is a naturally occurring protein that stimulates the immune system. InterMune markets Actimmune(R) for the treatment of two life-threatening congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. The most common side effects are flu-like symptoms, including headache, fatigue, fever, chills, and rash. InterMune is conducting two late-stage trials of Actimmune(R): the INSPIRE Trial, a Phase III study of interferon gamma-1b in IPF, and the GRACES Trial, a Phase III study of interferon gamma-1b in ovarian cancer. InterMune was recently granted two composition of matter patents related to interferon gamma-1b in the United States, extending its patent protection until 2022. Physicians and patients can obtain additional prescribing information regarding Actimmune(R), including the product’s safety profile, by visiting www.actimmune.com
About InterMune
InterMune is a biopharmaceutical company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a broad and deep late-stage product portfolio addressing IPF and hepatitis C virus (HCV) infections, particularly nonresponders, or those patients who do not respond to first-line therapy. The pulmonology portfolio includes Actimmune(R) and pirfenidone. Actimmune(R) is being evaluated in the INSPIRE Trial, a Phase III study in patients with IPF. Pirfenidone is also being developed for the treatment of IPF. In addition to three-times-a-week Infergen(R) (interferon alfacon-1), a currently marketed product indicated for the treatment of chronic HCV infections, the hepatology portfolio includes the DIRECT Trial, a Phase III study of daily Infergen(R) plus ribavirin in non-responders. Additionally, InterMune is developing a pre-clinical stage small molecule program targeted at the HCV protease. For additional information about InterMune and its development pipeline, please visit www.intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of our clinical trials and announcements of results thereof. 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 quarterly report on Form 10-Q filed with the SEC on November 7, 2005 (the “Form 10-Q”) and other periodic reports filed with the SEC, including the following: (i) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (ii) risks related to achieving positive clinical trial results and (iii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues. 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-Q and InterMune’s other periodic reports filed with the SEC.
InterMune, Inc.
CONTACT: investors, Judy Hayes of InterMune, Inc., +1-415-466-2242, orir@intermune.com; or media, Pam Lord, Atkins + Associates, +1-858-527-3494,or plord@irpr.com, for InterMune
Web site: http://www.intermune.com/
