translation agency

PR Newswire
SciClone Begins ZADAXIN(R) U.S Phase 3 Hepatitis C Clinical Trials: First Patients Enrolled and Receiving Treatment

April 15, 2002
SAN MATEO, Calif., April 15 /PRNewswire-FirstCall/ -- SciClone Pharmaceuticals (Nasdaq: SCLN) today announced the first patients in its ZADAXIN U.S. phase 3 hepatitis C clinical trials have been enrolled and are receiving treatment.

"The injection of the first patients in our U.S. phase 3 clinical trials represents the end of years of preparation and the beginning of a new era at SciClone," said Donald R. Sellers, SciClone's President and CEO. "Everyone at SciClone is proud of this accomplishment. Our ZADAXIN U.S. phase 3 trials are designed to demonstrate ZADAXIN contributing a safe, clinically significant benefit in the treatment of hepatitis C. Even more than our international successes, these clinical trials provide our shareholders and the medical community with a clear measurement of our company." SciClone plans to complete patient enrollment and have all patients begin treatment before the end of 2002.

SciClone's U.S. phase 3 hepatitis C clinical trials include only patients who have not responded to previous therapy with either interferon or interferon plus ribavirin. The clinical trials consist of two 500-patient studies. The clinical trials are multi-centered with 20 major hepatology medical centers throughout the U.S. participating in each study. ZADAXIN is being administered in combination with Pegasys(R), F. Hoffmann LaRoche's brand of pegylated alpha interferon to half of the patients while the other half receives a placebo plus Pegasys. Pegasys is provided by Roche without cost to SciClone. These studies are randomized, double-blinded, and placebo- controlled. Patients will be treated for 12 months and then followed for a 6-month observation period. The end points of the study are elimination of hepatitis C virus and histological improvement, both measured at the end of observation. The trial design is consistent with the U.S. FDA standard for demonstrating sustained response and is ideal for ZADAXIN's mechanism of action.

The ZADAXIN plus Pegasys combination therapy clinical trials are designed to show a significant sustained response in non-responder patients, the most difficult to treat segment of the hepatitis C patient population. Current therapy of year-long treatment with pegylated alpha interferon and ribavirin is effective in only about 50% of all hepatitis C patients. The effectiveness of current therapy is highly dependent on the strain, or genotype, of the infecting virus and the viral load, or level of virus present in the patient. For genotype 1 patients with a high viral load, which characterizes about half of the 4 million hepatitis C patients in the U.S., current therapy is effective in only about 30% of the cases. Patients that fail to respond to therapy, the non-responders, seldom respond to a second 12-month regimen of treatment. For example, the success rate for re-treating non-responders with a second year of alpha interferon plus ribavirin therapy is only approximately 8 percent. SciClone estimates that there will be 500,000 non-responders to existing current therapy in the U.S. by 2005.

Hepatitis C is one of the most serious viral infections with complications such as cirrhosis, liver failure and liver cancer. Deaths related to hepatitis C virus in the U.S. are expected to triple by 2010, exceeding the estimated deaths caused by HIV (the virus which causes AIDS). There is no vaccine for hepatitis C.

ZADAXIN has been administered without side effects to over 10,000 patients and is approved for sale in 26 countries, principally for the treatment of hepatitis B and hepatitis C, and certain cancers. ZADAXIN, an immune system enhancer (ISE), is a synthetic preparation of a natural peptide, thymosin alpha 1, which among other positive actions, enhances the body's Th1 immune response to serious viral infections and certain cancers.

SciClone develops and commercializes pharmaceutical and biological therapeutic compounds that are acquired or in-licensed at the stage of late pre-clinical or early clinical development. SciClone's strategic goal, based on the broad therapeutic potential of its lead drug ZADAXIN, is to become the preeminent worldwide provider of immune system enhancers as monotherapies and as critical components of combination drug therapies for infectious diseases and cancer. Other drugs in SciClone's pipeline are intended to protect and expand this franchise, and to address the protein-based disorder that causes cystic fibrosis.

Press releases and corporate information from SciClone are available on the Internet at or by calling the company's Investor Relations Department at 800-724-2566. SciClone's Common Stock is listed on The Nasdaq National Market(R) under the symbol SCLN.

The information in this press release contains forward-looking statements including the timing of completion of patient enrollment and commencement of treatment for our U.S. phase 3 hepatitis C clinical trials. Words such as "expects," "plans," "believe," "may," "will," "anticipated," "intended" and variations of these words or similar expressions are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including our ability to enroll a sufficient number of eligible patients to yield statistically significant results, the speed with which patients are enrolled in the hepatitis C clinical trials and maintenance of the sufficiency and eligibility of the enrolled patient population, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2001 and quarterly report on Form 10-Q for the quarterly period ended September 30, 2001.

SOURCE SciClone Pharmaceuticals Web Site: Company News On Call: Company News On-Call: