GREENWOOD VILLAGE, Colo., May 11, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion ™, Optina ™ and Zertane ™) announced completion of a pre-IND meeting with the Center for Biological Evaluation and Research (CBER) division of the FDA that took place on May 10th regarding Ampio's lead biologic, Ampion ™ for the chronic treatment (repeat injections) of pain in osteoarthritis (OA) of the knee.
The purpose of the meeting with CBER was to obtain guidance for the clinical path to a Biologics License Application (BLA) for Ampion ™ for OA of the knee in the US and clarity as to the steps necessary for Investigational New Drug (IND) submission. The discussions included manufacturing criteria and the scope and design of the phase III trial(s).
Michael Macaluso, Ampio's CEO, noted, "The Company agreed with all the guidance for Ampion ™ provided by CBER and believes the regulatory path described is both reasonable and manageable by the Company. The results of these trials (two phase III, well conducted, placebo controlled trials, run concurrently) will form the basis for a BLA submission. The scope and design of these studies will be available in our IND submission."
The Company will hold a webcast on Wednesday, May 16, 2012 at 4:15 EDT to present a 30-minute overview of the Company's progress and future plans and then open the call to a Q & A session. A press release on May 14th will describe how the shareholders and the general public can join and listen to the call.About Ampion ™ Ampion ™, a molecule protected by a composition of matter and use patents, is naturally produced by humans in response to injury and is present in commercial human serum albumin (HSA) preparations. Ampion ™ is a non-steroidal anti-inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so may have potential to treat a broad array of inflammatory conditions, which impact millions of patients.