SciClone’s lead product, ZADAXIN thymosin alpha 1, is a 28 amino acid peptide. Originally isolated from the thymus gland, the drug is now produced through chemical synthesis. The effects of thymosin alpha 1 on the immune system have been studied extensively and are currently undergoing clinical evaluation in the treatment of chronic Hepatitis C and various other life- threatening diseases.
In various in vitro assays, ZADAXIN has been shown to stimulate the human immune system. It promotes the maturation of T-cells, which are involved in the control of various immune responses. As an immunomodulator, ZADAXIN represents a new class of therapy. Data suggest that ZADAXIN may be useful in a number of clinical conditions where alterations of the immune system may play a role in disease progression, such as Hepatitis C, non-small cell lung cancer and melanoma, and HIV/AIDS. ZADAXIN has been shown to be an extremely safe and well tolerated agent. There has been no evidence of toxicity and virtually no reports of drug-related side effects in over 2,000 patients studied to date.
SciClone recently completed its Hepatitis B clinical program with the completion of a Phase III clinical trial with ZADAXIN for chronic Hepatitis B in Taiwan. In the U.S. we are sponsoring a Phase III trial with ZADAXIN in combination therapy with alpha interferon to treat chronic Hepatitis C. In Japan, our licensee, Schering-Plough K.K., recently completed a Phase II clinical trial of ZADAXIN for chronic Hepatitis B. The drug is commercially approved in Singapore, the Philippines, and the People Õf Republic of China and registration has been filed for ZADAXIN in Hong Kong, India, Indonesia, and several other countries. In addition, SciClone anticipates filing approximately twelve additional ZADAXIN new drug applications for the treatment of chronic Hepatitis B in targeted markets prior to the end of 1996.