Thymalfasin, commercially sold as ZADAXIN®, is a substance which circulates in the blood naturally and elicits a variety of immune system responses targeted against cancer cells and viruses.
SciClone believes that in both immune-mediated cancers (such as melanoma) and viral diseases, thymalfasin works through its demonstrated activation of various arms of the immune system, specifically increasing white blood cell production, including natural killer (NK) cells, cytotoxic lymphocytes (CTLs) and the T-helper 1 (Th1) subset of CD-4 helper cells. At the same time, thymalfasin increases the expression of MHC Class I proteins on the surface of cells which enable the body's immune system to recognize and target the cancer and virally-infected cells more effectively.

Click here for a June 2009 presentation at the IWMG (International Working Melanoma Group) meeting

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In late 2008 SciClone and the U.S. Food and Drug Administration (FDA) reached agreement on the design of a phase 3 registration trial for thymalfasin as a potential treatment for stage IV melanoma. Based on the FDA's review, the agency agrees that the design and planned analysis of SciClone's study adequately addresses the objectives necessary to support a regulatory submission.

About Melanoma

The American Cancer Society estimates in 2008 that approximately 8,420 deaths will occur in the U.S. from melanoma, or skin cancer. Current therapies, including chemotherapeutic agents like dacarbazine (DTIC) and immunotherapeutics such as interferon alpha, are ineffective at extending survival, which is typically only six to nine months for patients with advanced stage IV malignant melanoma.

For Additional Information:
Phase 2 Data from Press Release
Phase 2 Data from ASCO Poster Presentation