EXTON, Pa. & GERMANTOWN, Md.--(BUSINESS WIRE)--Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell therapy company primarily focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases, and Intrexon Corporation (NYSE:XON), a leader in synthetic biology, today announced plans to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in the first half of 2015 for their drug candidate, GM-HDF-COL7 (genetically-modified human dermal fibroblast, collagen VII). The companies are developing this new cell-based therapeutic for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), the most severe form of the rare connective tissue disorder epidermolysis bullosa. Fibrocell and Intrexon commenced preclinical activities of GM-HDF-COL7 earlier this year and have since attained certain regulatory and development achievements including Orphan Drug Designation in June, a collaborative pre-IND meeting with the FDA in August, and initiation of clinical material manufacturing in September.
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