Monday November 12, 6:02 am Eastern Time
Press Release
SOURCE: InterMune, Inc.
Intermune Announces Positive Clinical Data Using Infergen(R) For the Treatment of Hepatitis C
- Infergen Combination Therapy May Be More Effective Than Rebetron(TM) -
BRISBANE, Calif., Nov. 12 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN - news) today announced positive interim results from a Phase IV clinical trial comparing the use of Infergen® (interferon alfacon-1) plus ribavirin to the use of interferon alfa-2b plus ribavirin (Rebetron(TM)) for the treatment of chronic hepatitis C infections. Patients treated with Infergen® in combination with ribavirin achieved a sustained virologic response (SVR) of 56% compared with an SVR of 31% in patients treated with Rebetron(TM). Results were presented at the 52nd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Dallas.
``These data suggest that the combination of consensus interferon plus ribavirin is safe and well tolerated and may be more efficacious than Rebetron(TM) therapy,'' said Col. Maria H. Sjogren, M.D., M.P.H., Chief, Department of Clinical Investigation, Walter Reed Army Medical Center in Washington, D.C. and lead investigator of the Phase IV trial. ``We look forward to completion of the study at the end of next year to confirm the potential benefits of this treatment regimen for patients with hepatitis C.''
In the study, 127 patients with the hepatitis C virus (HCV) were randomized to receive Infergen® plus ribavirin (n=63) or interferon alfa-2b plus ribavirin (n=64) for up to 72 weeks. In an intent-to-treat interim analysis of 70 patients who reached week 72 or discontinued early, researchers observed an SVR rate of 56% in the Infergen® plus ribavirin-treated group (19 of 34) compared with 31% in the interferon alfa-2b plus ribavirin group (11 of 35; p=0.032). The rates of discontinuation were similar in both groups. The side effects associated with Infergen® are similar to those seen with interferon alfa-2b.
In addition, among gentotype-1 infected patients (n=50), researchers found a 41% SVR rate in the Infergen® plus ribavirin-treated group (9 of 22) versus an 18% SVR rate in the interferon alfa-2b plus ribavirin group (5 of 28; p=0.07). Genotype-1-infected patients account for over 60% of the HCV patient population.
``There is a great medical need for alternative therapy for the treatment of hepatitis C because approximately 50% of patients currently fail best available therapy,'' said W. Scott Harkonen, M.D., President and CEO of InterMune. ``This study confirms that Infergen® plus ribavirin makes a compelling treatment option for patients, especially those who have failed previous therapies.''
About Infergen® for Hepatitis C
Infergen®, also known as consensus interferon (CIFN), is a bioengineered type I interferon alfa indicated for the treatment of patients with chronic hepatitis C infections. Additional clinical trials are ongoing to evaluate varied dosing regimens and duration of therapy to optimize sustained antiviral response. Physicians and patients can obtain additional information about Infergen by visiting infergen.com .
Hepatitis C is a progressive blood-borne virus that is a primary cause of acute and chronic liver disease in the United States, according to the National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK). It accounts for about 20 percent of acute viral hepatitis and 60 to 70 percent of chronic hepatitis. Almost four million Americans have the antibody to HCV (anti-HCV), indicating ongoing or previous infection with the virus. Hepatitis C causes an estimated 8,000 to 10,000 deaths annually in the United States.
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 . |
