February 8, 2016 7:56am
Data suggest beneficial effect of ECCO-50 for knee osteoarthritis: full data set expected Q3 2016
The who, what and purpose of the interim 24 week partial un-blinding in this trial is to provide early data that will facilitate key regulatory and business development discussions and provide a better understanding of the therapeutic mechanism of action that may impact other clinical programs.
It is still about the impact of the news to the share pricing and ... capitalization.
CYTX announced today the top-line data as part of the pre-specified partial un-blinding of 24 week follow up data from the company’s ACT-OA trial.
The trial is a U.S. P2 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.
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 Bottom Line: 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 P3 trial.
An important point, the proof of concept trial, ACT-OA was not sized or powered for statistical significance in any of the endpoints.
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.
In summary, patterns of response are suggestive of a beneficial effect attributable to a single intra-articular administration of ECCO-50 in patients with osteoarthritis of the knee. The full 48 week data are expected to be available for review during Q3/16, which will more fully inform further development decisions, including P3 trial design, cell dose, administration protocol, inclusion/exclusion criteria, selection of primary and secondary endpoints and sample size.
CYTX closed at $0.18. Another great news positive generating a BUY ranking but, will it be dissipated by the low and lower share pricing. A reverse is needed to validate any upward spiral from news such as this.
