Isolagen completes enrolment in Phase II/III study of Isolagen Therapy
Isolagen, Inc. completed enrolment of approximately 120 patients in its phase II/III Study IT-A-008 investigating the Isolagen Therapy for the treatment of moderate to severe acne scars. Treatments, which will be administered at seven clinical sites across the US.
"We believe the Isolagen Therapy could hold great promise for the treatment of acne scars and are pleased to have completed this important clinical milestone as planned," said Declan Daly, chief executive officer, Isolagen. "Concerning our pivotal clinical program on wrinkle correction, we expect to review the six month efficacy data on our phase III study of the Isolagen Therapy prior to September 1, 2008. We have focused our resources to meet the goals of advancing this program and our acne program and we are attempting to raise additional funding," he said. "We have reduced our average monthly cash burn rate, are actively pursuing strategic partners for out-licensing, and are attempting to sell our Switzerland facility in an effort to generate additional funds. We have a resolute management team in place who are committed to achieving these goals."
The Isolagen Process 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.