Isolagen, Inc. Reports Positive Top-line Results from Phase II/III Study of Isolagen Therapy(TM) to Treat Moderate to Severe Acne Scars
- Category: DNA RNA and Cells
- Published on Thursday, 05 March 2009 01:00
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Study Meets All Primary Efficacy Endpoints and is Statistically Significant
Company Provides Update on Cash Position
Biologics License Application for Wrinkles/Nasolabial Folds Indication Expected To Be Filed Within Two Weeks
EXTON, PA, USA | March 5, 2009 | Isolagen(TM), Inc. (Amex: ILE - News) announced today positive top-line efficacy results from a Phase II/III clinical study (Study IT-A-008) of the Isolagen Therapy(TM) for the treatment of moderate to severe acne scars. The study met all primary efficacy endpoints and was statistically significant, making this a major clinical milestone for the Company.
"This is very exciting, positive data which continues to support the potential of the Isolagen Therapy as a platform technology for aesthetic and therapeutic indications," said Declan Daly, President and Chief Executive Officer of Isolagen, Inc. "There is a great need globally for the treatment of acne scars and we believe that the Isolagen Therapy has a significant role to play in this largely untapped market."
The Phase II/III, placebo-controlled study investigating the efficacy and safety of Isolagen Therapy(TM) for the treatment of moderate to severe acne scars evaluated a total of 109 people at seven clinical sites across the United States. In the study, both the Patient and Evaluator assessments met the co-primary endpoints and were statistically significant, achieving p-values of 0.000011 and 0.016, respectively (p-values less than or equal to 0.05 are considered statistically significant).
With respect to the Patient assessments, 43 percent of patients reported a response to the Isolagen Therapy-treated side of the face, while 18 percent of patients reported a response on the placebo-treated side of the face. With respect to the Evaluator assessments, evaluators reported that 59 percent of patients responded on the Isolagen Therapy-treated side of the face, and that 42 percent of patients responded on the placebo-treated side of the face. The safety data for this study are currently under review; however, no serious adverse events related to Isolagen Therapy were reported during the course of the study.
"I am very excited about the study results and the activity seen with the use of the Isolagen Therapy to treat acne scars," said Girish Munavalli, MD, MHS, Medical Director, Dermatology, Laser and Vein Specialists of the Carolinas, Charlotte, North Carolina. "As the co-primary investigator in this study, I have seen firsthand the benefit of the Isolagen Therapy on acne scars and the impact the result has on my patients. This is a unique product and may be life changing for patients with acne scarring."
Stacy Smith, MD, Assistant Clinical Professor, Division of Dermatology, University of California San Diego, and the study's other co-primary investigator further commented, "I am very pleased with the outcome of this study. There are minimal options currently available for the treatment of acne scars and the results of this study, coupled with my clinical experience with the Isolagen Therapy, show that this treatment has the potential to become a significant product for acne scarring."
The Isolagen Process(TM) is a proprietary cellular processing system that creates a natural, living cell therapy. By multiplying a person's own collagen-producing cells, or fibroblasts, into tens of millions of new cells, a personalized treatment is created that is then returned to the person's skin. This first of its kind aesthetic 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 the Phase II/III Acne Scar Study
The goal of the Phase II/III multicenter, double-blind, randomized, placebo-controlled study was to demonstrate the efficacy of three treatments of Isolagen Therapy on one side of the face as compared with placebo treatment on the other side of the face for the treatment of moderate to severe acne scars. The primary efficacy endpoints are measured four months following the last study treatment, using the following co-primary endpoints:
-- Patient Live Acne Scarring Assessment: The Patients' live assessment of the acne scarring of each cheek, using a 5point assessment scale, with a response defined as a 2-point improvement as compared to baseline, and an
-- Evaluator Live Acne Scar Assessment: The Evaluators' live assessment of the acne scarring of the treatment area on each cheek, using a 5-point assessment scale and photoguide, with a response defined as a 1-point improvement as compared to baseline.
Isolagen's Phase II/III study for moderate to severe acne scars was conducted under an FDA Investigational New Drug Application. Although statistically significant, these results do not guarantee approval of a commercial license or a labeling claim for this indication. The Company believes that to ultimately obtain FDA approval with respect to the acne scar indication, the Company will require FDA concurrence with the use of the Company's Evaluator Live Acne Scar Assessment scale, which the Company developed specifically for use in this study and which has not been previously used in a clinical trial. Further, if the Company obtains this concurrence from the FDA, then the Company will also require, at a minimum, one additional Phase III study to complement study IT-A-008 in order to pursue FDA approval and licensure.
Update Regarding Isolagen's Cash Position and the Biologics License Application for Wrinkles/Nasolabial Folds
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 potential financing alternatives and potential strategic partnership discussions. However, there can be no assurance that any such potential financing alternative will be completed on terms acceptable to the Company, or successfully completed at all. Further, there can be no assurance that any potential strategic partnership discussions will be completed on terms acceptable to the Company, or completed at all. If the Company does not obtain additional funding, or anticipate additional funding in the very near future, the Company may enter into bankruptcy, and possibly cease operations. In addition, as previously disclosed, the Company currently has a debt liability of approximately $89.7 million related to its 3.5% subordinated notes, which could be called due, at the option of the note holders, as early as November 2009. Interest on the notes is due semiannually on May 1 and November 1.
Further, the Company is pursuing the potential sale of its 57% ownership interest in Agera Laboratories, Inc. There can be no assurance that a sale of this ownership interest will be completed on terms acceptable to the Company, or successfully completed at all.
The Company is preparing to submit its Biologics License Application (BLA) for Isolagen Therapy(TM) for the treatment of wrinkles/nasolabial folds and currently expects this submission to occur within two weeks.
About Isolagen, Inc.
Isolagen(TM), Inc. (Amex: ILE - News) 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® Laboratories, Inc. For additional information, please visit www.isolagen.com.
SOURCE: Isolagen Inc.