FSCO News Isolagen: New drug application, new name
by John George Staff Writer Tuesday, October 6, 2009, 12:11pm EDT
A Food and Drug Administration advisory committee will review a new drug application for a wrinkle treatment being developed by FibroCell Science Inc., formerly Isolagen, on Friday.
Isolagen emerged from bankruptcy court protection with its new name and a new board of directors last month. FibroCell (OTCBB:FCSC) is searching for a new CEO.
To further distance itself from its past financial troubles, the Exton-based company has changed the in-house name of its lead product — formerly known as Isolagen Therapy — to azfibrocel-T.
Azfibrocel-T will be the sole topic for discussion at the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Meeting Friday in Bethesda, Md.
Azfibrocel-T, the proposed brand name for which is Laviv, is a cellular therapy treatment that involves harvesting and multiplying a patient’s own collagen-producing cells, or fibroblasts, into tens of millions of new cells that are returned to a patient’s skin — through injections — to repair the damage that caused wrinkles.
Fibrocell’s new board of directors is led by David Pernock, a GlaxoSmithKline senior vice president who is serving as the board’s chairman. Other members are Paul A. Hopper, managing director of Cappello Group; Kelvin D. Moore, consultant sales director for Seaborne Group; and Robert S. Langer, a professor of chemical and biomedical engineering at the Massachusetts Institute of Technology.
Declan Daly, the CEO at Isolagen, is leading FibroCell as interim CEO. The board intends to name a CEO in the near future. At that time, Daly will continue to serve as the company’s chief operating officer and chief financial officer.
Companies: FibroCell Science Inc., Isolagen
