SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ: CYTX) announced today 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 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.”
“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.
Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
1http://www.cdc.gov/arthritis/basics/osteoarthritis.htm (accessed 2 Feb 2015)
2American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee: evidence-based guideline 2nd edition. http://www.aaos.org/research/guidelines/treatmentofosteoarthritisofthekneeguideline.pdf (accesed 2 Feb 2015)