GREENWOOD VILLAGE, Colo., April 12 /PRNewswire-FirstCall/ -- Ampio Pharmaceuticals, Inc. (OTC Bulletin Board: AMPE) announced today the signing of a contract with St. Michael’s Hospital, Toronto, Canada to conduct, “A Randomized, Placebo-Controlled, Parallel Treatment Group, Double-Masked Study to Evaluate the Efficacy and Safety of Three Doses of Oral Optina™ in Adult Subjects with Diabetic Macular Edema”. This phase II trial will seek the optimal content of each dose using industry standard methods of Optical Coherence Tomography (OCT) and Best Corrected Visual Acuity (BCVA). The data will be used to construct a pivotal phase III trial for submission to regulatory bodies in the USA, Europe and Asia.
Don Wingerter, CEO of Ampio Pharmaceuticals noted that, “This is a very important step in our strategy to bring medications to the market quickly. As Optina™ is a ‘repurposed’ drug with existing manufacturing and a long-established safety profile at higher doses, our time to market outside the U.S. may be as soon as next year, which could provide near-term hope for millions of patients who experience this debilitating condition.”
The Principal Investigator, Dr. Shelley Boyd, Clinical Scientist, Department of Ophthalmology, St. Michael’s Hospital, Toronto, Canada and Assistant Professor, Department of Ophthalmology and Visual Science, University of Toronto, is a world renowned researcher into clinical therapies for the causes of loss of vision. “I am thrilled to be involved with this project for the treatment of Diabetic Retinopathy,” said Dr. Boyd. “There is a tremendous unmet need as there is no oral medication for this blinding complication of Diabetes Mellitus.”
Dr. David Bar-or, founder and Chief Scientific Officer of Ampio Pharmaceuticals, stated, “It is very gratifying to see discoveries translate from the laboratory to the clinical setting. We are very excited by the results of our in vitro data and look forward to validating the optimal therapy in patients.”
About Ampio Pharmaceuticals, Inc.
Ampio Pharmaceuticals, Inc. develops drugs to treat metabolic disease, eye disease, kidney disease, inflammation and CNS disease. The company’s product pipeline includes certain FDA approved drugs, now targeted at new clinical indications protected by Ampio intellectual property, and new molecular entities (“NMEs”). The company’s development of new uses for previously approved drugs is expected to result in reduced approval timelines, lower costs and decreased risks of clinical failure. The company is actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio’s near term and long term product development programs.
Safe Harbor Statement
This press release may contain forward-looking statements that involve risks and uncertainties, such as statements of Ampio’s plans, objectives, expectations and intentions. Forward-looking statements are generally identified by words, such as “projects,” “believes,” “anticipates,” “plans,” “expects,” “will,” and “would,” and similar expressions that are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause the actual results, performance or achievements of Ampio to be materially different from those expressed or implied by forward-looking statements. Actual events may differ materially from those mentioned in these forward-looking statements because of a number of risks and uncertainties. A discussion of factors affecting Ampio’s business and prospects is contained in Ampio’s periodic filings with the Securities and Exchange Commission, including Ampio’s Report on Form 8-K filed on March 8, 2010 with the Securities and Exchange Commission. Ampio undertakes no obligation to publicly update or revise any forward looking statements or to make any other forward-looking statements, whether as a result of new information, future events or otherwise unless required to do so by the securities laws. Investors are cautioned that forward-looking statements are not guarantees of future performance and that undue reliance should not be placed on such statements.
Investor contact: Redwood Consultants, LLC, Tel: +1 415-884-0348
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