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California Stem Cell, Inc. Announces FDA Approval Of Phase 3 Cancer Stem Cell Clinical Trial For Metastatic Melanoma


12/3/2013 11:05:27 AM

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IRVINE, Calif.--(BUSINESS WIRE)--California Stem Cell, Inc. (CSC) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s application to begin a Phase III clinical trial exploring the potential of a cancer stem cell-based platform therapy to treat advanced metastatic melanoma. The protocol has received Special Protocol Assessment (SPA), indicating that FDA is in agreement that the design, clinical endpoints, and planned clinical analyses of the Phase III trial address regulatory objectives sufficient for market approval. The therapy has also been granted fast track status by FDA, a designation given to therapies which show promise in treating life-threatening medical conditions, which accelerates the approval of investigational new drugs undergoing clinical trials.

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