SAN FRANCISCO, Nov. 14 /PRNewswire-FirstCall/ -- InterMune, Inc. announced today the presentation of clinical data from three separate investigator studies evaluating the use of daily Infergen(R) (interferon alfacon-1, or consensus interferon) in combination with ribavirin for the treatment of patients infected with hepatitis C virus (HCV) who failed to adequately respond to first line therapy of pegylated interferon plus ribavirin (PEG nonresponders). The findings were presented at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) being held in San Francisco this week. Several additional studies from InterMune scientists, collaborators, and independent investigators that evaluated InterMune products in various HCV patient settings were also presented at the conference.
"Infergen(R) is currently approved for the treatment of chronic HCV infection in patients when administered three times weekly. These three single-center investigator trials provide further support for the rationale and design of our Phase III DIRECT trial that investigates the use of daily dosing of Infergen(R) plus ribavirin in PEG nonresponders," stated Dan Welch, President and CEO of InterMune.
Consensus Interferon and Ribavirin in Patients with Chronic Hepatitis C who were Non-responders to Prior Therapy with either Interferon Alfa and Ribavirin or PEG-Interferon and Ribavirin
Kevin Chen, M.D. of Loyola University Medical Center in Maywood, Illinois presented a retrospective analysis showing an effect of daily Infergen(R) in achieving a sustained viral response in nonresponders. HCV patients who had previously failed interferon therapy were treated daily for 48 weeks with 15 micrograms of Infergen(R) plus ribavirin. Doses were adjusted as necessary for hematological side effects and patients were allowed to use growth factors with their treatments as needed. At the conclusion of treatment, 72% (55/76) of HCV patients studied were HCV RNA negative. At 24 weeks after treatment was stopped, 50% (38/76) remained HCV RNA negative, indicating a sustained viral response in these patients. One patient on treatment underwent liver transplantation and stopped treatment. The authors concluded that these data suggest that daily Infergen(R) plus ribavirin may represent a potential alternative treatment for PEG-nonresponders.
High Dose Consensus Interferon and Ribavirin Therapy is an Effective Treatment of Chronic Hepatitis C Infection in Patients who are Resistant to PEG-Interferon and Ribavirin -- Preliminary SVR Data
Kenneth Rothstein, M.D. of Albert Einstein Medical Center in Philadelphia, Pennsylvania presented a study evaluating the safety and efficacy of high-dose daily Infergen(R) plus ribavirin in the treatment of 32 HCV patients who had previously failed pegylated interferon plus ribavirin therapy, including both non-responders (70%) and relapsers. Patients were treated with 27 micrograms of daily Infergen(R) plus ribavirin for the first four weeks, 18 micrograms of daily Infergen(R) plus ribavirin for the next eight weeks, and 15 micrograms of daily Infergen(R) plus ribavirin for the successive 36 weeks. At 12 weeks, 62.5% of patients (20/32) showed an early viral response. Of the twelve patients who completed 72 weeks of treatment, 25% (3/12) achieved a sustained viral response. Six patients were dose reduced, and three patients stopped therapy due to adverse side effects. This study included patients with advanced liver disease, lowering the overall expected sustained viral response. The authors concluded that for patients with advanced histological disease who had previously failed therapy with a pegylated interferon plus ribavirin, the combination of high dose Infergen(R) plus ribavirin is a well-tolerated and effective option.
Early Viral Response to Consensus Interferon plus Ribavirin Therapy in Patients who are Non-responders or Relapsers to Prior PEG-Interferon plus Ribavirin Therapy
Reem Ghalib, M.D. of the Liver Institute at Methodist Dallas Medical Center in Dallas, Texas presented interim data of response to daily Infergen(R) plus ribavirin therapy in 45 HCV patients who had previously failed standard pegylated interferon plus ribavirin therapy (27 non-responders, 18 relapsers). Twelve weeks of treatment of these patients with 15 micrograms of daily Infergen(R) plus ribavirin resulted in an early viral response (a greater than or equal to 2 log decline in HCV RNA, as measured by PCR) in 77% of non-responders (17/22) and 100% of relapsers (13/13). Discontinuations for adverse events occurred in 7% of non-responders (2/27) and 6% of relapsers (1/18). The authors concluded that this early data suggests that daily 15 microgram dosing of Infergen(R) in combination with ribavirin may be a viable treatment option for pegylated interferon plus ribavirin non-responders and relapsers, and encouraged further study.
About Chronic Hepatitis C
According to the Centers for Disease Control and Prevention, an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected. HCV causes an estimated 10,000 to 12,000 deaths annually in the United States and is the leading indication for liver transplant. The prevalence of chronic HCV is increasing. First-line treatment for patients chronically infected with HCV is a pegylated interferon alpha-2 plus ribavirin. Approximately half of all patients treated do not respond. There are approximately 200,000 PEG-non-responders in the United States and the number is growing by an estimated 50,000 each year.
About Infergen(R) (interferon alfacon-1)
Infergen(R) is a bio-optimized type 1 interferon alpha indicated for treatment of adult patients with chronic HCV infections with compensated liver disease and is approved for three times-per-week dosing. Infergen(R) is the only interferon alpha with data in its label regarding use in patients following relapse or non-response to certain previous treatments. The most common side effects are flu-like symptoms (i.e., headache, fatigue, fever, myalgia, and rigors). Physicians and patients can obtain additional prescribing information regarding Infergen(R), including the product's label, safety profile and the black box warning for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and infectious disorders, by visiting www.infergen.com.
About InterMune
InterMune is a biopharmaceutical company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a broad and deep late-stage product portfolio addressing Idiopathic Pulmonary Fibrosis (IPF) and HCV infections, particularly non-responders, or those patients who do not respond to first- line therapy. The pulmonology portfolio includes Actimmune(R) and pirfenidone. Actimmune(R) is being evaluated in the INSPIRE Trial, a Phase III study in patients with IPF. Pirfenidone is also being developed for the treatment of IPF. In addition to three-times-a-week Infergen(R) (interferon alfacon-1), a currently marketed product indicated for the treatment of chronic HCV infections, the hepatology portfolio includes the DIRECT Trial, a Phase III study of daily Infergen(R) plus ribavirin in non-responders. Additionally, InterMune is developing a pre-clinical stage small molecule program targeted at the HCV protease. For additional information about InterMune and its development 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 quarterly report on Form 10-Q filed with the SEC on November 7, 2005 (the "Form 10-Q") and other periodic reports filed with the SEC, including the following: (i) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (ii) risks related to achieving positive clinical trial results and (iii) 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-Q and InterMune's other periodic reports filed with the SEC.
InterMune, Inc.CONTACT: investors, Judy Hayes of InterMune, Inc., +1-415-466-2242, orir@intermune.com; or media, Pam Lord of Atkins + Associates,+1-858-527-3494, or plord@irpr.com, for InterMune, Inc.
