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Zadaxin
SciClone's Goal...
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.
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