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
(www.ampiopharma.com)
SOURCE Ampio Pharmaceuticals, Inc.