Fibrocell Announces FDA Allowance to Initiate Pediatric Enrollment in Phase 1/2 Clinical Trial

Fibrocell Science (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue, today announced that it obtained allowance from the U.S. Food and Drug Administration to initiate enrollment of pediatric patients in the Phase 2 portion of the Company’s Phase 1/2 clinical trial of FCX-007, its gene therapy candidate being developed in collaboration with Intrexon Corporation (NYSE:XON), for the treatment of recessive dystrophic epidermolysis bullosa—a devastating, genetic skin disease with high mortality.

As quoted in the press release:

“Pediatric RDEB patients are among the most vulnerable to this devastating blistering skin disease because of the scarring that develops in childhood and progresses into adulthood,” said Alfred Lane, MD, Chief Medical Advisor of Fibrocell and Professor of Dermatology and Pediatrics (Emeritus) at the Stanford University School of Medicine.  “I am pleased that we now have the opportunity to evaluate FCX-007 in children with the goal of improving wound outcomes for these patients.”

Click here to read the full press release.