Isolagen Completes Pivotal Efficacy Portion of Phase III Studies of Isolagen Therapy(TM) for Wrinkles
02 Julio 2008 - 9:00AM
PR Newswire (US)
- Top-line Data Expected in August - EXTON, Pa., July 2
/PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (AMEX:ILE) announced
today the completion of the pivotal efficacy portion of its Phase
III clinical studies (IT-R-005/006) investigating the Isolagen
Therapy(TM) for the treatment of nasolabial folds, or wrinkles. The
last person in each study has completed the primary efficacy
follow-up visit, and collation of this data has begun. The Company
anticipates that top-line efficacy and safety data analyses from
the studies will be reported in August 2008. "The completion of the
pivotal efficacy portion of our Phase III clinical studies is a
major milestone for Isolagen," said Declan Daly, Chief Executive
Officer of Isolagen. "I commend the Isolagen team and our
investigators for their efforts and look forward to announcing the
data once it is un-blinded later this summer." 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, is designed to improve skin damage 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 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, our ability to timely report the
top-line efficacy and safety data from the Phase III studies during
August 2008. 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. DATASOURCE: Isolagen,
Inc. CONTACT: Mike Beyer of Sam Brown Inc., +1-773-463-4211, , for
Isolagen, Inc. Web site: http://www.isolagen.com/
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