Fibrocell sinks after FDA requests more animal data

Fibrocell Science Inc. (NASDAQ:FCSC) fell $1.54 (24%) to $4.95 after it said FDA requested additional animal safety studies in an IND application for FCX-007. The company said it expected to amend the IND with the new data in 1Q16 and begin a Phase I/II trial in 2Q16. In August, Fibrocell said it planned the start the trial by YE15.

Fibrocell and partner Intrexon Corp. (NYSE:XON) submitted the IND in July for the gene-modified autologous fibroblast that encodes collagen type VII( COL7A1) to treat recessive dystrophic epidermolysis bullosa (RDEB). The study FDA requested is one in which FCX-007 would be injected into severe combined immunodeficiency (SCID) mice; the companies had included a study in the IND in which FCX-007 was injected into human skin grafted onto SCID mice. ...