Isolagen, Inc. Reorganizes as Fibrocell Science, Inc.
Published: Oct 06, 2009
EXTON, Pa., Oct. 6 /PRNewswire-FirstCall/ -- Isolagen, Inc. has reorganized and emerged from bankruptcy as Fibrocell Science, Inc. (OTC Bulletin Board: FCSC - News), 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 - News) 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.
Forward Looking Statements
All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, without limitation, the timeliness of the target date for FDA response of January 4, 2010, the Company's ability to bring azfibrocel-T to market in 2010, and the Company's ability to hire a new chief executive officer in the near future. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company's control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2008, as updated in "Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company's public filings with the SEC.