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Isolagen, Inc. Completes Enrollment in Isolagen Therapy(TM) Phase II/III
Acne Scar Study
(press release from Isolagen(TM),
EXTON, Pa., March 14 -- Isolagen(TM), Inc.
(AMEX:ILE) announced today the completion of enrollment of approximately
120 patients in its Phase II/III Study IT-A-008 investigating the Isolagen
Therapy(TM) for the treatment of moderate to severe acne scars. Treatments,
which will be administered at seven clinical sites across the U.S., have
"We believe the Isolagen Therapy could hold great promise for the
treatment of acne scars and are pleased to have completed this important
clinical milestone as planned," said Declan Daly, Chief Executive Officer
of Isolagen. "Concerning our pivotal clinical program on wrinkle
correction, we expect to review the six month efficacy data on our Phase
III study of the Isolagen Therapy prior to September 1, 2008. We have
focused our resources to meet the goals of advancing this program and our
acne program and we are attempting to raise additional funding," continued
Daly. "We have reduced our average monthly cash burn rate, are actively
pursuing strategic partners for out-licensing, and are attempting to sell
our Switzerland facility in an effort to generate additional funds. We have
a resolute management team in place who are committed to achieving these
About the Isolagen Process(TM) and Isolagen Therapy(TM)
The Isolagen Process(TM) is an innovative cellular processing system
which creates a natural, living cell therapy. By multiplying a patient's
own collagen-producing cells or fibroblasts into tens of millions of new
cells, a personalized treatment is created which is then returned to the
patient's skin. This treatment, known as the Isolagen Therapy(TM), is
designed to improve skin damage caused by the normal effects of aging, sun
damage, acne and burns.
About Isolagen, Inc.
Isolagen(TM), Inc. (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
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. Forward-looking statements in
this press release, include, without limitation, the timely completion of
the study injections, the timely completion of the overall acne study, the
timely completion of the Company's Phase III wrinkle study, and the
Company's ability to raise additional funding, whether through strategic
partners for outlicensing, by selling its Swiss facility, or otherwise.
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 filed since the annual report. 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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