Phase II Study of Interferon Gamma-1b Fails to Meet Primary Endpoint of Reversal of Fibrosis

BRISBANE, Calif., Jan. 21 /PRNewswire-FirstCall/ -- InterMune, Inc. (NASDAQ:ITMN) today announced results of an exploratory Phase II clinical trial evaluating interferon gamma-1b for the potential treatment of advanced liver fibrosis, or cirrhosis, caused by hepatitis C virus (HCV) in patients who have failed standard antiviral therapy. The objectives of the study were to evaluate safety and the ability of interferon gamma-1b treatment to reverse fibrosis in chronic hepatitis C patients with advanced liver disease when administered for 48 weeks. The primary endpoint of the study, reversal of liver fibrosis as determined by the Ishak histology scoring system, was not met. Interferon gamma-1b was generally well tolerated and side effects were consistent with those seen in previous experiences.

"We have learned from this study that interferon gamma-1b is generally well tolerated in this patient population," said James Pennington, M.D., Executive Vice President of Medical and Scientific Affairs at InterMune. "We believe that earlier intervention in milder patients over a longer period of time may be necessary to demonstrate efficacy."

About interferon gamma-1b (Actimmune(R))
Interferon gamma is a naturally occurring protein that stimulates the immune system. InterMune markets Actimmune for the treatment of two life-threatening congenital diseases: chronic granulomatous disease and severe, malignant osteopetrosis. Presently, InterMune is conducting a Phase III study of interferon gamma-1b in idiopathic pulmonary fibrosis (IPF), and a Phase III study of interferon gamma-1b in ovarian cancer. The most commonly observed side effects are flu-like symptoms, including fever, headache and chills. Physicians and patients can obtain additional prescribing information regarding Actimmune, including the product's safety profile, by visiting www.actimmune.com.

Source: InterMune, Inc.