Ampio Initiates Pivotal Trial of Ampion ™
ENGLEWOOD, Colo., May 1, 2017 -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announces initiation of a single injection study to meet the "unmet medical need" of treating the severe pain and loss of function associated with Kellgren-Lawrence (KL) grade 4 osteoarthritis of the knee (OAK) with a primary endpoint that follows the Osteoarthritis Research Society International (OARSI) guidance, utilizing the Outcome Measures in Rheumatology Clincal Trials (OMERACT) OMERACT-OARSI responder rate.
Dr. David Bar-Or, Ampio's Chief Science Officer, clarified, "In compliance with FDA guidance, this trial will be smaller than our prior trials with 171 patients, randomization of 6 to 1 (Ampion™/Saline) on patients with severe OAK, defined radiologically as KL 4 patients.
- Published: 01 May 2017
- Written by Editor