Fibrocell Science completes Type C meeting with FDA on FCX-007 trial design
Fibrocell Science announced completion of a Type C meeting with the 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, or 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by the current data in Fibrocell's ongoing Phase 1/2 clinical trial of FCX-007 and the recent publication of draft guidance from the FDA in the areas of gene therapy and epidermolysis bullosa.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, manufacturing and control, or CMC, requirements for the proposed Phase 3 clinical trial and a potential future biologics license application, or BLA, for FCX-007. Based on the feedback from the meeting, Fibrocell plans to submit the protocol in the Q4 and will provide details on the clinical trial design once it is finalized.