ZADAXIN®(thymosin alpha 1) Supporting Healthy Immune Function in the Fight Against Viruses & Cancer

ZADAXIN has not been approved for sale in the United States or Europe

OVERVIEW


ZADAXIN (thymalfasin) 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 to better fight infectious diseases and cancers. It is this ability to act as an immunomodulator that makes ZADAXIN a promising therapy for such a wide variety of clinical conditions.ZADAXIN is approved in over 30 countries worldwide (shown in table below) for several different clinical indications, and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV) and certain cancers, and as a vaccine adjuvant, according to the approvals we have in these countries.ZADAXIN has a good safety record. Based on post-marketing treatment experience of more than 300,000 patients, ZADAXIN has been well tolerated and has not been associated with any significant side effects. ZADAXIN has been administered without adverse incident to elderly subjects (up to 101 years old), children (as young as 13 months), and immunocompromised patients. Thus, while ZADAXIN is one of only a few immunomodulators that have been approved for human use, it does not appear to induce any of the side effects and toxicities commonly associated with agents in this class such as interferon and interleukin-2. Additionally, no significant worsening of side effects has been noted when ZADAXIN is combined with other agents such as interferon and chemotherapy. In animal studies, ZADAXIN has been administered in doses as high as 800 times the recommended human dose with no evidence of adverse clinical signs.

ZADAXIN Product Monograph (please click to view file)

Zadaxin Utility in Cancer, click to open ZADAXIN Utility in Cancer Treatment (please click to view file)

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Investigation of the mechanism of action of ZADAXIN at the cellular level has implicated a number of intracellular cell-signaling pathways leading to stimulation of the immune system. These immunological effects can explain ZADAXIN’s effectiveness in enhancement of vaccines, as well as other indications where a stimulated or enhanced immune response is important for an improved host-response, including cancer and viral infections.

ZADAXIN®  Mechanism of Action

ZADAXIN Mechanism of Action

Table: ZADAXIN approvals by indication

Location Indication Status
Argentina, Azerbaijan, Bahrain, Brunei, Cambodia, China, Dominican Republic, Hong Kong, India, Indonesia, Kuwait, Kazakhstan, Kyrgyzstan, Laos, Malaysia, Maldives, Malta, Mexico, Moldova, Pakistan, Peru, Philippines, Russia, Singapore, Sri Lanka, Thailand, Ukraine, United Arab Emirates, Uzbekistan, Venezuela, Vietnam
Chronic Hepatitis B
Marketing Approval
Argentina, Dominican Republic, Mexico, Peru, Philippines, Russia, Singapore, Sri Lanka, Thailand, Ukraine
Chronic Hepatitis C
Marketing Approval
Philippines, Sri Lanka, Thailand
Cancer Adjuvant
Marketing Approval
Argentina, China, Dominican Republic, Hong Kong, Italy, Mexico, Philippines, South Korea, Thailand
Vaccine Enhancer
Marketing Approval
Brazil, Georgia, Myanmar, Peru
Immunostimulant
Marketing Approval
Europe
Malignant Melanoma
Completed Phase 2
Europe
Chronic Hepatitis C
Completed Phase 3
United States
Liver Cancer
Completed Phase 2