Fibrocell Wins $1.4 Million from FDA to Advance FCX-007 In Trials for RDEB

Sep 29, 2018 | FDA, Orphan Drug

Fibrocell received $1.4 million from the U.S. Food and Drug Administration’s Office of Orphan Products Development (OOPD) to support the company’s ongoing clinical trials testing its FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB).

In collaboration with Precigen (a wholly owned subsidiary of Intrexon), Fibrocell developed the experimental gene therapy FCX-007 to correct the cause of RDEB — a defect in the gene Col7 that leads to the production of a faulty type VII collagen protein. Collagen is a protein that binds skin layers, and a defective type VII collagen protein results in frequent blistering and fragile skin.

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