Ampio Pharmaceuticals Announces Phase 3 Ampion Study for Osteoarthritis of the Knee to Include a Dose-Escalation Run-in Study

Ampio Pharmaceuticals

announced today that it's Phase III clinical study of Ampion for the treatment for osteoarthritis of the knee will include a dose-escalation run-in study as recommended by the FDA.  (Logo:  http://photos.prnewswire.com/prnh/20120516/MM09116LOGO) Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, explained "In the Australian trial, a single 4 ml dose provided promising results from the Ampion™ treated patients suffering from osteoarthritis. This run-in portion of the Phase III trial that will be launched in the US is designed primarily to determine if the 4 mL treatment could be improved by administering a 10 ml volume of Ampion™, the volume commonly injected into the knee with other therapeutic agents." Dr. Clift further noted "Accordingly, the Company has modified the original study design to accommodate the FDA recommendations and submitted this upgraded IND study protocol for clearance to begin treating patients. A Clinical Research Organization (CRO) has been engaged and multiple clinical sites have been selected that are ready to enroll patients in the study. The dose ranging run-in study will commence shortly and will include 320 patients in total comparing 4 ml to 10 ml injection using the