AEGiS-PRn: Principal Investigator Reports Statistically Significant Results in Randomized and Controlled U.S. Hepatitis C Trial Using ZADAXIN(R) Thymosin Alpha 1

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Principal Investigator Reports Statistically Significant Results in Randomized and Controlled U.S. Hepatitis C Trial Using ZADAXIN(R) Thymosin Alpha 1

PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Wednesday, 2 October 1996

SAN MATEO, Calif., Oct. 2 /PRNewswire/ -- SciClone Pharmaceuticals, Inc. (Nasdaq: SCLN) reported today publication of an abstract by the principal investigator of its U.S. randomized, double-blind placebo controlled chronic hepatitis C trial. The abstract reports that the combination of ZADAXIN and alpha interferon demonstrated statistically significant higher efficacy than single agent alpha interferon or placebo at achieving biochemical end-treatment response in patients with chronic active hepatitis C. The abstract is included in the current issue of the journal Hepatology by the principal investigator in the study, Kenneth E. Sherman, M.D., Ph.D., of the University of Cincinnati Medical Center. The treatment phase results of the trial will be presented in detail by Dr. Sherman at the upcoming annual meeting of the American Association for the Study of Liver Diseases ("AASLD"), November 8-12, 1996 in Chicago. In addition to the biochemical data, Dr. Sherman will also present at the upcoming AASLD meeting virologic end-treatment data showing that the combination of ZADAXIN and alpha interferon demonstrated statistically significant higher efficacy than single agent alpha interferon or placebo and histologic end-treatment data showing that the combination of ZADAXIN and alpha interferon demonstrated statistically significant higher efficacy than placebo.

The primary goal of the study, which was conducted at the University of Cincinnati Medical Center, Fitzsimons Army Medical Center and Walter Reed Army Medical Center, was to determine the efficacy of combination treatment with ZADAXIN and alpha interferon for treatment of chronic active hepatitis C. The trial was randomized, double-blind and placebo-controlled and the treatment cycle was six months. Enrolled patients had persistent ALT abnormalities and chronic active hepatitis C on liver biopsy. Biochemical response was prospectively defined in the study protocol as normalization of ALT levels on the last two study visits. Virologic data (RNA viral titers) was evaluated by the branch-chain method. Histologic data (liver biopsy) was evaluated by the Knodell scoring system. A total of 110 patients were enrolled and 103 completed the full course of treatment. Patients were randomized into one of three groups: a) ZADAXIN (1.6 mg twice weekly) plus alpha interferon (three million units three times weekly); b) alpha interferon (three million units three times weekly) alone; and c) placebo.

"The statistically significant results reported by Dr. Sherman in the treatment phase of this trial are extremely positive and encouraging, and are a major move forward in our development efforts of ZADAXIN in the United States as a treatment for chronic hepatitis C," said Donald R. Sellers, President and Chief Executive Officer of SciClone Pharmaceuticals.

He added, "These results continue to validate the fact that ZADAXIN is an effective drug in the treatment of serious viral illnesses. We are eagerly awaiting the presentation of Dr. Sherman's complete report at the upcoming AASLD meeting."

The Center for Disease Control estimates that 3.9 million Americans are infected with the hepatitis C virus, and the American Liver Foundation estimates that an additional 170,000 new cases are reported each year. Hepatitis C can cause chronic liver problems and cirrhosis and is believed to facilitate the progression of liver cancer.

ZADAXIN, SciClone's lead product, is a synthetically produced immunomodulator that stimulates the immune system's disease-fighting properties. In addition to hepatitis C, ZADAXIN is also under investigation as a treatment for hepatitis B and HIV. SciClone has received licenses to market ZADAXIN as a treatment for hepatitis B in China, the Philippines and Singapore. SciClone has pending new drug applications for permission to market ZADAXIN in Hong Kong, India, Indonesia, Malaysia, Mexico and Cyprus. The Company expects to file an additional 12 new drug applications for ZADAXIN in Asia, the Middle East, and Latin America prior to the end of 1996.

The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ materially from the Company's expectations. In addition to the matters described in this release, future actions by the Food and Drug Administration or equivalent regulatory authorities in foreign countries, results of pending or future clinical uses, as well as the risk factors listed from time to time in the Company's SEC reports, including, but not limited to its Annual Report on Form 10-K, may affect the actual results achieved by the Company.

SciClone Pharmaceuticals is an international biopharmaceutical company engaged in the acquisition, development and commercialization of pharmaceuticals worldwide. SciClone's focus is on therapeutics for diseases that are chronic and life-threatening, including hepatitis B and C, immune system disorders and cancer.

NOTE TO EDITORS: SciClone press releases are available at no charge through SciClone's fax information service and on PR Newswire's Web site. For a menu of SciClone press releases or to retrieve a specific release, call 800-996-7256, or http://www.prnewswire.com on the Internet./

CONTACT: Mark Culhane , Chief Financial Officer of SciClone Pharmaceuticals, Inc., 415-358-3456

Keywords: HEPATITIS; IMMUNE SYSTEM; HIV

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