Business News
Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant
2008-08-05 15:10:00
Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant
Investor Conference Call to be held on Wednesday, August 6, 2008 at 8:00
a.m.
EXTON, Pa., Aug. 5 /EMWNews/ -- Isolagen(TM), Inc. (Amex:
ILE) announced today positive top-line efficacy and safety results from two
pivotal, Phase III clinical studies (Studies IT-R-005 and IT-R-006) of the
Isolagen Therapy(TM) for the treatment of nasolabial folds, or wrinkles.
Each study, conducted under an FDA Special Protocol Assessment (SPA), met
all primary endpoints and was highly statistically significant, making this
a major clinical milestone for the Company.
"This is a significant achievement for Isolagen and an important step
towards bringing the first ever autologous cell therapy product to the
market for aesthetic use. As the future evolves and current therapies
continue to show their age, the need for novel skin rejuvenation products
becomes evident. With these statistically significant results, we believe
we are now in an excellent strategic position," said Nicholas L. Teti, Jr.,
Chairman of Isolagen. "These results further support the proof of principle
for autologous cell therapy and open the door for further research in
aesthetics, acne scars, burn scars and other clinical applications."
The pivotal, Phase III placebo-controlled studies investigating the
efficacy and safety of Isolagen Therapy for the treatment of nasolabial
folds, or wrinkles, evaluated a total of 421 people at 13 clinical sites
across the United States. In Study IT-R-005, both the Evaluator and Patient
evaluations met the co-primary endpoints and were statistically significant
achieving p values of Top-line Statistical Results at Observation Visits (p values*):
005 Patient 005 Evaluator 006 Patient 006 Evaluator
Month 2 0.0001 0.0005 0.0003 0.0039
Month 4 0.0006 0.0003 0.0012 0.0002
Month 6 0.0001
About the Studies
The goal of the Phase III multicenter, double-blind, randomized,
placebo- controlled studies was to demonstrate the efficacy of three
treatments of Isolagen Therapy compared with placebo in the treatment of
bilateral nasolabial folds, or wrinkles, six months following the last
study treatment, using the co-primary endpoints of:
-- Subject Wrinkle Satisfaction Assessment: the person's own assessment
of the wrinkles using a 5-point wrinkle satisfaction scale, and an
-- Evaluator Wrinkle Severity Assessment: the evaluator's live
assessment of each of the bilateral nasolabial fold wrinkles at rest using
a 6-point ordinal wrinkle severity scale with a photoguide as a reference
tool.
Isolagen's Phase III studies for wrinkles were conducted under the Food
and Drug Administration's (FDA) Special Protocol Assessment (SPA)
regulations. The SPA process results in an agreement with the FDA that
successful clinical trial results will form the basis of an efficacy claim
for a marketing application. Although significant, the SPA does not
guarantee approval of a BLA.
Further, Isolagen is currently conducting a Phase II/III clinical
program to investigate the Isolagen Therapy for the treatment of moderate
to severe acne scars.
Investor Conference Call
Isolagen will be hosting an investor conference call and webcast on
Wednesday, August 6, 2008 at 8:00 a.m. Eastern Time to discuss the results
of these Phase III studies. To participate in the audio portion and have
the opportunity to pose questions, dial 1-800-901-5259; Passcode 45113071.
An audio webcast also will be available on the Investor Relations section
of Isolagen's website, http://www.isolagen.com.
A replay of the conference call will be available beginning at August
6, 2008 at 10:30 a.m. Eastern Time. To listen to a replay of the conference
call, dial 1-888-286-8010; Passcode 71787160 or listen via Isolagen's
website. The replay will be available for four weeks.
About Isolagen, Inc.
Isolagen(TM), Inc. (Amex: ILE) is an aesthetic and therapeutic company
committed to developing and commercializing scientific advances and
innovative technologies. The company's technology platform includes the
Isolagen Process(TM), a cell processing system for skin and tissue
rejuvenation which is currently in clinical development for a broad range
of aesthetic and therapeutic applications including wrinkles, acne scars,
burns and periodontal disease. Isolagen also commercializes a
scientifically-advanced line of skincare systems through its majority-owned
subsidiary, Agera(R) Laboratories, Inc. For additional information, please
visit http://www.isolagen.com.
Isolagen Forward Looking Statements
All statements in this news 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. Such statements include,
without limitation, the timely filing of our Biologics Licensing
Application (BLA) with the FDA, the timely completion of our acne trial,
and our ability to complete the regulatory process and market our products
and the market's acceptance of any products we bring to market. 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 our 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, 2007,
as updated in "Item 1A. Risk Factors" in the Company's Quarterly Reports on
Form 10-Q. We operate 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. We disclaim any intention to, and undertake 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 Annual Report on Form 10-K for the year ended December 31,
2007, as well as other public filings with the SEC since such date.
Major Newsire & Press Release Distribution with Basic Starting at only $19 and Complete OTCBB / Financial Distribution only $89
Get Unlimited Organic Website Traffic to your Website
TheNFG.com now offers Organic Lead Generation & Traffic Solutions