Company Update (NASDAQ:CYTX): Cytori Therapeutics Inc Completes Enrollment in US Phase IIb Osteoarthritis Trial
By Corey Williams
Cytori Therapeutics Inc (NASDAQ:CYTX) announced that enrollment has been completed in its US Phase IIb Osteoarthritis trial. The ACT-OA trial is a double-blind randomized, placebo-controlled trial evaluating the safety, feasibility and dosing of intraarticular administration of Cytori’s ECCO-50 cellular therapeutic in patients with knee osteoarthritis. A total of 94 patients were enrolled as of June 12, 2015.
“Based on faster than anticipated enrollment, we now expect to have six month follow up data for review in Q1 2016. We are very encouraged by the rate of recruitment, which was completed months ahead of the original plan,” said Marc Hedrick, CEO and President, Cytori Therapeutics. “Based on 24 week follow-up outcomes, we will provide an update on the data and the Phase 3 design, including the size of the trial, cost and end points.”
“The rate of enrollment and interest in the procedure is indicative of the overall medical need of a validated cell therapy or biologic approach to osteoarthritis. Not only has the enrollment rate exceeded our expectations, we have found that the clinical procedure characterized by tissue harvest, bedside autologous cellular therapeutic manufacture and therapeutic delivery was readily adapted to the day surgery setting without difficulty. In fact, one center in the study performed three procedures with a single Celution system,” said Dr. Brian Cole, a Principal Investigator of the ACT-OA trial, and Professor and Vice-Chairman,Department of Orthopedics, Department of Anatomy and Cell Biology, Section Head, Cartilage Restoration Center at Rush,Rush University Medical Center.
