Isolagen, Inc. Reorganizes as Fibrocell Science, Inc.
- Names New Board of Directors -
- FDA Advisory Committee to Review Azfibrocel-T Application for Wrinkles this Week -
EXTON, Pa., Oct. 6 /PRNewswire-FirstCall/ -- Isolagen, Inc. has reorganized and emerged from bankruptcy as Fibrocell Science, Inc. (OTC Bulletin Board: FCSC), a biotechnology company focused on developing regenerative fibroblast cells for aesthetic, medical and scientific applications. The Company has named a new Board of Directors. The Food and Drug Administration (FDA) is currently reviewing the biologics license application (BLA) for Fibrocell Science's lead therapy, azfibrocel-T (formerly Isolagen Therapy), in development to treat nasolabial fold wrinkles. Azfibrocel-T is the sole topic for discussion at the Cellular, Tissue and Gene Therapies Advisory Committee Meeting on October 9, 2009 in Bethesda, MD.
Fibrocell Science, Inc. Names New Board of Directors
Fibrocell Science, Inc. has appointed a new Board of Directors and named David Pernock as chairman. Mr. Pernock joins Fibrocell Science with extensive commercial experience, most recently as senior vice president, Pharmaceuticals and Vaccines at GlaxoSmithKline. New Fibrocell Science board members named to date are Paul A. Hopper, managing director of Cappello Group, who has more than 20 years experience in international public company markets -- primarily in the medical, healthcare and biotechnology sectors; Kelvin D. Moore, consultant sales director for Seaborne Group with extensive experience in project leadership, business strategy, finance, business consultancy, new ventures, management and executive development; and Robert S. Langer, Ph.D., professor, chemical & biomedical engineering, Massachusetts Institute of Technology, and distinguished leader in the field of biomedical engineering.
Declan Daly, who was instrumental in the company's reorganization and had served as an executive at Isolagen, will continue to lead Fibrocell Science as interim chief executive officer (CEO). The Board intends to name a CEO in the near future, and at that time, Declan Daly will continue to serve as chief operating officer (COO) and chief financial officer (CFO).
"We welcome our new Board members and value their contributions during this transformational time for the Company," said Declan Daly. "We have a major near-term company milestone this week when the FDA advisory committee will review azfibrocel-T, our lead investigational cell therapy for the treatment of nasolabial fold wrinkles. We look forward to gaining Committee input, and working with the FDA as we seek to bring this novel aesthetic therapy to the market in 2010."
BLA Review Underway; FDA Advisory Committee Scheduled
In May 2009, the FDA accepted for full review the BLA of azfibrocel-T for the treatment of moderate to severe nasolabial fold wrinkles. The Prescription Drug User Fee Act (PDUFA) target date for FDA response is January 4, 2010.
The azfibrocel-T pivotal Phase III safety and efficacy studies (IT-R-005; IT-R-006) evaluated a total of 421 individuals at 13 clinical sites across the United States. Study results demonstrated a significant difference in therapy results compared to placebo (p < 0.01). No serious adverse events were reported.
The Cellular, Tissue and Gene Therapies Advisory Committee Meeting will be held on October 9, 2009 in Bethesda, Maryland. Background materials for the meeting are expected to be made available by the FDA on www.fda.gov no later than two business days before the meeting.
Azfibrocel-T, proposed brand name Laviv(TM), is an investigational autologous cell therapy. In the Fibrocell Science patented process, a patient's own natural fibroblasts are extracted, multiplied and re-injected as personalized therapy. Fibroblasts are cells which contribute to the formation of connective tissue fibers. The therapy is currently under review by the FDA for the treatment of nasolabial fold wrinkles. Fibrocell Science, Inc. is planning to continue studies for additional aesthetic and therapeutic indications for azfibrocel-T.
About Fibrocell Science, Inc.
Fibrocell Science, Inc., (OTC Bulletin Board: FCSC) is a biotechnology company focused on developing regenerative fibroblast cells for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com.