�Isolagen(TM), Inc. (Amex:
ILE) announced results from a prospective, subject label, Phase II study
(IT-R-007) of Isolagen Therapy(TM) for the treatment of facial wrinkles and
creases in some 40 subjects. Study subjects received deuce
treatments of Isolagen Therapy in multiple facial regions ("full face")
approximately basketball team weeks aside. The sketch results reported improvement in
the appearance of wrinkles as scored by a high portion both of study
subjects as well as of independent venire evaluators. The study results also
reported improvement in skin quality as scored by a high percentage of both
study subjects and active investigators.
Six months following their final treatment ("the six-month clock time
point"), 83 percent of subjects reported an advance in their
self-assessed musical score of the appearance of their wrinkles. This scale was the
same as the unitary used in the of late completed Isolagen Therapy pivotal
efficacy studies (IT-R-005 and -006). At the six-month time point, the
results from the independent gore evaluation of study photographs also
showed improvement in the appearance of wrinkles, with the independent
panel scoring melioration in over 75 percentage of participants.
"We are very pleased with the outcome of this explorative study," said
Declan Daly, President and Chief Executive Officer of Isolagen. "We are
peculiarly interested in the responses around cutis quality, as this is
the number 1 time we have assessed the Isolagen Therapy for these authoritative
skin characteristics."
Study IT-R-007 Study Results
As seen in all previous studies of Isolagen Therapy, treatment was very
intimately tolerated in Study IT-R-007. No serious adverse events related to the
Isolagen Therapy were observed.
Efficacy results from the trial showed that 83 per centum of study
subjects reported improvement in the appearance of their wrinkles victimization a
matter assessed, five-point response scale that ranged from "very
dissatisfied" to "very satisfied." Improvement was defined as a one point
act on the scale. The subject appraisal scale is the same scale used in
the recently realized IT-R-005 and 006 polar Phase III studies of
Isolagen Therapy.
The survey results as well included assessments from an independent panel
of three aesthetic dermatologists and formative surgeons wHO were non
involved with the treatment of subjects in the study. Results from these
independent evaluations noted advance in the appearance of wrinkles in
more than 75 per centum of report subjects using an evaluator-assessed,
four-point shell developed for this study, ranging from "no improvement" to
"marked improvement." Improvements were assessed using photographs of
subjects taken at baseline and at the six-month metre point.
Study IT-R-007 too included an assessment of skin character of the study
subjects, comparing results from baseline to the final six-month visit.
Using a Skin Quality Assessment Tool developed for this study, 93 percent
of subjects said their skin quality improved. Additionally, more than 95
percent of subjects showed improvements in skin quality based on the
Treating Investigator Assessment. Subjects and treating investigators each
assessed eight peel characteristics normally seen as the nerve ages and
solar hurt increases. Skin quality characteristics assessed at baseline
and the last six-month visit were: mildness, suppleness, smoothness,
firmness, thickness, moistness, evenness in visual aspect and reinvigorated
appearance. While the Skin Quality Assessment tool is not validated,
Isolagen is evaluating this scale for future use.
"As the principal researcher in the Isolagen IT-R-007 trial, I am
affirmative about the study results which indicate improvement in patients'
facial appearance," aforementioned Dr. Girish Munavalli, Assistant Professor of
Dermatology at Johns Hopkins School of Medicine. "The results suggest that
improvements in both skin texture and contour may be achieved following
Isolagen treatment. I believe this result is a unique finding in the
cosmetic injectable treatment market place, utilizing the subject's possess living
cells to provide the basis for advance."
Conducted at five US sites, the primary objectives of Study IT-R-007
were to assess the safety and efficacy of the Isolagen Therapy. In this
open label study, all subjects received the Isolagen Therapy and there was
no placebo control.
The Isolagen Process(TM) is a proprietary cellular processing system
that creates a natural, living cell therapy. By multiplying a person's have
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 cutis. This number 1 of its kind esthetic treatment, known as the
Isolagen Therapy, is designed to meliorate skin price caused by the normal
effects of aging, sun damage, acne and burns.
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 of rules for peel and tissue
rejuvenation which is presently in clinical development for a broad range
of aesthetic and therapeutic applications including wrinkles, acne scars,
burns and periodontal disease. Isolagen too commercializes a
scientifically-advanced dividing line of skin care systems through its majority-owned
subsidiary, Agera(R) Laboratories, Inc. For extra information, please
visit http://www.isolagen.com.
Isolagen Forward Looking Statements
All statements in this news program release that are non based on historical
fact are "innovative statements" inside the substance 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. While management has based whatsoever
forward-looking statements contained herein on its current expectations,
the information on which such expectations were based may change. These
innovative statements swear 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 take issue from such statements. Such risks,
uncertainties, and former factors include, but are not necessarily limited
to, those jell forth under Item 1A "Risk Factors" in the Company's Annual
Report on Form 10-K for the year complete December 31, 2007, as updated in
"Item 1A. Risk Factors" in the Company's Quarterly Reports on Form 10-Q. We
manoeuvre in a highly competitive and speedily changing environment, thus fresh
or out of the blue risks may arise. Accordingly, investors should not place any
reliance on innovative statements as a prevision of actual results.
We disclaim whatsoever intention to, and undertake no obligation to, update or
retool any forward-looking statements. Readers are too urged to carefully
review and consider the other various disclosures in the Company's Annual
Report on Form 10-K for the year complete December 31, 2007, as well as other
public filings with the SEC since such date.
Isolagen(TM), Inc.
http://www.isolagen.com
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