Fibrocell Receives Guidance from FDA on Phase 3 Clinical Trial Design for FCX-007
FIBROCELL SCIENCE INC COMMON (FCSC)
NASDAQ:AMEX Investor Relations:
fibrocell.com
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Source: GlobeNewswire
Company Plans to Submit Phase 3 Protocol to FDA in Fourth Quarter of 2018 and Commence Trial in First Half of 2019 EXTON, Pa., Oct. 25, 2018 (GLOBE NEWSWIRE) -- Fibrocell Science, Inc. (NASDAQ: FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced completion of a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of a Phase 3 clinical trial protocol of FCX-007, the Company’s gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The meeting was facilitated by the current data in Fibrocell’s ongoing Phase 1/2 clinical trial of FCX-007 and the recent publication of draft guidance from the FDA in the areas of gene therapy and epidermolysis bullosa. The FDA provided guidance on various design aspects of Fibrocell’s proposed Phase 3 clinical trial. In addition, Fibrocell received guidance on Chemistry, Manufactu
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