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.
The availability of safety and efficacy data in Q1 2016 will lead to informed decisions and discussions with the FDA regarding the study design and size of an osteoarthritis Phase III program with Cytori Cell Therapy.
Osteoarthritis is a disease of the entire joint involving the cartilage, joint lining, ligaments, and underlying bone. The breakdown of tissue leads to pain, joint stiffness and reduced function. It is the most common form of arthritis and affects an estimated 26.9 million US adults.1 Current treatments include physical therapy, non-steroidal anti-inflammatory medications, viscosupplement injections, and total knee replacement. The American Academy of Orthopedic Surgeon’s guidelines for the treatment of osteoarthritis of the knee noted that there were few non-surgical treatments that could be recommended2, which highlights the potential for Cytori Cell Therapy to address a large inadequately addressed medical need. (Original Source)
Shares of Cytori Therapeutics closed last Friday at $0.6812 . CYTX has a 1-year high of $2.53 and a 1-year low of $0.36. The stock’s 50-day moving average is $0.71 and its 200-day moving average is $0.76.
On the ratings front, Cytori Therapeutics has been the subject of a number of recent research reports. In a report issued on April 23, Maxim Group analyst Jason Kolbert reiterated a Buy rating on CYTX, with a price target of $7, which represents a potential upside of 927.6% from where the stock is currently trading. Separately, on April 6, Laidlaw’s Yale Jen reiterated a Buy rating on the stock and has a price target of $4.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Yale Jen have a total average return of 2.7% and 35.2% respectively. Kolbert has a success rate of 42.0% and is ranked #1223 out of 3624 analysts, while Jen has a success rate of 60.0% and is ranked #692.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.