�Isolagen(TM), Inc. (Amex:
ILE) announced results from a prospective, open label, Phase II study
(IT-R-007) of Isolagen Therapy(TM) for the treatment of facial wrinkles and
creases in more or less 40 subjects. Study subjects received two
treatments of Isolagen Therapy in multiple facial regions ("full face")
approximately quintet weeks apart. The cogitation results reported improvement in
the appearance of wrinkles as scored by a high percentage both of study
subjects as substantially as of independent panel evaluators. The study results also
reported improvement in skin quality as scored by a high part of both
study subjects and participating investigators.
Six months next their final treatment ("the six-month metre
point"), 83 percent of subjects reported an improvement in their
self-assessed score of the appearance of their wrinkles. This scale was the
same as the one used in the latterly completed Isolagen Therapy polar
efficacy studies (IT-R-005 and -006). At the six-month time point, the
results from the independent jury evaluation of study photographs also
showed improvement in the appearance of wrinkles, with the independent
dialog box scoring betterment in over 75 per centum of participants.
"We ar very pleased with the outcome of this exploratory study," said
Declan Daly, President and Chief Executive Officer of Isolagen. "We are
especially interested in the responses around pelt quality, as this is
the first time we have assessed the Isolagen Therapy for these crucial
skin characteristics."
Study IT-R-007 Study Results
As seen in all previous studies of Isolagen Therapy, treatment was very
well 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 pct of bailiwick
subjects reported improvement in the appearance of their wrinkles using a
subject assessed, five-point response scale that ranged from "identical
dissatisfied" to "very quenched." Improvement was defined as a one point
move on the scale. The subject judgement scale is the same scale used in
the recently realized IT-R-005 and 006 pivotal Phase III studies of
Isolagen Therapy.
The sketch results as well included assessments from an independent panel
of trey aesthetic dermatologists and plastic surgeons world Health Organization were not
involved with the treatment of subjects in the study. Results from these
independent evaluations noted improvement in the appearance of wrinkles in
more than 75 percent of study subjects using an evaluator-assessed,
four-point scale developed for this report, ranging from "no improvement" to
"marked improvement." Improvements were assessed using photographs of
subjects taken at baseline and at the six-month time point.
Study IT-R-007 also included an assessment of skin quality 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 aforementioned their peel 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 skin characteristics ordinarily seen as the face ages and
solar damage increases. Skin quality characteristics assessed at baseline
and the final six-month see were: softness, suppleness, eloquence,
firmness, thickness, moistness, evenness in appearing and invigorated
appearance. While the Skin Quality Assessment tool is not validated,
Isolagen is evaluating this scale for future function.
"As the principal investigator in the Isolagen IT-R-007 trial, I am
optimistic about the study results which show improvement in patients'
facial appearance," said Dr. Girish Munavalli, Assistant Professor of
Dermatology at Johns Hopkins School of Medicine. "The results intimate that
improvements in both skin texture and contour may be achieved following
Isolagen treatment. I believe this final result is a unique determination in the
cosmetic injectable treatment market, utilizing the subject's have living
cells to bring home the bacon the basis for advance."
Conducted at five US sites, the primary objectives of Study IT-R-007
were to assess the base hit 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 organisation
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 discourse is created that is then returned to the
person's skin. This first of its kind aesthetical treatment, known as the
Isolagen Therapy, is intentional to better skin damage caused by the normal
effects of aging, sunday damage, acne and burns.
About Isolagen, Inc.
Isolagen(TM), Inc. (Amex: ILE) is an aesthetic and therapeutic companionship
committed to developing and commercializing scientific advances and
innovative technologies. The company's technology political platform includes the
Isolagen Process(TM), a cubicle processing system for hide 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 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 non based on historical
fact are "forward-looking statements" inside the import of the Private
Securities Litigation Reform Act of 1995 and the viands 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 any
forward-looking statements contained herein on its current expectations,
the information on which such expectations were based may variety. These
forward-looking statements bank on a number of assumptions concerning
future events and ar subject to a number of risks, uncertainties, and
other factors, many of which are outside of our ascendence, that could cause
actual results to materially differ from such statements. Such risks,
uncertainties, and other factors include, but are not of necessity limited
to, those rig 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 speedily changing environment, thus new
or unlooked-for risks crataegus laevigata arise. Accordingly, investors should not place any
trust on advanced statements as a prediction of actual results.
We disclaim whatever intention to, and set about no responsibility to, update or
retool any innovative statements. Readers are also urged to carefully
limited 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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