Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) 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.
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 WOMAC pain scale."
Michael Macaluso , Chairman and CEO of Ampio, commented "The FDA has been very helpful by recommending a single run-In study to begin our Phase III pivotal trial that will provide us deeper understanding of the treatment effect and an optimized dose that may well reduce the patient requirement, and the associated time and costs as the number of combined patients in the run-in/phase III study may be significantly less than the 1600 patients planned for the two, phase III studies in the original IND application."
Ampio Pharmaceuticals, Inc.