Isolagen and FDA Reach Agreement on Phase III Protocol Design
October 13 2006 - 10:00AM
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/. This press release includes
statements that 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. While management has based any forward-looking statements
contained in the release 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
Isolagen's 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 the caption "Item 1A. Risk Factors" in Isolagen's most
recent Form 10-K filing, as updated in "Item 1A. Risk Factors" in
Isolagen's most recent Form 10-Q filing. In addition, Isolagen
operates in a highly competitive and rapidly changing environment,
and new risks may arise. Accordingly, investors should not place
any reliance on forward-looking statements as a prediction of
actual results. Isolagen disclaims any intention to, and undertakes
no obligation to, update or revise any forward-looking statement.
Readers are also urged to carefully review and consider the various
disclosures in Isolagen's annual report on Form 10-K, filed with
the SEC on March 14, 2006, 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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