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Isolagen And FDA Reach Agreement On Phase III Protocol Design
(press release from Isolagen, Inc.)
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
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
"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
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: 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.
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