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European Phase 3 Trial Initiated for Combination Therapy of Thymosin Alpha 1, Pegylated Interferon Alpha, and Ribavirin
"In our pursuit to provide better therapy options for hepatitis C patients, the initiation of this European phase 3 clinical trial marks another important milestone in the clinical development of ZADAXIN," commented Dr. Alfred Rudolph, Chief Operating Officer of SciClone Pharmaceuticals. "In early 2006, we expect to report data from our U.S. phase 3 clinical trials showing whether ZADAXIN adds a clinical benefit to pegylated interferon, the cornerstone of current hepatitis C therapy, in treating hepatitis C patients who have failed prior therapy. Concurrently, this European triple therapy clinical trial will allow us to evaluate ZADAXIN's potential as part of triple therapy in treating hepatitis C non-responder patients."
Approximately 170 million people worldwide are infected with the hepatitis C virus (HCV) and 75% of HCV carriers in Europe and North America are infected with the difficult to treat genotype 1 strain of the virus. Most genotype 1 patients fail initial therapy of pegylated interferon and ribavirin and become non-responders.
About the Triple Therapy Trial
This multi-center, double-blinded, placebo-controlled trial plans to enroll approximately 550 non-responder patients, all of whom are infected with HCV genotype 1 and have failed prior combination therapy with pegylated interferon alpha and ribavirin. Patients will be randomized to receive either ZADAXIN (1.6 mg, twice a week) or a placebo (twice a week) and all patients will receive peginterferon alfa-2a (180 mcg, once a week) and ribavirin (1,000 to 1,200 mg, daily, according to body weight). After completing 48 weeks of treatment, patients will be monitored for a 24-week observation period. The primary endpoint is sustained virological response (SVR), defined as the absence of HCV RNA measured at week 72, the end of the 24-week observation period. The secondary endpoints are normalization of ALT (an enzyme that when present in increased levels is an indicator of inflammation or damage of the liver) measured at the end of weeks 48 and 72, absence of HCV RNA measured at week 48, and an improvement in the liver biopsy. Prof. Mario Rizzetto, Professor of Gastroenterology at the University of Turin in Italy, is the lead investigator for this clinical trial.
SciClone previously reported data from a small, single-arm triple therapy pilot clinical trial that showed 19% of genotype 1 combination therapy non-responder patients achieved an SVR. This compares favorably to the 9% SVR observed in a separate, unrelated trial treating genotype 1 combination therapy non-responder patients with pegylated interferon and a similar dose of ribavirin but without ZADAXIN.
Source: SciClone Pharmaceuticals