Actimmune May Become First Anti-fibrotic Therapy f

liver411

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 visitwww.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 statements indicating that: Interferon gamma may prevent or reverse the development of cirrhosis and represent a major advance in the management of patients with advanced liver disease; Actimmune could possibly be used more broadly to treat other forms of liver cirrhosis; Interferon gamma may have a potential therapeutic role in inhibiting fibrosis in the liver and other organs; InterMune expects to complete the liver fibrosis study early in 2004; InterMune is 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 and a Phase III trial for the treatment of ovarian cancer; and initial results from the IPF trial are expected in November 2002. 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'' and the other risks and factors discussed in InterMune's 8-K report filed with the SEC on December 21, 2001, and other periodic reports (i.e., 10-K, 10-KA, 10-Q and 8-K) filed with the SEC, which are incorporated herein by reference. The risks and other factors that follow, concerning the forward-looking statements in this press release, should be considered only in connection with the fully discussed risks and other factors discussed in detail in the 8-K report and InterMune's other periodic reports filed with the SEC. InterMune's forward-looking statements in this press release concerning Actimmune are subject to the uncertainties and risks associated with the uncertain, lengthy and expensive drug research and development and regulatory process; budget constraints; third-party manufacturers; significant competition; and InterMune's ability to obtain, maintain and enforce patents and other intellectual property. SOURCE: InterMune, Inc.

medline

WHAT I get mainly from the paper.



Actimmune:



Interferon gamma-1b



mainly for HCV