GREENWOOD VILLAGE, Colo., Sept. 30, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced additional positive results from the SPRING study (clinicaltrials.gov NCT01839331) of Ampion ™ for the treatment of osteoarthritis of the knee (OAK). In this study of 329 patients, patients treated with a single intra-articular injection of Ampion ™ achieved a clinically meaningful reduction in pain. Ampio announced on August 14, 2013 that the SPRING study met its primary and key secondary endpoints.
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained "The previously reported achievement of primary end point efficacy for pain (WOMAC A, p=0.0038), function (WOMAC C, p=0.04) and Patient Global Assessment (PGA, p=0.01) at 12 weeks following a single intra-articular injection is now augmented by significant results from secondary end points. The newly announced positive results include:
- The reduction in pain compared to the vehicle control (saline) was also significant across/over the whole twelve-week period and not just at the 12 weeks end point (p=0.01).
- This study demonstrated that a single intra-articular (IA) injection of Ampion ™ resulted in a clinically and statistically significant reduction in pain, with an estimated difference from control at the study endpoint of -0.25 on the WOMAC A scale (95% CI: -0.41 to -0.08, p=0.004), corresponding to a 42.3% improvement in pain at 12 weeks in patients treated with Ampion ™.
Note: In contrast, despite recommendations against their use, Hylan G-F 20 is the current treatment of choice in patients who cannot be managed with analgesics. In the pivotal trial of a single IA injection of 6 ml Hylan G-F 20, a borderline statistically significant reduction in pain was demonstrated, with an estimated difference from control of -0.15 (95% CI: -0.30 to -0.002, p = 0.047), corresponding to a 31.3% improvement in pain over 26 weeks in patients treated with Hylan G-F20 .Note: The accepted threshold for a Minimum Clinically Important Improvement (MCII), defined as the smallest change in a measurement that signifies important improvement in a patient's symptom, is -40.8% [Ann Rheum Dis. 2005;64:29-33 Tubach F, Ravaud P, Baron G, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement] in WOMAC A pain change from baseline with knee OA, which only Ampion exceeded as an intra-articular injection.
- The Ampion ™ SPRING study included "all comers", including Kellgren-Lawrence IV patients that make up a significant portion of the "real world" osteoarthritis patients (19% in the SPRING study). Ampion ™ was not only effective overall (p=0.004) as previously reported, but was specifically effective in the subset of patients with severe osteoarthritis (Kellgren-Lawrence IV, p=0.017) who currently face a severe unmet medical need.
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