Isolagen, Inc. Reorganizes as Fibrocell Science, Inc.
October 06 2009 - 9:00AM
PR Newswire (US)
- 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 http://www.fda.gov/ no later than two business days before
the meeting. About Azfibrocel-T 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:FCSC) (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 http://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. DATASOURCE: Fibrocell Science, Inc.
CONTACT: Mike Beyer of Sam Brown Inc., +1-773-463-4211, Web Site:
http://www.fibrocellscience.com/
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