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SOURCE: University of Southern California

Study Results Presented on New Hepatitis C Therapy At Digestive Disease Week Meeting

Data on Peginterferon Alfa-2b Suggests New, Improved Therapy is on the Horizon

SAN DIEGO, May 22 /PRNewswire/ -- The results of a worldwide multi-center clinical trial indicates that patients with hepatitis C, a virus that causes potentially fatal liver disease, may soon have access to a new treatment option. The study results were presented yesterday at the Digestive Disease Week meeting in San Diego.

The study, led by Karen L. Lindsay, MD, Associate Professor of Clinical Medicine, Gastrointestinal and Liver Diseases at the Keck School of Medicine of the University of Southern California, found that peginterferon alfa-2b administered once weekly is twice as effective than standard interferon alfa-2b as monotherapy for treating hepatitis C, and was just as well tolerated. The current ``gold standard'' of treatment for hepatitis C is combination therapy with interferon alfa-2b, administered three times weekly with daily doses of oral ribavirin.

``The results of this study are very promising for hepatitis C patients,'' said Dr. Lindsay. ``Since peginterferon alfa-2b has been shown to be effective alone, we anticipate that it may be even more effective when used in combination with ribavirin. I expect this combination therapy to become the optimal treatment for hepatitis C in the future.'' Combination therapy with peginterferon alfa-2b and ribavirin is currently in Phase III clinical trials.

Pegylation involves the attachment of polyethylene glycol to the interferon molecule. Pegylation results in slower clearance of the interferon molecule, allowing it to remain in the bloodstream longer, therefore providing a more convenient once-weekly dosing schedule for patients.

Hepatitis C, when left untreated, can lead to cirrhosis (scarring of the liver), liver failure and death, as well as primary liver cancer. It is the leading cause of liver transplantation in the United States and patients often remain without specific symptoms for as long as three decades. Hepatitis C is the most common blood borne infection in the United States, and is estimated to infect nearly 4 million Americans. Approximately 10,000 Americans die from chronic liver disease due to hepatitis C annually, and that death rate is expected to triple in the next 10 to 20 years.

Study Details

The aim of the multi-center clinical trial was to establish the safety and effectiveness of peginterferon alfa-2b in comparison to standard interferon alfa-2b. Participants had never been treated for hepatitis C prior to this study.

Patients participating in the study were divided into four groups, receiving either 0.5 ug/kg, 1.0 ug/kg, or 1.5 ug/kg of peginterferon alfa-2b once weekly, or the standard dose of interferon alfa-2b (three million international units three times weekly).

Results showed that patients treated with all doses of peginterferon alfa-2b had significantly lower levels of detectable virus during treatment, at the end of treatment, and after 24 weeks of follow up, than the group who received the standard interferon. Patients in the peginterferon alfa-2b groups achieved sustained virologic responses (no detectable virus in the blood for 24 weeks after discontinuing treatment) of 18%, 25% and 23% respectively, compared to 12% for the standard interferon group. However, combination therapy with standard interferon alfa-2b and ribavirin remains the most effective treatment available, with sustained virologic response rates of about 40%.

``Once approved for marketing, peginterferon alfa-2b will be another important addition to the hepatitis C treatment arsenal,'' said Dr. John McHutchison, Medical Director of Liver Transplantation at the Scripps Clinic and Research Foundation in La Jolla, CA and a participating investigator in the study. ``The once weekly dosing schedule should make treatment more convenient for patients with hepatitis C, and improve patient compliance.''

Founded in 1885, the Keck School of Medicine of the University of Southern California is a major center for basic and clinical biomedical research, especially in the fields of cancer, gene therapy, the neurosciences and transplantation biology. With more than 960 full-time faculty, the Keck School serves more than one million patients each year through 14 affiliated hospitals in Southern California, including USC University Hospital, USC/Norris Comprehensive Cancer Center, Doheny Eye Institute, Childrens Hospital Los Angeles and Los Angeles County+USC Medical Center, one of the largest teaching hospitals in the nation.

    CONTACT:  Maria De Trizio of Ruder Finn, 212-583-2766, for the University

              of Southern California.