AMPIO Receives Special Protocol Assessment from FDA; Commences Second Phase III pivotal trial of Ampion

Ampio Pharmaceuticals, Inc. (NYSE MKT:

) today announced it has commenced the second Phase III Study of Ampion™ to treat pain and inflammation due to osteoarthritis (OA) of the knee. Details of the clinical trial design are available on our website, www.ampiopharma.com and will also be uploaded to Clinicaltrials.gov. A Special Protocol Assessment (SPA) is a written agreement between the FDA and the sponsor company (Ampio Pharmaceuticals), which defines the clinical trial end points required for approval and significantly reduces the risk of bringing a drug to market.  "We greatly appreciate the effort by the FDA in reviewing the extensive data and protocols we submitted before granting the SPA," stated Vaughan Clift, MD, Chief Medical Officer. "The Ampion™ drug and control saline were manufactured in our state-of-the-art, cGMP facility in Colorado.  Our sites have been carefully chosen and the site personnel and monitors have been thoroughly trained on the protocol and administration of the WOMAC 3.1 pain index. The pre-trial preparation has been extensive." Michael Macaluso, Ampio's CEO, noted, "We have been awarded multiple patents to protect the