ZADAXIN® (thymosin alpha 1) -
http://www.scicloneinternational.com/zadaxin.shtmlEffective New Treatment for a Major Worldwide Disease
Z A D A X I N™ thymosin alpha 1 (thymalfasin), is a safe and effective treatment for chronic hepatitis B when used alone or in combination with interferon. Primary research indicates that ZADAXIN may be useful in treating a number of other diseases as well, including hepatitis C, non-small cell lung cancer, melanoma, and HIV/AIDS. In addition, ZADAXIN is also indicated as a vaccine adjuvant, to enhance the effectiveness of influenza and hepatitis B vaccines. Viral hepatitis B and C, diseases that afflict more than 500 million people worldwide, may lead to the development of liver cancer and cirrhosis.
ZADAXIN is the synthetic version of thymosin alpha 1, a substance found naturally in the circulation and produced in the body's thymus gland. ZADAXIN stimulates the immune system by affecting T cells and NK cells, which are the body's most potent defense against infectious diseases. It is this ability to act as an immunomodulator that makes ZADAXIN a promising therapy for such a wide variety of clinical conditions.
Safety
Thymosin alpha 1 has an excellent safety record. In clinical and non-clinical studies to date, more than 3,000 patients, including adults, the elderly, and children, with viral hepatitis B and hepatitis C, primary immunodeficiency diseases, and numerous cancers have been treated with thymosin alpha 1 with virtually no drug-related side effects. Nor has there been any worsening of side effects when thymosin alpha 1 is combined with other agents such as interferon and chemotherapy. In animal studies, thymosin alpha 1 has been administered in doses as high as 800 times the recommended human dose with no evidence of adverse clinical signs.
ZADAXIN builds up the immune system by
• Stimulating differentiation of stem cells— the cells that can produce virus fighters in the immune system.
• Increasing the number of virus-fighting T cells—including CD4, CD8, and natural killer cells—that come from stem cells.
• Slowing down the breakdown and removal (apoptosis) of T cells, which are the cells primarily responsible for the cellular immune response.
• Increasing the number of helper cells (Th1 cells) that fight chronic viral infection.
• Increasing the production of proteins (called cytokines) that help in the action and creation of more T cells in the immune response process. The particular proteins are interleukin-2 (IL-2) and interferon gamma (IFN-γ).
• Decreasing the production of the cytokines interleukin-4 (IL-4) and interleukin-10 (IL-10), which are counterproductive in the fight against chronic viral infections.
ZADAXIN directly targets virally infected or cancer cells by
• Increasing the number of surface-marker proteins (MHC Class 1) that are responsible for identification and rejection of foreign agents, like viruses, from the body.
• Slowing down the replication of viruses.
• Decreasing oxidative stress, which dramatically decreases viral replication.
ZADAXIN: Mechanism of Action
