InterMune Initiates Phase II Trial of ACTIMMUNE(R) in the Treatment Of Cystic Fibrosis
Wednesday February 28, 6:00 am Eastern Time
Press Release
SOURCE: InterMune Pharmaceuticals, Inc.
InterMune Initiates Phase II Trial of ACTIMMUNE(R) in the Treatment Of Cystic Fibrosis
BURLINGAME, Calif., Feb. 28 /PRNewswire/ -- InterMune (Nasdaq: ITMN - news) announced today that it has commenced enrollment in its Phase II clinical trial evaluating the safety and efficacy of inhaled ACTIMMUNE® (Interferon gamma-1b) for the treatment of cystic fibrosis. Cystic fibrosis is a common inherited disorder that typically presents in childhood and leads to chronic pulmonary infections, inflammation, and a shortened life span.
``The initiation of the Phase II trial for ACTIMMUNE® in the treatment of cystic fibrosis is a promising step in the development of new treatments for this debilitating disorder,'' said W. Scott Harkonen, M.D., CEO and President of InterMune. ``There are approximately 23,000 people in the United States with cystic fibrosis representing an annual market opportunity of up to approximately $500 million for ACTIMMUNE®.''
``This is the first use of a biologic response modifier in cystic fibrosis and represents a completely new approach to treatment,'' stated the study's principal investigator, Richard B. Moss, M. D., Professor of Pediatrics and Director of the Stanford Cystic Fibrosis Center. ``We are very pleased and excited to have started this study.''
``With the start of the cystic fibrosis trial, InterMune's clinical program now includes three active Phase II clinical trials with ACTIMMUNE®, including a trial for the treatment of serious fungal infections and a trial for the treatment of atypical mycobacterial infections,'' said James Pennington, M.D., Executive Vice President of Medical and Scientific Affairs for InterMune. ``We also have two active Phase III clinical trials with ACTIMMUNE®, including a trial for idiopathic pulmonary fibrosis (IPF) and one for multidrug-resistant tuberculosis (MDR TB). A Phase III trial for ovarian cancer is planned for the second half of this year.''
Cystic fibrosis is a disease characterized primarily by thick mucus, chronic bacterial infection and progressive airway disease leading to a serious decline in lung function. Approximately ninety percent of patients die of respiratory failure due to chronic pulmonary infections accompanied by an exaggerated inflammatory response in the airways. There is no cure for cystic fibrosis and the standard treatments, including antibiotics and mucus thinning therapies, are less than optimal. InterMune believes that due to the ability of ACTIMMUNE® to regulate the immune system, ACTIMMUNE® may modify the processes that lead to the exaggerated inflammation and thereby reduce the chronic inflammation in the lungs that leads to respiratory failure.
InterMune is a biotechnology company dedicated to the development and commercialization of innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune currently markets ACTIMMUNE® (Interferon gamma-1b) Injection in the United States for the treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis and is in Phase III clinical trials for the treatment of idiopathic pulmonary fibrosis (IPF) and multidrug-resistant tuberculosis (MDR TB). The company also markets Amphotec®, an FDA-approved lipid-complexed form of amphotericin B for the treatment of invasive aspergillosis, a life-threatening fungal infection. For more information about InterMune and ACTIMMUNE®, please visit InterMune's web sites at www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com.
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