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

trials it will be sufficient for registration as a chronic use therapy and an IND is being prepared.
  • Multiple sites for the conduct of the trials have been identified and several CRO proposals were received and are being evaluated.
  • Ampio has an extensive portfolio of patents for Ampion™ and expects additional patents to be awarded, worldwide that encompass composition of matter, uses and synthesis patents.
  • Optina™

    Optina™ is an orally administered ultra-low dose of danazol for the treatment of diabetic macular edema (DME).

    • A phase 2a clinical trial conducted in Canada demonstrated encouraging results.
    • Scientific, peer-reviewed manuscripts, on the mechanism of action of the Optina™ were recently published in BBRC (Biochem Biophys Res Commun. 2012 May 18;421(4):707-12) and as a cover story was published in Retina Today (October 2012 issue).
    • Ampio has obtained the active ingredient, danazol, for the Optina clinical trial from CIPLA (Mumbai, India).
    • Ampio entered into a contractual agreement for the formulation of Optina™ with Green Mountain (Denver, Colorado) to produce the ultra-low doses of Optina™, which will be used in the forthcoming phase 2b clinical trials in the USA and elsewhere. The trials will be conducted under a 505(b)2 pathway in adherence to  guidance provided by the FDA at a pre-IND meeting and an IND application is being prepared.
    • Ampio will conduct pivotal trials in Europe (sites identified) for this indication.
    • Ampio was recently awarded multiple patents both in the USA and worldwide for Optina™.
    • Ampio is engaged in discussions with potential partners for Optina™.

    Sexual Dysfunction drugs

    This program includes Zertane™, for the treatment of premature ejaculation (PE), and Zertane ED™, for the treatment of com
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    SOURCE Ampio Pharmaceuticals, Inc.
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