Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of...

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 /PRNewswire-FirstCall/ -- 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 <0.0001 and 0.0001, respectively. In Study IT-R-006, statistical
significance was also achieved for both primary efficacy endpoints, achieving
p values of 0.0075 and <0.0001 for the Evaluator and Patient evaluations,
respectively.
Top-line statistical results showed that p values at Month 6 following
third injection were comparable to p values at Month 2, with both observation
periods achieving statistical significance. 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 <0.0001 <0.0001 0.0075

*p values greater than or equal to 0.05 are considered statistically
significant.
Preliminary safety analyses showed the Isolagen Therapy was well tolerated
with safety results comparable to placebo in the clinical studies. No serious
adverse events related to Isolagen Therapy were observed in the studies.
"I am excited by these positive study results suggesting a clinical
benefit from the Isolagen Therapy, a novel therapy using a person's own cells
for the treatment of wrinkles," said Stacy R. Smith, M.D., study investigator
and Assistant Clinical Professor, Division of Dermatology, University of
California San Diego. "I believe the aesthetics community would welcome a new,
first in class, regenerative therapy. The results of these pivotal studies
will generate even greater interest in the outcome of the ongoing Phase II/III
clinical study of Isolagen Therapy for the treatment of acne scars, where
there is a significant unmet need."
The Isolagen Process(TM) is a proprietary cellular processing system that
creates a natural, living cell therapy. By multiplying a person's own
collagen-producing cells, or fibroblasts, into tens of millions of new cells,
a personalized treatment is created that is then returned to the person's
skin. This first of its kind aesthetic treatment, known as the Isolagen
Therapy, is designed to improve skin damage caused by the normal effects of
aging, sun damage, acne and burns.
"We are thrilled with the positive results from our pivotal Phase III
clinical studies of the Isolagen Therapy," said Declan Daly, President and
Chief Executive Officer of Isolagen. "We intend to file our Biologics License
Application (BLA) with the FDA in early 2009 and continue to progress our
ongoing Acne trial. I want to thank the clinical investigators and
congratulate the Isolagen team for their exceptional performance and clinical
achievement in this groundbreaking pivotal study confirming our belief in this
innovative approach to aesthetic skin therapy."
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, 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 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.
SOURCE Isolagen, Inc.

Mike Beyer, Sam Brown Inc., +1-773-463-4211, beyer@sambrown.com