Ampio Pharmaceuticals, Inc. Completes Evaluation of Data From Phase III Clinical Trials of Zertane(TM) for Treatment of the Most Common Male Sexual Dysfunction, Premature Ejaculation
GREENWOOD VILLAGE, Colo., May 23, 2011 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE)("Ampio" or the "Company"), a company focused on new uses for previously approved drugs and new molecular entities ("NMEs"), today announced that it has completed the analysis of the data from the Phase Three European clinical trials of Zertane™, a repurposed drug used to treat premature ejaculation (PE). PE is the most common male sexual dysfunction, afflicting about 23% of all men between the ages of 18 and 75 years old. Zertane was acquired in the March, 2011 merger with DMI BioSciences, Inc.
"Completion of the Phase Three trials was particularly significant in that only about 15% of drugs that enter this phase have a successful outcome," said Dr. David Bar-Or, founder and Chief Scientific Officer. "Further, the analysis of the trial results exceeded our expectations. The data showed positive statistical significance in every category analyzed, with only very minor and minimal adverse events. This trial included 604 intent-to-treat patients, in a multi-center, double-blind, placebo-controlled design."
"Ampio currently holds issued patents in 31 countries worldwide and has multiple additional patent applications which seek to protect related clinical indications for the drug," continued Dr. Bar-Or. "This trial data is expected to allow Ampio to file a comprehensive application to selected European regulatory agencies to seek approval for commercialization of Zertane."
Ampio CEO Donald Wingerter noted: "We continue to be very encouraged by the prospects for this unique product. In the near future, Ampio will provide a presentation of the trial results that will include comparisons to published data on the only other PE drug currently marketed in Europe as well as our commercial strategic plan for this product."
The Company is also performing a phase II clinical trial of Optina™, a treatment for diabetic macular edema. Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction. 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.
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 involve risks and uncertainties, such as unexpected delays in the regulatory approval process, 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.
Ampio Pharmaceuticals, Inc.
SOURCE Ampio Pharmaceuticals, Inc.
Posted: May 2011