Isolagen Inc announced that the Company's regulatory affairs group met with the United States Food and Drug Administration (FDA) and presented their plan for regulatory approval on its Investigational New Drug Application (IND) for Autologous Fibroblasts (human, dermal, Isolagen Technologies Inc) Expanded Ex. Vivo, Administered Intradermally, for the treatment of wrinkles and scars due to acne, chickenpox or minor trauma. Isolagen presented to the FDA that it would begin the pivotal trial to prepare for a Biological License Application (BLA).
Dr. Vaughan Clift, Vice President of Operations, stated, "We anticipate starting our pivotal trial on or before May 15, 2003. We are very pleased with our progress to date with not only the scientific improvements to our process, but as important, the clinical results we are experiencing with our commercial patients in the United Kingdom. Clearly, the United States market is a critical market for Isolagen, and once approved, we look forward to achieving success and market acceptance domestically, adding to our growing acceptance overseas."
Frank DeLape, Chairman, stated, "The Company is very pleased that it has defined the regulatory FDA roadmap to license approval and that the Company will continue its international expansion through its existing European and Pacific Rim production facilities."