EXTON, Pa., Nov. 7 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. (Amex: ILE) announces the initiation of a Phase III clinical program to investigate Isolagen Therapy(TM) for the treatment of moderate to severe acne scars. Isolagen also has a pivotal Phase III clinical program underway to evaluate the Isolagen Therapy in treating nasolabial folds, or wrinkles.
"Millions of people in the U.S. suffer from acne which often scars, a condition that can be very distressing and difficult to treat as there are few options currently available," said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer of Isolagen. "We are pleased to be initiating this important clinical development program which we believe will address this largely unmet medical need."
Two randomized, double-blind, placebo-controlled trials will evaluate the safety and efficacy of Isolagen Therapy in patients with moderate to severe acne scarring on both sides of the face. All patients in the study will receive active treatment on one side of the face and placebo on the other, serving as their own control subjects. The patients will receive three injections, two weeks apart, and be followed for a four month period after final injection.
About Acne Scarring
Acne is one of the most common skin disorders in the United States. Over time, as facial tone declines and facial fat stores are depleted, acne scars typically become more noticeable. Current treatments for acne scarring include dermabrasion, laser resurfacing, surgical excision, and certain temporary fillers.
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 consists of the Isolagen Therapy. The Isolagen Therapy is a cellular processing system which creates a natural therapy of living cells by multiplying a patient's own collagen- producing cells or fibroblasts into tens of millions of new cells, creating a treatment which is then returned to the patient's skin. Clinical studies are currently underway investigating the Isolagen Therapy in aesthetic and therapeutic applications. 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. Forward-looking statements include, without limitation, the success of our Phase III clinical program to investigate Isolagen Therapy(TM) for the treatment of moderate to severe acne scars. 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, 2006, 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, 2006, as well as other public filings with the SEC since such date.
|SOURCE Isolagen, Inc.|
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