Navigation Links
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 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.

Contact: -- Investor Relations --
Ampio Pharmaceuticals, Inc.-- 720-437-6500


'/>"/>
SOURCE Ampio Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ampio Pharmaceuticals Receives Notice of Allowance of its Two Patent Applications on the Combination of Zertane™ with Erectile Dysfunction Drugs in Canada
2. Ampio Announces Positive Results From 12-Week Open Label Extension Study of Zertane™ in Patients With Premature Ejaculation.
3. Champions Oncology Reports Fiscal 2012 First Quarter Financial Results
4. Ampio Pharmaceuticals Executes License and Development Agreement with Daewoong Co. Ltd. to Commercialize Zertane™ in South Korea
5. Ampio Pharmaceuticals Announces Treatment of First Patient in Phase 1b Ampion-In -Knee (AIK) Trial for Osteoarthritis in Australia
6. Ampio Pharmaceuticals, Inc. Releases Results From Phase III Clinical Trial of Zertane™ for the Treatment of Premature Ejaculation (PE), the Most Prevalent Form of Male Sexual Dysfunction
7. Ampio Pharmaceuticals Set to Join Russell 3000 Index
8. Ampio Pharmaceuticals, Inc. Appoints New Independent Director
9. Ampio Pharmaceuticals, Inc. to Begin Trading on the NASDAQ Capital Market
10. Ampio Pharmaceuticals, Inc. Receives Approval to List on the NASDAQ Capital Market
11. Five Californians Selected as Breakaway from Cancer® Champions to be Honored During Amgen Tour of California
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/23/2017)... , March 23, 2017 ... and Healthcare disease pipeline guide Primary Hyperoxaluria - ... the Primary Hyperoxaluria (Genito Urinary System And Sex ... rare condition characterized by recurrent kidney and bladder ... substance called oxalate. Symptoms include blood in the ...
(Date:3/23/2017)... Research and Markets has announced the addition of the ... ... oxygen therapy devices market to grow at a CAGR of 10.16% ... Therapy Devices Market 2017-2021, has been prepared based on an in-depth ... market landscape and its growth prospects over the coming years. The ...
(Date:3/23/2017)... , March 23, 2017  Additive Orthopaedics, LLC., ... that it has kicked off a multi-centered clinical ... printed bone segments. According to ... variable honeycomb lattice structures have already shown tremendous ... to current allograft wedges from which we have ...
Breaking Medicine Technology:
(Date:3/23/2017)... ... March 23, 2017 , ... A recent report from ... into teacher preparation programs. The NCTQ report suggests, based on a review of GPA ... significantly improve teacher quality in the U.S. It argues that this higher bar should ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... services to their communities, 16 more public health departments have been awarded national ... bring another 4.5 million people into the expanding network of communities across the ...
(Date:3/23/2017)... ... March 23, 2017 , ... PAINWeekEnd (PWE) Oklahoma ... North Broadway Avenue, will be an educational and exciting program providing busy clinicians ... management of chronic pain. , Oklahoma is in a healthcare crisis. The state ...
(Date:3/23/2017)... ... ... The MBI “Hall of Fame” recognizes the contributions of those whose careers are or were ... careers of all others involved. , On Monday, March 21st, 2017 Laurie Robert, ... Fame. The induction took place during the World of Modular – Award Gala in ...
(Date:3/23/2017)... ... March 23, 2017 , ... ... and businesses of the Norwalk and Vermillion areas, celebrates the newest charity ... is a nonprofit, community-based substance abuse prevention and peer recovery support organization ...
Breaking Medicine News(10 mins):