ENGLEWOOD, Colo., July 25, 2019 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE) today
announced the progress to date in the Company's special
protocol assessment (SPA) phase three clinical trial
titled "A Randomized, Controlled, Double-Blind Study to
Evaluate the Efficacy and Safety of an Intra-Articular Injection of
Ampion in Adults with Pain Due to Severe Osteoarthritis of the
Knee." This pivotal trial seeks to enroll approximately 1,000
patients and assess co-primary endpoints of pain and function. More
details of the study are available on clinicaltrials.gov:
https://clinicaltrials.gov/ct2/show/NCT03988023?term=ampion&cond=Osteo+Arthritis+Knee&rank=2
According to Michael Macaluso,
Ampio CEO, "Over the last two weeks, approximately two-thirds of
the scheduled sites have completed their preparations and have
begun dosing patients. As of July
24th, 280 patients have enrolled into the
study, and almost half of those patients have been dosed. The
remaining scheduled clinical sites are expected to begin enrolling
patients in August."
About Special Protocol Assessment (SPA)
A SPA is a
process in which sponsors may ask to meet with the FDA to reach
agreement on the design and size of certain clinical trials to
determine if they adequately address scientific and regulatory
requirements for a study that could support marketing approval. Our
SPA agreement for the above referenced study indicates concurrence
by the FDA with the adequacy and acceptability of specific critical
elements of overall protocol design for the study, which we intend
to support a future Biologic License Application (BLA).
About Osteoarthritis
Osteoarthritis (OA) is an
incurable and progressive disorder of the joints involving
degradation of the intra-articular cartilage, joint lining,
ligaments, and bone. Certain risk factors in conjunction with
natural wear and tear lead to the breakdown of cartilage. OA is
caused by inflammation of the soft tissue and bony structures of
the joint, which worsens over time and leads to progressive
thinning of articular cartilage. Other symptoms include narrowing
of the joint space, synovial membrane thickening, osteophyte
formation and increased density of subchondral bone.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals,
Inc. is a development stage biopharmaceutical company primarily
focused on the development of Ampion, our product candidate, to
treat prevalent inflammatory conditions for which there are limited
treatment options.
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 the use of words
such as "believe," "expect," "plan," "anticipate," and similar
expressions. These forward-looking statements include statements
regarding Ampio's expectations with respect to Ampion™ and its
classification, as well as those associated with regulatory
approvals and other FDA decisions, the Biological License
Application (BLA), the ability of Ampio to enter into
partnering arrangements, clinical trials and decisions and
changes in business conditions and similar events, all of which are
inherently subject to various risks and uncertainties. The risks
and uncertainties involved include those detailed from time to time
in Ampio's filings with the Securities and Exchange Commission,
including without limitation, under Ampio's Annual Report on Form
10-K and other documents filed with the Securities and Exchange
Commission. Ampio undertakes no obligation to revise or update
these forward-looking statements, whether as a result of new
information, future events or otherwise.
Company Contact
Phone: (720) 437-6500
info@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.