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Ampio Pharmaceuticals Announces a Proof of Concept Trial of Danazol in the Treatment of Allergic Rhinitis Supports Mechanism of Action of Optina™
Date:10/18/2011

GREENWOOD VILLAGE, Colo., Oct. 18, 2011 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that it has demonstrated in an IRB approved, randomized, placebo controlled, double-blinded proof of concept study, that low dose intranasal danazol has an impact on allergic rhinitis, a clinical condition in which increases in vascular permeability and edema are hallmark signs.

The study was not powered to show statistical significance as an effective treatment for rhinitis but rather intended to investigate the effect of danazol in a clinical condition associated with vascular permeability and edema.  After a 7 day washout period, patients were treated twice a day for 14 days with either placebo (n=10) or low-dose intranasal danazol (n=10) and assessed two times per day (AM and PM) using the validated Total Nasal Symptom Score (TNSS).  A larger decrease in TNSS indicates a greater improvement in symptoms.  A comparison of the PM score showed a strong trend toward efficacy, with a total mean change between washout and treatment of -2.39 for the treatment group compared to -0.34 for the placebo (p=0.10).  

"The pathogenesis of edema is very similar in different diseases.  The fact that low dose danazol could decrease edema in this setting is exciting, as it may indicate a similar impact of Optina™ on DME (Diabetic Macular Edema)," said Dr. Vaughan Clift, Chief Regulatory Officer of Ampio Pharmaceuticals, noting that "an oral formulation of low dose danazol (Optina™) is already the subject of a placebo-controlled, dose ranging trial in DME, the results of which are expected in Q2 2012."

About Optina(TM) (danazol)

Danazol is a weak androgen approved at high do
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SOURCE Ampio Pharmaceuticals, Inc.
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