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 doses for the treatment of endometriosis, fibrocystic disease of the breast and hereditary angioedema. In this trial a low dose of a nasal formulation of danazol was used. Ampio, which has filed multiple patent applications for a number of re-purposed clinical indications for danazol, has previously demonstrated that at low in-vitro concentrations, danazol significantly inhibits TNF-a- and IL-1b-induced vascular permeability in human tissues, a mechanism that is not seen at higher doses.
About the Allergic Rhinitis Study
This was a proof of concept study designed to validate the mechanism of action for low-dose danazol, to indicate potential efficacy, to elucidate the study methods, and determine the number of patients required to achieve statistical significance. Twenty patients were randomized to receive either intranasal danazol or placebo twice a day during a two week double-blind period which followed a one week washout period. The subjects reported reflective total nasal symptom scores (rTNSS) as well as instantaneous total nasal symptom scores (iTNSS) every 12 hours. A trend of improvements in rTNSS was observed in all parameters in the intranasal danazol group but not in the placebo group.
Dr. Isaac Melamed, Director of Immuno-E, Centers for Allergy and Asthma in Denver, Colorado, who conducted the study, noted that “I am optimistic about the results of this proof of concept study. Patients in the treatment group reported improvement in all categories of allergic rhinitis. I would encourage Ampio to continue development of this product to treat allergic rhinitis and related conditions.”
About Ampio
Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities (“NMEs”). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio’s product development programs.
For more information about Ampio, please visit our website, www.ampiopharma.com.
Forward-Looking Statements
Ampio’s statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
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SOURCE Ampio Pharmaceuticals, Inc.
