Isolagen, Inc announced positive top-line efficacy results from a phase-II/III clinical study (Study IT-A-008) of the Isolagen Therapy 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 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 per cent of patients reported a response to the Isolagen Therapy-treated side of the face, while 18 per cent of patients reported a response on the placebo-treated side of the face. With respect to the Evaluator assessments, evaluators reported that 59 per cent of patients responded on the Isolagen Therapy-treated side of the face, and that 42 per cent 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, 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, 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 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.
Isolagen is an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies.