Cytori Therapeutics Inc (NASDAQ:CYTX) announced the top-line data as part of the pre-specified partial unblinding of 24 week follow up data from the company’s ACT-OA trial. The trial is a U.S. phase II randomized, double-blind, placebo controlled trial designed to evaluate the safety and feasibility at 48 weeks of a single intra-articular knee injection of the ECCO-50 cellular therapeutic in patients with chronic knee pain due to osteoarthritis.
“Key endpoints and trends observed thus far suggest that a beneficial effect may be attributable to a single intra-articular administration of ECCO-50 in patients with osteoarthritis of the knee,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “The full 48 week data set is the next important milestone in this program. While we continue to move our clinical pipeline along, the company will remain intensely focused on bringing to market our lead therapeutic for scleroderma which is currently in phase III.”
The primary goal of the ACT-OA trial is to help determine: (1) safety and feasibility of ECCO-50 for osteoarthritis, (2) provide dosing guidance and (3) explore key trial endpoints useful for a phase III trial. As a proof of concept trial, ACT-OA was not sized or powered for statistical significance in any of the endpoints.
The purpose of the interim 24 week partial unblinding in this trial is to provide early data that will facilitate key regulatory and business development discussions and provide better understanding of the therapeutic mechanism of action that may impact other clinical programs.
The interim analysis pre-specifies the evaluation of a number of patient reported outcomes important in patients with osteoarthritis of the knee. A total of 94 patients were treated in the trial (30 received a low dose of ECCO-50 [20 million cells], 31 received a high dose of ECCO-50 [40 million cells] and 33 received placebo). Patients, providers and Cytori personnel remain blinded to individual patient treatment allocation and patient subgroup outcomes.
The interim top-line data show the following:
- The randomization is relatively balanced among the three treatment groups: low dose, high dose and placebo.
- Intra-articular application of a single dose of ECCO-50 appears to be safe and feasible in an outpatient day-surgery setting. No complications occurred related to the fat harvest, cell processing or cell delivery.
- A significant placebo response was observed, similar to that demonstrated in other OA trials.
- The pre-specified primary endpoint, pain on walking at 12 weeks, as measured by a single question from the Knee Injury and Osteoarthritis Outcome Score (KOOS) did not obtain statistical significance.
- Key secondary endpoints include the total and sub-scores of the KOOS, patient assessment of knee pain, knee stability, osteoarthritis activity and osteoarthritis damage, use of as-needed pain medication, pain while walking 50 feet and health status as measured by the SF-36. Consistent trends were observed suggesting improvement in the cell treated group relative to the placebo group at the 12 and 24 week time periods for patient reported outcomes.
- Both high dose and low dose of ECCO-50 performed similarly. (Original Source)
Shares of Cytori Therapeutics closed last Friday at $0.18. CYTX has a 1-year high of $1.47 and a 1-year low of $0.14. The stock’s 50-day moving average is $0.18 and its 200-day moving average is $0.33.
On the ratings front, Cytori Therapeutics Inc has been the subject of a number of recent research reports. In a report issued on January 25, Maxim Group analyst Jason Kolbert maintained a Buy rating on CYTX. Separately, on November 9, Roth Capital’s Joseph Pantginis maintained a Buy rating on the stock and has a price target of $2.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Joseph Pantginis have a total average return of -21.2% and -14.3% respectively. Kolbert has a success rate of 23.4% and is ranked #3581 out of 3584 analysts, while Pantginis has a success rate of 28.9% and is ranked #3572.
Cytori Therapeutics Inc is engaged in the development of novel treatments for cardiovascular disease and soft tissue injuries and burns.