Tuesday January 8, 7:01 am Eastern Time
Press Release
SOURCE: InterMune, Inc.
InterMune Announces Start of Phase II Trial of Actimmune for the Treatment Of Liver Fibrosis
Actimmune May Become First Anti-fibrotic Therapy for Advanced Liver Disease
BRISBANE, Calif., Jan. 8 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - news) announced today that it has begun enrolling patients in its Phase II clinical trial of Actimmune® (Interferon gamma-1b) injection for the treatment of severe liver fibrosis, or cirrhosis, caused by hepatitis C virus (HCV). The objective of the study, called AEGIS (Anti-fibrotic Efficacy Gamma Interferon Study), is to evaluate the safety and anti-fibrotic activity of Actimmune in HCV patients who have failed standard antiviral therapy.
More than four million people are affected with HCV in the United States, and current antiviral therapy for HCV infection is effective in only approximately 50% of patients. Because treatment is often not effective, continued HCV infection leads to progressive liver fibrosis or cirrhosis (scarring caused by the accumulation of tough fibrous proteins). These patients are at an increased risk of developing life-threatening complications such as internal bleeding, inability to remove toxins from the blood, progressive liver failure and death.
``Interferon gamma has been shown to inhibit activation, proliferation and production of extra-cellular proteins associated with fibrosis in the hepatic stellate cells -- the key cell type involved in liver fibrosis,'' said Henry Hsu, MD, Vice President of Clinical Research at InterMune. ``Preclinical and clinical data have demonstrated that Interferon gamma may prevent or reverse the development of cirrhosis. Based on these data, we believe the results of this trial, which we expect in early 2004, could represent a major advance in the management of patients with advanced liver disease.''
In the Phase II, multi-center, placebo-controlled study, 450 patients will be randomized to receive either placebo, 100 mcg of Actimmune or 200 mcg of Actimmune three times per week via subcutaneous injection. The study is designed to evaluate the proportion of patients showing a reduction of one or more points on the fibrosis staging score (using the Ishak staging system, a standard clinical measurement in this disease) following treatment with Actimmune, compared to placebo, for 48 weeks.
``There is a clear unmet medical need in patients suffering from HCV-related liver fibrosis, as they have few, if any, effective treatment options,'' said W. Scott Harkonen, M.D., President and Chief Executive Officer of InterMune. ``Actimmune is a promising therapy against this disease, and if demonstrated safe and effective in this study, could also possibly be used broadly to treat other forms of liver cirrhosis such as those caused by alcoholism, metabolic disorders or the hepatitis B virus.''
About Actimmune in Liver Fibrosis
Actimmune is being investigated as a potential treatment for liver fibrosis based on an emerging body of evidence that demonstrates the importance of interferon gamma as a cytokine that modulates the interaction of a downstream protein, transforming growth factor-beta (TGF-beta), that has been shown to play a critical role in the pathogenesis of fibrotic diseases. Data from in vitro studies, studies in animal models of liver fibrosis and studies in humans with HCV infections and idiopathic pulmonary fibrosis (IPF) support a potential therapeutic role for Interferon gamma in the inhibition of fibrosis in the liver and other organs.
About Actimmune
Actimmune is an approved product on the market for the treatment of two rare congenital diseases, chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. InterMune is conducting or planning to conduct multiple Phase II and three Phase III clinical studies with Actimmune, including a Phase III clinical trial for the treatment of IPF. The company plans to announce the results of this trial in November 2002.
InterMune recently reported positive results from a Phase II clinical trial examining the use of Actimmune in combination with amphotericin B for the treatment of cryptococcal meningitis, a difficult-to-treat and life-threatening fungal infection. The company plans to initiate a Phase III trial of Actimmune for the treatment of ovarian cancer. Studies are also ongoing with Actimmune for the treatment of cystic fibrosis and atypical mycobacterial infections.
About InterMune
InterMune is a commercial-stage biotechnology company dedicated to developing innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune has three marketed products, growing product revenues and advanced-stage clinical programs addressing a range of diseases with attractive commercial markets. For additional information about InterMune, please visit www.intermune.com. |
