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Ampio Announces Publication of Ampion(TM) Treatment of Severe Osteoarthritis of the Knee as a Feature Article in Orthopedics Peer-Reviewed Journal | ||
By: PR Newswire Association LLC. - 22 Nov 2017 | Back to overview list |
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ENGLEWOOD, Colo., Nov. 22, 2017 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that a manuscript entitled: "LMWF-5A for the Treatment of Severe Osteoarthritis of the Knee: Integrated Analysis of Safety and Efficacy" has been published as a feature article in Orthopedics, a peer-reviewed journal that offers clinically valuable research covering all aspects of orthopedics. https://doi.org/10.3928/01477447-20171114-05 The article describes the efficacy and safety of Ampion™ (LMWF-5A) in an integrated analysis of three single injection randomized controlled studies of severe osteoarthritis of the knee (Kellgren-Lawrence [KL] grade 4 disease). The integrated analysis included 417 patients, to our knowledge the largest report on this patient population, who have been identified by the FDA as having an unmet medical need. The end points of these studies were changes in pain, function and patient global assessment from baseline and compared to a saline control. Another outcome was the percent responder rate, defined by OMERACT-OARSI response criteria, compared to saline over a 12-week study period. Provisional benchmarks advocated by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) range from 10% to 30% for a meaningful response in the treatment of chronic pain. The article details that Ampion™ has exceeded these thresholds in all previously conducted single-injection clinical trials and is statistically significant compared with patients receiving saline (p=0.016). The primary end-point for the current pivotal trial of patients with severe osteoarthritis of the knee is responder rate compared to baseline. Patient-level response to treatment, as defined by OMERACT-OARSI criteria, addresses clinically important improvements, not just statistically significant improvements in outcomes. The article highlights the responder rate for Ampion™ in all previously conducted single-injection clinical trials (64.25%) demonstrated a meaningful response and was significantly better than the saline control (p=0.006). About Osteoarthritis About Ampio Pharmaceuticals Forward-Looking Statements Company Contact
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Copyright 2017 PR Newswire Association LLC. | Back to overview list |