Isolagen and FDA Reach Agreement on Phase III Protocol Design
October 13 2006 - 12:54PM
PR Newswire (US)
Company to Commence Pivotal Phase III Trials of Isolagen(TM)
Therapy for the Treatment of Wrinkles EXTON, Pa., Oct. 13
/PRNewswire-FirstCall/ -- Isolagen, Inc. (AMEX:ILE) announced today
that the Company has reached an agreement with the Food and Drug
Administration (FDA) on the design of its Phase III pivotal study
protocol for the use of Isolagen(TM) Therapy for the treatment of
wrinkles. The protocol was submitted to the FDA under the agency's
Special Protocol Assessment (SPA) regulations. The SPA process
allows for FDA evaluation of a clinical trial protocol that will
form the basis of an efficacy claim for a marketing application,
and provides a binding agreement that the study design -- including
patient numbers, clinical endpoints, and analyses -- are acceptable
to the FDA. "We are very pleased that the FDA has completed the SPA
review process and agreed with our protocol design," said Nicholas
L. Teti, Isolagen Chairman and Chief Executive Officer. "We are
eager to begin the Isolagen Therapy registration trials for the
treatment of wrinkles and plan to begin enrolling patients as soon
as possible. This is a key milestone for the Company. I applaud our
clinical and regulatory team for this achievement." The randomized,
double-blind, pivotal Phase III trials will evaluate the efficacy
and safety of Isolagen(TM) Therapy (IT) against placebo for the
treatment of nasolabial skin fold wrinkles. Each trial will include
200 patients. ABOUT ISOLAGEN, INC. Isolagen specializes in the
development and commercialization of autologous cellular therapies
for soft and hard tissue regeneration. The company's product
candidates are based on its proprietary Isolagen Process.
Autologous cellular therapy is the process whereby a patient's own
cells are extracted, allowed to multiply and then injected into the
patient. Isolagen's product candidates are designed to be minimally
invasive and non-surgical. For additional information, please
visit: http://www.isolagen.com/. 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 (which Sections were
adopted as part of the Private Securities Litigation Reform Act of
1995). 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, 2005, 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. There is no assurance that the study
that is the focus of the SPA disclosed above will be successful,
that Isolagen(TM) Therapy will ever gain approval to be marketed in
the United States or if approved will be marketed in the United
States, or that if marketed that it will achieve its objectives or
that the Company will achieve profitable operations. 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, 2005, as
well as other public filings with the SEC since such date.
DATASOURCE: Isolagen, Inc. CONTACT: Investors: Lee M. Stern, The
Trout Group, +1-212-477-9007, ; Media: Mike Beyer, Sam Brown Inc.,
+1-773-463-4211, Web site: http://www.isolagen.com/
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