FIRST OF TWO PHASE 3 HEPATITIS C TRIALS
SAN MATEO, CA – September 24, 2003 – SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) announced today that it
has completed the planned enrollment of 500 patients in the first of its two phase 3 hepatitis C (HCV) clinical trials evaluating
its lead immune system enhancing drug ZADAXIN. SciClone intends to complete enrollment of the planned 500 patients for
its second phase 3 HCV clinical trial by the end of the first quarter of 2004. SciClone expects all 1,000 patients to have
completed the 12-month course of therapy and six–month follow up observation period by the second half of 2005.
ZADAXIN is the only non-interferon based new drug that we know of currently in phase 3 HCV clinical trials in the U.S.
According to the National Institutes of Health, an estimated 4 million people in the U.S. have been infected with the hepatitis
C virus.
“Reaching our enrollment target is a major milestone and demonstrates our progress with the clinical and regulatory
development of ZADAXIN,” commented Eduardo B. Martins, M.D., Ph.D., Vice President, Medical Affairs of SciClone
Pharmaceuticals. “SciClone’s trials are designed to demonstrate that ZADAXIN, in combination with pegylated interferon
alpha, is effective in treating HCV patients who have not responded to prior therapy with standard of care treatment.”
Current standard therapy for treatment of HCV patients is a 12-month course of pegylated interferon alpha plus ribavirin, a
combination only effective for approximately half of all HCV patients in the U.S. Patients who fail initial therapy are termed
“non-responders.” There is no therapy approved by the U.S. Food and Drug Administration for the re-treatment of these
difficult to treat non-responders. SciClone’s objective is to have ZADAXIN in combination with pegylated interferon alpha
become the first FDA approved therapy for the treatment of non-responders.
About SciClone’s Phase 3 Hepatitis C Trials
SciClone is conducting two 500 patient clinical trials treating hepatitis C patients who have failed to respond to prior
FDA-approved HCV therapies. The two trials are multi-center, randomized and double-blinded studies. The first trial
includes HCV patients without evidence of cirrhosis of the liver and the second trial includes HCV patients with mild cirrhosis
of the liver.
In each of the clinical trials, patients are assigned to a 12-month course of either ZADAXIN and pegylated interferon alpha
or placebo and pegylated interferon alpha. After completing treatment, the patients will be followed for a six-month
observation period. These treatment and follow-up periods are designed to be consistent with the FDA standard for
demonstrating sustained response to HCV therapy. Successful completion of both of these trials would likely be necessary
for FDA approval.
Primary endpoints are a sustained virological response (clearance of HCV from the blood) and an improvement in the liver
histological activity index measured at the end of the six-month observation period.
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