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SciClone, together with our European partner Sigma-Tau S.p.A, completed a large phase 2 trial showing thymalfasin met its primary endpoint and increased response and extended survival for patients diagnosed with stage IV malignant melanoma, the most deadly form of skin cancer. Based on these positive results, our Melanoma Advisory Board recommended we request a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), allowing us to set the primary basis for an efficacy claim in a subsequent New Drug Application should the phase 3 melanoma trial be successful. After reporting final data from the nearly completed phase 3 hepatitis C triple therapy trial in the third quarter of 2008, we intend to finalize our plans for a phase 3 malignant melanoma trial for thymalfasin. 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.
Source: SciClone Pharmaceuticals and Sigma-Tau, phase 2 clinical trial results presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO), June 2007. For Additional Information: |
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