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News Breaks
August 5, 2014
08:11 EDTAMPEAmpio announces positive results from Ampion study
Ampio Pharmaceuticals announced the one month results of the open label portion of the multiple injections of Ampion into the knees of patients with osteoarthritis, or OA. Company explained "This first part of the multiple injections study involved patients receiving a series of three 4ml injections of Ampion intra-articularly. In order to proceed with the randomized vehicle- controlled portion of the trial, we had to repeat a demonstration of both safety and efficacy even though efficacy and safety had been demonstrated previously in the single injection SPRING study. No serious drug related adverse events were reported in either trial. The WOMAC A pain score improved by 65% from baseline with the multiple injections at one month post injection compared to 33% in the SPRING study at the same time point. In addition, the function score WOMAC C compared to baseline improved by 74 % at 4 weeks. The study also includes serial high resolution MRI's at various time points that will explore whether there are clinical benefits beyond pain relief."
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February 25, 2015
07:17 EDTAMPEAmpio's Ampion for osteoarthritis shows positive top-line results
Ampio announced results of the double-blind, multiple injection, vehicle controlled STRUT study at 20 weeks. The forty patient randomized phase of the STRUT study was conducted to assure that multiple injections of Ampion were safe and effective. Each patient received three 4 mL intra-articular injections of Ampion or saline at baseline, 2 weeks and 4 weeks. There were no drug related serious adverse events. The primary endpoint that is required for FDA approval, WOMAC A pain score, improved by 64% from baseline to 20 weeks. Responder rate for Ampion was 79% compared to 47% of saline patients. Data for the larger, multi-site STRIDE study, a similar design to STRUT study, is expected in Q2.

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