EXTON, PA, USA I June 08, 2016 I Fibrocell Science, Inc. (FCSC), an autologous cell and gene therapy company focused on developing transformational therapies for diseases affecting the skin, connective tissue and joints, today announced 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 intends to focus its efforts on the development of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa and its earlier stage programs.
“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,” said David Pernock, Chairman and Chief Executive Officer of Fibrocell. “We are grateful for the support of the patients, investigators and staff who participated in the trial.”
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.
About Fibrocell
Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin, connective tissue and joints using genetically-modified autologous fibroblasts. Fibrocell’s most advanced gene-therapy product candidate, FCX-007, is entering a Phase I trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its gene-therapy product candidate for the treatment of linear scleroderma. Both FCX-007 and FCX-013 are being developed in collaboration with Intrexon Corporation (XON), a leader in synthetic biology. In addition, Fibrocell and Intrexon are in collaboration to develop a gene therapy for the treatment of arthritis. For more information, visit www.fibrocell.com or follow us on Twitter at @Fibrocell.
SOURCE: Fibrocell
Post Views: 104
EXTON, PA, USA I June 08, 2016 I Fibrocell Science, Inc. (FCSC), an autologous cell and gene therapy company focused on developing transformational therapies for diseases affecting the skin, connective tissue and joints, today announced 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 intends to focus its efforts on the development of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa and its earlier stage programs.
“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,” said David Pernock, Chairman and Chief Executive Officer of Fibrocell. “We are grateful for the support of the patients, investigators and staff who participated in the trial.”
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.
About Fibrocell
Fibrocell is an autologous cell and gene therapy company translating personalized biologics into medical breakthroughs for diseases affecting the skin, connective tissue and joints using genetically-modified autologous fibroblasts. Fibrocell’s most advanced gene-therapy product candidate, FCX-007, is entering a Phase I trial for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its gene-therapy product candidate for the treatment of linear scleroderma. Both FCX-007 and FCX-013 are being developed in collaboration with Intrexon Corporation (XON), a leader in synthetic biology. In addition, Fibrocell and Intrexon are in collaboration to develop a gene therapy for the treatment of arthritis. For more information, visit www.fibrocell.com or follow us on Twitter at @Fibrocell.
SOURCE: Fibrocell
Post Views: 104
