July 2, 2008
Isolagen Completes Pivotal Efficacy Portion of Phase III Studies of Isolagen Therapy(TM) for Wrinkles
EXTON, Pa., July 2 /PRNewswire-FirstCall/ -- Isolagen(TM), Inc. announced today the completion of the pivotal efficacy portion of its Phase III clinical studies (IT-R-005/006) investigating the Isolagen Therapy(TM) for the treatment of nasolabial folds, or wrinkles. The last person in each study has completed the primary efficacy follow-up visit, and collation of this data has begun. The Company anticipates that top-line efficacy and safety data analyses from the studies will be reported in August 2008.
"The completion of the pivotal efficacy portion of our Phase III clinical studies is a major milestone for Isolagen," said Declan Daly, Chief Executive Officer of Isolagen. "I commend the Isolagen team and our investigators for their efforts and look forward to announcing the data once it is un-blinded later this summer."
About the Isolagen Process(TM) and Isolagen Therapy(TM)
The Isolagen Process(TM) is an innovative cellular processing system which creates a natural, living cell therapy. By multiplying a patient's own collagen-producing cells or fibroblasts into tens of millions of new cells, a personalized treatment is created which is then returned to the patient's skin. This treatment, known as the Isolagen Therapy, is designed to improve skin damage caused by the normal effects of aging, sun damage, acne and burns.
About Isolagen, Inc.
Isolagen(TM), Inc. is an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies. The company's technology platform includes the Isolagen Process(TM), a cell processing system for skin and tissue rejuvenation which is currently in clinical development for a broad range of aesthetic and therapeutic applications including wrinkles, acne scars, burns and periodontal disease. 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. Such statements include, without limitation, our ability to timely report the top-line efficacy and safety data from the Phase III studies during August 2008. 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, 2007, 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, 2007, as well as other public filings with the SEC since such date.
CONTACT: Mike Beyer of Sam Brown Inc., +1-773-463-4211,[email protected], for Isolagen, Inc.
Web site: http://www.isolagen.com/