Fibrocell: Phase 2 Azficel-T Vocal Cord Scarring Trial Fails To Meet Targets

(RTTNews) - Fibrocell Science, Inc. (FCSC), an autologous cell and gene therapy company focused on diseases affecting the skin, connective tissue and joints, announced Wednesday that the primary endpoints were not met in the Company's Phase II clinical trial of azficel-T for the treatment of vocal cord scarring resulting in chronic or severe dysphonia.

Fibrocell said it intends to focus its efforts on the development of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa and its earlier stage programs.

Fibrocell's Phase II study was a double-blind, randomized, placebo-controlled trial designed to test the safety and efficacy of azficel-T injections in subjects with chronic dysphonia caused by idiopathic vocal cord scarring or atrophy.

Primary efficacy endpoints were assessed at four months post last treatment on three different scales: Voice Handicap Index, Mucosal Wave Grade and GRBAS (grade, roughness, breathiness, asthenia and strain).

Although azficel-T did not meet these endpoints vs. placebo, no unexpected safety findings were reported and the treatment was well tolerated.

David Pernock, Chairman and Chief Executive Officer of Fibrocell, said, "We are disappointed that azficel-T did not demonstrate the anticipated benefits for patients in this Phase II clinical trial. While we will continue to assess the data to gain greater insight into the study's outcome and follow these patients through the final (unblinded) 12-month endpoint, we believe this trial was well conducted and addressed the objectives it was designed to evaluate."