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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.





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Blake Masterson

Freelance Writer, Journalist and Father of 5

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