ENGLEWOOD, Colo., May 22, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a poster
presentation on the mechanism of action of a component of Ampion™
will be presented at AAST and the most recent study of Ampion
treatment of Severe Osteoarthritis of the Knee ( AP-007-B) has been
accepted for publication by PSS.
Dr. David Bar-Or, Ampio's CSO explained:
- "A study was accepted for presentation as a scientific poster,
entitled "The Anti-Inflammatory Effect of LMWF5A (Ampion)
and N-Acetyl Kynurenine on Macrophages: Involvement of Aryl
Hydrocarbon Receptor in Mechanism of Action," at
the 2018 American Association for the Surgery of Trauma (AAST)
annual meeting to be held on September 26-29 in San
Diego, CA."
- "This poster details a partial mechanism of action
(MOA) for Ampion. We have reported in the previous
peer-reviewed journals that Ampion promotes the
activation of anti-inflammatory macrophages while decreasing the
activation of pro-inflammatory macrophages. In this poster, we
report that Ampion significantly decreases the
release of pro-inflammatory biomarkers from LPS-stimulated
macrophages while a known component of Ampion (N-acetyl
kynurenine or NAK) also decreased these biomarkers. When an
inhibitor of the aryl hydrocarbon receptor (AhR) was included, the
anti-inflammatory effect of Ampion was partially blocked while
the effect of NAK was completely attenuated."
- "This is an important finding since activation of the AhR
suppresses inflammation by limiting the secretion of
pro-inflammatory cytokines and promoting the overexpression of
immuno-modulatory mediators. In the literature, it is well
known that kynurenine is an agonist of AhR, but our study is the
first to describe NAK as a potential AhR
agonist. These findings suggest that Ampion and a
component (NAK) partially promote the suppression of activated
macrophages via the AhR receptor. Therefore, Ampion which
contains NAK is a useful therapeutic in medical conditions where
inflammation is prevalent such as
trauma, osteoarthritis, sepsis, and wound healing."
- "The AP-007-B study was accepted for publication in the
peer-reviewed journal Patient Safety in Surgery. The article,
entitled "Incidence of total knee replacement subsequent to
intra-articular injection of the anti-inflammatory compound
[Ampion] versus saline: a long-term follow-up study to a randomized
controlled trial" is authored by John
Schwappach, Joseph Schultz, Kristin Salottolo, and
David Bar-Or."
- "The objective of study AP-007-B was to explore the effect of
Ampion on delaying total knee arthroplasty (TKA). Patients
were recruited from the population who participated in the AP-007
trial
(www.ncbi.nlm.nih.gov/pubmed/?term=Preliminary+Trial+of+Intra-articular+LMWF-5A+for+Osteoarthritis+of+the+Knee).
A telephone survey was utilized to determine TKA status
approximately three years after treatment with Ampion or saline
vehicle control in the randomized, controlled AP-007 clinical
trial. The primary endpoint was the incidence of TKA (%), presented
by treatment arm overall and in the KL4 subset. The survey response
rate was 87%, and the overall rate of TKA was 38.5%. TKA rates were
higher in more severe osteoarthritis (KL4: 56% vs. KL3: 26%). In
the severe KL4 subset, treatment with Ampion resulted in a lower
rate of TKA compared to saline vehicle arm (40% vs. 83%). This
result supports previous findings that the treatment effect of
Ampion is greatest in patients with the more severe disease.
Further, in patients who responded to treatment during the AP-007
trial (≥20% reduction in pain), TKA rates were significantly lower
in the Ampion arm compared to the saline vehicle arm (14% vs. 100%,
respectively p=0.03). Study AP-007-B reports a meaningful
delay in TKA for patients with severe osteoarthritis treated with
Ampion, supporting the in vitro and in vivo work suggesting that
LMWF-5A has the potential to provide structure modifying/preserving
therapy in this population."
- A link to the full manuscript will be made available when it is
published online.
Regulatory Exclusivity and IP protection:
The Company
believes that Ampion™, a low molecular weight fraction of human
serum albumin with anti-inflammatory properties, will be identified
as a "reference product" upon FDA approval of their BLA.
Reference products are granted twelve years of exclusivity under
the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not
permitted to approve an application for a biosimilar or
interchangeable product until 12 years after the date of the first
licensure of the reference product. The existing Ampion™ portfolio
has patent coverage in all major jurisdictions throughout the world
(U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong
Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New
Zealand, Philippines,
Singapore, South Africa) for pharmaceutical compositions
and methods of treating a range of conditions. The portfolio
includes 125 issued patents and 85 pending applications throughout
seven primary patent families having expiration dates that extend
to 2035.
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. 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 at 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
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
Tom
Chilcott
Chief Financial Officer
Phone: (720) 437-6500
tchilcott@ampiopharma.com
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SOURCE Ampio Pharmaceuticals, Inc.