Healthcare Industry News:  autologous cell 

Regenerative Medicine FDA

 News Release - October 13, 2006

Isolagen and FDA Reach Agreement on Phase III Protocol Design

Company to Commence Pivotal Phase III Trials of Isolagen(TM) Therapy for the Treatment of Wrinkles

EXTON, Pa., Oct. 13 (HSMN NewsFeed) -- 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.


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:

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.

Source: Isolagen

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.