Ampio Pharmaceuticals receives FDA IND approval to start clinical trial of Ampion

Apr 2 2013

Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) today announced FDA acceptance of its IND and the treatment of the first fifteen (15) patients in its clinical trial using Ampion™ to treat osteoarthritis (OA) of the knee.

Dr. Vaughan Clift , Ampio's Chief Regulatory Officer noted, "We are grateful to the FDA for suggesting our trial design include a run-in portion to assure an optimized dose.  This randomized, placebo-controlled, double-blind trial proceeds in two parts. This study design will allow us to present two well-conducted clinical trials for a biologic license application (BLA). The first run-in portion of the trial, designated as the "Spring Study" will evaluate two doses of Ampion™ in 320 adult patients suffering from moderate to severe OA of the knee. This run-in portion will determine the optimal dosage of Ampion™ that will be used in the second portion of the pivotal trial.  The number of patients required in the second part of the study will be determined based on an analysis of the first part."

Michael Macaluso , Chairman and CEO of Ampio, commented "We are excited to begin executing this two-part, run-in trial design because it may allow us to determine indications of efficacy with fewer patients.  Our principal investigators inform us that the high prevalence of OA of the knee may allow for the completion of both portions of the pivotal trial in an abbreviated timeframe."