SCICLONE'S ZADAXIN(R) THYMOSIN ALPHA 1 IS EFFECTIVE AND SAFE
IN THE TREATMENT OF CHRONIC HEPATITIS B, HEPATOLOGY ARTICLE REPORTS
ZADAXIN RESPONSE RATES INCREASE AFTER THERAPY ENDS
SAN MATEO, Calif., May 29 /
PRNewswire-AsiaNet/--
SciClone Pharmaceuticals (Nasdaq: SCLN), today announced that results from the Company's Taiwan phase 3 trial published in Hepatology (May 1998) demonstrate that ZADAXIN(R) thymosin alpha 1 is effective and safe in the treatment of chronic hepatitis B. Importantly, the ZADAXIN complete virologic response rate (the conversion from both hepatitis B virus positive to negative and hepatitis B e antigen positive to negative) in the study continues to increase even when measured one year after the end of treatment.
The publication on the study's primary site data, written by Professor Yun-Fang Liaw, M.D. and his colleagues of the Chang Gung Memorial Hospital, Taiwan, included 98 Asian patients with chronic hepatitis B. At the start of the study, patients were randomized to receive 1.6 mg of ZADAXIN two times per week for 26 weeks, 52 weeks or no treatment. Patients were followed for a total of 18 months.
The publication highlights that patients receiving ZADAXIN showed:
* Statistically significant increase in conversion from both hepatitis B
virus positive to negative and hepatitis B e antigen positive to
negative.
At the end of the study, 40.6% of patients receiving 1.6 mg of ZADAXIN
twice per week for 26 weeks tested negative for both hepatitis B virus
and hepatitis B e antigen (an immune response to the hepatitis B virus
that can indicate long lasting remission of the disease) compared to
9.4% of patients in the control group, a statistically significant
result (p=.004).
* Statistically significant histological improvement.
Patients responding to ZADAXIN showed statistically significant
improvement in liver histology (inflammation of the liver) (p<.05),
consistent with the ultimate goals of therapy for hepatitis B -- to
prevent progression to serious liver disease, including liver cancer and
cirrhosis.
* Experienced no significant side effects.
Professor Liaw and his co-workers, commenting on this recent Hepatology article, said: "Thymosin alpha 1 is safe and effective in the treatment of chronic hepatitis B. The thymosin alpha 1 response rate is statistically significant in the six month treatment group when compared to control. It also reduces liver inflammation. Thymosin alpha 1 therapy offers renewed hope in the fight against chronic hepatitis B." Hepatitis B is a potentially deadly liver disease and one of the most common causes of death in the world.
According to the World Health Organization, approximately 350 million people, or 5% of the world's population, are chronic carriers of the hepatitis B virus in their blood. These carriers of the hepatitis B virus have a 200-fold increased chance of developing serious liver disease, including liver cancer, the most common cancer in the world, and cirrhosis. Currently, ZADAXIN and interferon (a drug that produces a sustained response in less than one third of Asian patients treated and causes debilitating side effects) are the only established therapies for hepatitis B in certain Asian markets, including the People's Republic of China.
SciClone markets ZADAXIN in the People's Republic of China, the Philippines and Singapore for the treatment of hepatitis B. The drug also has been approved in Peru and Kuwait for treatment of hepatitis B and in Argentina and Italy as an influenza vaccine adjuvant. SciClone's exclusive Japanese partner, Schering-Plough K.K., recently launched a Phase 3 study of ZADAXIN in Japan for hepatitis B. SciClone has 18 ZADAXIN hepatitis B marketing applications pending in Asia, Latin American and the Middle East. SciClone intends to file a ZADAXIN hepatitis B marketing application in Taiwan during the second quarter.
SciClone Pharmaceuticals, Inc. is an international biopharmaceutical company that acquires, develops and commercializes specialist-oriented drugs for treating chronic and life-threatening diseases, including hepatitis B, hepatitis C, cystic fibrosis, cancer and immune system disorders. Press releases and corporate information from SciClone Pharmaceuticals are available on the Internet at www.sciclone.com and by fax at 800-996-7256.
SOURCE SciClone Pharmaceuticals, Inc.
-0- 05/29/98
/CONTACT: Shawn K. Singh, Senior Vice President of SciClone Pharmaceuticals, 650-358-3456/ /Company News On-Call:
http://www.prnewswire.com or fax, 800-758-5804, ext. 775865/ /Web site:
http://www.sciclone.com/ (SCLN)
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