Healthcare Industry News: INSPIRE trial
News Release - April 27, 2006
InterMune Initiates Phase III Program Evaluating Pirfenidone in Patients With IPFBRISBANE, Calif., April 27 (HSMN NewsFeed) -- InterMune, Inc. (Nasdaq: ITMN ) today announced that patient enrollment has begun in CAPACITY, the Company's Phase III clinical program to evaluate pirfenidone, a small molecule p38-gamma inhibitor, as a treatment for patients with idiopathic pulmonary fibrosis (IPF). CAPACITY includes two multinational, randomized, double-blind, placebo controlled Phase III trials, named CAPACITY 1 and CAPACITY 2, designed to evaluate the safety and efficacy of pirfenidone in IPF patients with mild to moderate impairment in lung function. The primary endpoint of both trials is lung function, as measured by change in forced vital capacity (FVC). The two trials will enroll a total of approximately 580 patients at over 120 centers in North America and Europe.
Patients in CAPACITY 1 will be randomized at a ratio of 1:1 to receive either three 267 milligram (mg) capsules of pirfenidone three times per day (TID) or a placebo equivalent. Patients in CAPACITY 2 will be randomized at a ratio of 2:1:2 to receive either three 267 mg capsules of pirfenidone TID, three 133 mg capsules of pirfenidone TID or placebo equivalent. All patients will receive treatment for 60 weeks and will then be followed for an additional four weeks. Information regarding the trials can be found at www.capacitytrials.com.
The primary endpoint of lung function, as measured by change in FVC, has been supported in several Phase II studies, including one conducted by Shionogi & Company, LTD. That study was terminated early based on a positive treatment effect. In a peer-reviewed article published in the May 2005 issue (vol. 171) of the American Journal of Respiratory and Critical Care Medicine, the Shionogi study authors reported that pirfenidone significantly reduced the rate of decline in lung capacity and decreased the frequency of acute exacerbations in patients with IPF.
"IPF is a disease with a five-year survival rate that is lower than many cancers. Sadly, there are currently no approved therapies for IPF. Therefore, the initiation of CAPACITY marks an important milestone in the development of potential treatment options for patients with this deadly disease, and clinicians and their patients anxiously await the results of this Phase III program," stated Paul Noble, MD, Professor of Medicine, Yale University School of Medicine and co-chair of the CAPACITY program Steering Committee.
Recent preclinical research conducted by InterMune found pirfenidone inhibits the kinase p38-gamma in vitro, and further work in these models demonstrates this inhibitory activity may be associated with the anti-fibrotic actions of pirfenidone. Data elaborating on these new findings will be presented at GTCbio's Protein Kinases in Drug Discovery and Development conference taking place in Boston on May 8-9, 2006.
Prior in vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Data presented from four Phase II clinical trials in over 250 patients suggest that pirfenidone may impact 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. In 2004, the U.S. Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA) granted pirfenidone orphan drug designation for the treatment of IPF. InterMune has worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases.
IPF is a disabling and ultimately fatal disease that affects approximately 83,000 people in the United States, with approximately 30,000 new cases developing each year. InterMune believes a similar number of people in Europe have the disease. Those diagnosed with IPF are usually between the ages of 40 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. The disease is very deadly, with a median survival time from diagnosis of two to five years, and a five-year survival rate of approximately 20%. There are currently no drugs approved by the FDA or EMEA 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 pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology pipeline includes the two most clinically advanced development programs in the field of IPF: ActimmuneŽ (interferon gamma-1b) is being evaluated in the Phase III INSPIRE trial, and pirfenidone is being evaluated in the Phase III CAPACITY program. The hepatology portfolio includes the lead HCV protease inhibitor compound (ITMN-191, formally known as ITMN B), a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D 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 annual report on Form 10-K filed with the SEC on March 13, 2006 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to our intellectual property rights; and (v) 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-K and InterMune's other periodic reports filed with the SEC.
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