California Stem Cell, Inc. Announces FDA Approval Of Phase 2 Cancer Stem Cell Clinical Trial For Ovarian Cancer
2/18/2014 9:46:19 AM
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 II clinical trial exploring the potential of a patient-specific cancer immunotherapy in women with Stage III or IV ovarian, fallopian tube or primary peritoneal cancer. The randomized, double-blind study is the Company’s second cancer therapy approved for clinical trials by the FDA, bolstering its platform approach to treating late stage solid-tumor cancers. The Company’s patient-specific approach to treating metastatic melanoma, recently approved to begin a Phase III trial, provided sufficient safety data to proceed directly to a Phase II study in ovarian cancer.
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