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news.Submission of biologics license application for Isolagen Therapy
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Isolagen, an aesthetic and therapeutic company, has announced positive top-line efficacy results from a Phase II/III clinical study of the Isolagen Therapy for the treatment of moderate to severe acne scars.
According to Isolagen, the study met all primary efficacy endpoints and was statistically significant, making this a major clinical milestone for the company. 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 US.
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% of patients reported a response to the Isolagen Therapy-treated side of the face, while 18% of patients reported a response on the placebo-treated side of the face.
With respect to the evaluator assessments, evaluators reported that 59% of patients responded on the Isolagen Therapy-treated side of the face, and that 42% 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, the company said.
The company is preparing to submit its biologics license application for Isolagen Therapy for the treatment of wrinkles/nasolabial folds and currently expects this submission to occur shortly.
Declan Daly, president and CEO of Isolagen, said: 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. 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.