Fibrocell Science announced that the Food and Drug Administration (FDA) has granted Fast Track designation to FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).

RDEB is a rare, congenital, debilitating genetic skin disorder that presents as severe painful blisters, open wounds, and scarring due to the deficiency of the protein type VII collagen (COL7). It is a progressive disease that often leads to death. There are currently no pharmacologic treatments for RDEB; treatment is limited to symptomatic therapies such as daily bandaging, hydrogel dressings, antibiotics, feeding tubes and surgeries. 

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Fibrocell, in collaboration with Intrexon Corporation, is currently investigating FCX-007 in a Phase 1/2 trial for the treatment of RDEB. It was previously granted Orphan Drug designation for the treatment of Dystrophic Epidermolysis Bullosa (DEB) and Rare Pediatric Disease designation for RDEB.

FCX-007, a genetically-modified autologous fibroblast that encodes the gene for COL7, is being developed as an injectable for direct administration to the affected areas, thus avoiding systemic distribution.

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