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Italian Researchers Report Strong Results In Hepatitis C Trial Using ZADAXIN(R) Thymosin Alpha 1 73 Percent of Patients Achieved Viral Clearance After One Year of Treatment

Source: PR Newswire

SAN MATEO, Calif., Dec. 19 /PRNewswire/ via Individual Inc.
SciClone Pharmaceuticals, Inc. (Nasdaq-NNM: SCLN), an international biopharmaceutical company, today reported that its lead product, ZADAXIN(R) thymosin alpha 1, achieved strong results in a hepatitis C trial led by Dr. Guido Rasi of the Institute of Experimental Medicine in Rome. A report on the trial appears in the current issue of Gut, the journal of the British Society of Gastroenterology. Fifteen patients with chronic hepatitis C were enrolled in the trial. All patients enrolled had biopsy confirmed chronic hepatitis, raised alanine transaminase (ALT) values equal to or greater than 1.5 times the upper normal limit, positive serum hepatitis C virus ("HCV RNA") by polymerase chain reaction ("PCR") testing, and compensated liver disease. Thirteen patients had HCV RNA genotype 1b which in published reports on the treatment of hepatitis C is often associated with cirrhosis, liver cancer and a poor response to treatment with single agent alpha interferon, currently the only FDA approved therapy for chronic hepatitis C. The patients in Rasi's trial received a combination of lymphoblastoid alpha interferon and thymosin alpha 1 therapy for one year and were followed for an additional six months. The treatment protocol included a "loading dose" of thymosin alpha 1 (1.0 mg subcutaneously) for four consecutive days, followed on the fourth day by the first interferon injection (three million units). For the next 51 weeks, the patients received 1.0 mg of thymosin alpha 1 twice weekly, and three million units of interferon three times per week. A response to treatment was defined at 12 months as a negative serum HCV RNA by PCR. A sustained response was defined as a negative serum HCV RNA by PCR six months after completion of treatment. After six months of treatment, 47 percent of the patients were found to be HCV RNA negative. After one year of treatment, 73 percent of the patients were HCV RNA negative. After the six month follow-up period, 40 percent of the patients showed a sustained response to treatment and continued to be HCV RNA negative. Among the HCV genotype 1b patients, 69 percent were HCV RNA negative after one year of treatment with 39 percent exhibiting sustained response after the six-month follow-up. "These trial results, both the response to treatment and sustained response rates, are very exciting, particularly the difficult to treat genotype 1b response rates," said Donald R. Sellers, President and Chief Executive Officer of SciClone Pharmaceuticals. "These results support our belief that thymosin alpha 1 has significant potential as a treatment for chronic hepatitis C." ZADAXIN, SciClone's lead product, is a synthetically produced peptide that the Company believes stimulates the immune system's disease-fighting properties. ZADAXIN clinical trials continue to support the safety and efficacy of the treatment. In addition to being investigated as a possible treatment for hepatitis C, ZADAXIN is being investigated as a potential treatment for HIV and has been cleared for marketing in several countries as a treatment for hepatitis B.

The statements made in this press release contain certain forward-looking statements, including conclusions regarding the results of clinical studies and the potential of thymosin alpha 1, that involve a number of risks and uncertainties. Actual events or results may differ 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 trials, 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. SOURCE SciClone Pharmaceuticals Inc. /CONTACT: Mark Culhane, Chief Financial Officer of SciClone Pharmaceuticals, Inc., 415-358-3456/ (SCLN) CO: SciClone Pharmaceuticals Inc. ST: California IN: MTC SU: PDT CW-KL -- LATH025 -- 9219 12/19/96 09:00 EST http://www.prnewswire.com [12-19-96 at 12:00 EST, PR Newswire]

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