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Ampio Provides Progress Report on Clinical Programs in Preparation for Annual Shareholders Meeting
Date:11/14/2012

GREENWOOD VILLAGE, Colo., Nov. 14, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (AMPE), a biopharmaceutical company developing repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction is providing this update on its recent activities ahead of its scheduled shareholder meeting that will take place on December 15, 2012. 

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"Our goal is to commercialize our extensive drug and patent portfolio to the benefit of our shareholders," said Michael Macaluso, CEO. "We are now entering the pivotal clinical trial phase for the three drugs and one diagnostic device which have most near term promise and will soon either be licensed, sold, partnered or directly distributed by Ampio. Once this is accomplished, we will move up other drugs from our pipeline into the development phase."

The update is as follows:

Ampion™

Ampion™ is a unique anti-inflammatory biologic being developed for the treatment of osteoarthritis of the knee.

  • Ampio entered into a manufacturing agreement with Sypharma (Australia) for the production of Ampion™ for intra articular injection. The initial production run was completed and the stability-testing program, conducted in parallel to the clinical trials, is underway.
  • Ampio has recently met with the CBER division of the FDA and received guidance for the conduct of pivotal trials for approval in the USA. Both open label and placebo controlled trials will be conducted over the next year to provide the full 1,500 patient exposure for safety and clinical efficacy data.  The recent FDA discussions have indicated that if the results of these trials mirror the successful outcomes seen in the Australian
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SOURCE Ampio Pharmaceuticals, Inc.
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