Isolagen Initiates Phase III Clinical Program to Investigate Isolagen Therapy(TM) for the Treatment of Acne Scars
November 07 2007 - 2:22PM
PR Newswire (US)
EXTON, Pa., Nov. 7 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc.
(AMEX:ILE) announces the initiation of a Phase III clinical program
to investigate Isolagen Therapy(TM) for the treatment of moderate
to severe acne scars. Isolagen also has a pivotal Phase III
clinical program underway to evaluate the Isolagen Therapy in
treating nasolabial folds, or wrinkles. "Millions of people in the
U.S. suffer from acne which often scars, a condition that can be
very distressing and difficult to treat as there are few options
currently available," said Nicholas L. Teti, Jr., Chairman and
Chief Executive Officer of Isolagen. "We are pleased to be
initiating this important clinical development program which we
believe will address this largely unmet medical need." Two
randomized, double-blind, placebo-controlled trials will evaluate
the safety and efficacy of Isolagen Therapy in patients with
moderate to severe acne scarring on both sides of the face. All
patients in the study will receive active treatment on one side of
the face and placebo on the other, serving as their own control
subjects. The patients will receive three injections, two weeks
apart, and be followed for a four month period after final
injection. About Acne Scarring Acne is one of the most common skin
disorders in the United States. Over time, as facial tone declines
and facial fat stores are depleted, acne scars typically become
more noticeable. Current treatments for acne scarring include
dermabrasion, laser resurfacing, surgical excision, and certain
temporary fillers. 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 consists of the
Isolagen Therapy. The Isolagen Therapy is a cellular processing
system which creates a natural therapy of living cells by
multiplying a patient's own collagen- producing cells or
fibroblasts into tens of millions of new cells, creating a
treatment which is then returned to the patient's skin. Clinical
studies are currently underway investigating the Isolagen Therapy
in aesthetic and therapeutic applications. 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. Forward-looking
statements include, without limitation, the success of our Phase
III clinical program to investigate Isolagen Therapy(TM) for the
treatment of moderate to severe acne scars. 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, 2006, 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, 2006, as well as other public filings with the SEC since such
date. DATASOURCE: Isolagen, Inc. CONTACT: Media, Mike Beyer of Sam
Brown Inc., +1-773-463-4211, , for Isolagen; or Investors, Charles
Huiner of Isolagen, +1-484-713-6200, Web site:
http://www.isolagen.com/
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