ENGLEWOOD, Colo., June 27, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a basic
science manuscript entitled "The Anti-Inflammatory Effect of
LMWF5A and N-Acetyl Kynurenine on Macrophages: Involvement of Aryl
Hydrocarbon Receptor in Mechanism of Action" has been accepted
for publication in Biochemistry and Biophysics Reports.
Dr. David Bar-Or, Ampio's CSO explained, "This biochemical
research uncovered an important part of the mechanism of action of
Ampion™ or the low molecular weight fraction of 5% human serum
albumin (LMWF5A). We had previously demonstrated that Ampion
promotes the activation of anti-inflammatory macrophages while
decreasing the activation of pro-inflammatory macrophages.
Here, we show that Ampion significantly decreases the release of
pro-inflammatory biomarkers from LPS-stimulated macrophages and
that one of the known components of Ampion (N-acetyl kynurenine or
NAK) also decreased these biomarkers - albeit to a smaller extent.
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 prevented.
This is a significant 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 (through) one of its active components (NAK)
promote the suppression of activated macrophages, partially via the
AhR receptor. Therefore, Ampion, which contains NAK and other
anti-inflammatory active moieties, is potentially a useful
therapeutic in medical conditions where inflammation is prevalent
such as trauma, osteoarthritis, sepsis, and wound healing."
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.