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News Breaks
August 6, 2014
08:38 EDTCYTXCytori Therapeutics downgraded to Hold from Buy at Ascendiant
News For CYTX From The Last 14 Days
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February 10, 2016
07:07 EDTCYTXCytori to present two year Scleroderma data at Systemic Sclerosis World Congress
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February 8, 2016
07:01 EDTCYTXCytori Therapeutics reports interim data on U.S. Phase II osteoarthritis trial
Cytori Therapeutics 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. "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, 31 received a high dose of ECCO-50. Patients, providers and Cytori personnel remain blinded to individual patient treatment allocation and patient subgroup outcomes.
February 3, 2016
07:15 EDTCYTXCytori says Cytori Cell Therapy 'safe' and 'effective' in EU Phase 1 ED trial
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