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Isolagen, Inc. Submits Biologics License Application for the Treatment of Wrinkles to the U.S. Food and Drug Administration
Date:3/9/2009

EXTON, Pa., March 9 /PRNewswire-FirstCall/ -- Isolagen, Inc. (Amex: ILE) today announced that the Company has submitted a Biologics License Application (BLA) for Isolagen Therapy(TM), a novel, first-in-class cellular therapy for the treatment of wrinkles/nasolabial folds, to the U.S. Food and Drug Administration (FDA). The Company's wrinkles/nasolabial folds Phase III trials were conducted under an FDA Special Protocol Assessment.

"This BLA submission is a significant regulatory milestone for Isolagen," said Declan Daly, Chief Executive Officer and President of Isolagen. "We believe that the Isolagen Therapy(TM), if approved, would represent a new class of treatment in the facial aesthetic arena whereby patients will receive their own cells to repair the skin. We look forward to working with the FDA as it reviews our application. I am extremely proud of our employees and their efforts in accomplishing this significant goal for the Company. Further, I would like to recognize and extend my appreciation to our investigators and our regulatory and clinical advisors for all of their dedicated efforts."

Mr. Daly continued, "In addition to submitting our first BLA to the FDA, the Company has recently completed its Phase II/III trial for the treatment of acne scars with statistically significant efficacy results. I believe Isolagen represents a platform technology with an extensive pipeline of potential indications, such as the treatment of wrinkles, acne scars, burn scars and stretch marks. The Company is actively pursuing financing and/or strategic partnerships."

Update Regarding the Company's Cash Position

Isolagen currently estimates that its unrestricted, available cash resources will allow the Company to continue in operation for approximately three weeks. The Company continues to pursue poten
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SOURCE Isolagen, Inc.
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1. Isolagen, Inc. Reports Positive Top-line Results from Phase II/III Study of Isolagen Therapy(TM) to Treat Moderate to Severe Acne Scars: Study Meets All Primary Efficacy Endpoints and is Statistically Significant
2. Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant
3. Isolagen, Inc. Completes Enrollment in Isolagen Therapy(TM) Phase II/III Acne Scar Study
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