ENGLEWOOD, Colo., Nov. 22, 2017 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that a
manuscript entitled: "LMWF-5A for the Treatment of Severe
Osteoarthritis of the Knee: Integrated Analysis of Safety and
Efficacy" has been published as a feature article in
Orthopedics, a peer-reviewed journal that offers clinically
valuable research covering all aspects of
orthopedics. https://doi.org/10.3928/01477447-20171114-05
The article describes the efficacy and safety of Ampion™
(LMWF-5A) in an integrated analysis of three single injection
randomized controlled studies of severe osteoarthritis of the knee
(Kellgren-Lawrence [KL] grade 4 disease). The integrated analysis
included 417 patients, to our knowledge the largest report on this
patient population, who have been identified by the FDA as having
an unmet medical need.
The end points of these studies were changes in pain, function
and patient global assessment from baseline and compared to a
saline control. Another outcome was the percent responder rate,
defined by OMERACT-OARSI response criteria, compared to saline over
a 12-week study period.
Provisional benchmarks advocated by the Initiative on Methods,
Measurement, and Pain Assessment in Clinical Trials (IMMPACT) range
from 10% to 30% for a meaningful response in the treatment of
chronic pain. The article details that Ampion™ has exceeded these
thresholds in all previously conducted single-injection clinical
trials and is statistically significant compared with patients
receiving saline (p=0.016).
The primary end-point for the current pivotal trial of patients
with severe osteoarthritis of the knee is responder rate compared
to baseline. Patient-level response to treatment, as defined by
OMERACT-OARSI criteria, addresses clinically important
improvements, not just statistically significant improvements in
outcomes. The article highlights the responder rate for Ampion™ in
all previously conducted single-injection clinical trials (64.25%)
demonstrated a meaningful response and was significantly better
than the saline control (p=0.006).
About Osteoarthritis
Osteoarthritis (OA) is a
progressive disorder of the joints involving degradation of the
intra-articular cartilage, joint lining, ligaments, and bone. The
incidence of developing osteoarthritis of the knee over a lifetime
is approximately 45%. As this disease is associated with age,
obesity, and diabetes, this number will continue to grow. Certain
risk factors in conjunction with natural wear and tear lead to the
breakdown of cartilage. Osteoarthritis 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 therapies to treat prevalent
inflammatory conditions for which there are limited treatment
options. We are developing compounds that decrease inflammation by
(i) inhibiting specific pro-inflammatory compounds by affecting
specific pathways at the protein expression and the transcription
level; (ii) activating specific phosphatase or depletion of the
available phosphate needed for the inflammation process; and (iii)
decreasing vascular permeability.
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 scientific publications on our Ampion™ product.
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 Quarterly Reports on Form 10-Q. 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
Tom
Chilcott
Chief Financial Officer
Phone: (720) 437-6500
tchilcott@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.