ENGLEWOOD, Colo., May 2, 2018 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that the
publication entitled: "Intra-articular injection of the
anti-inflammatory compound LMWF-5A (Ampion™) in adults with severe
osteoarthritis: a double-blind prospective randomized controlled
multicenter safety and efficacy trial" authored by Dr. Brian Cole, MD, Kristin Salottolo MPH and Dr.
David Bar-Or, MD was accepted for publication to the peer-reviewed
journal "Patient Safety in Surgery". This publication
summarizes the latest AP-003-C pivotal trial results on severe
(KL4) osteoarthritis of the knee patients as outlined
below:
This 12-week randomized, double-blind, controlled clinical
trial was conducted at thirteen sites across the United States to evaluate the
safety and efficacy of Ampion™ for the signs and symptoms of severe
osteoarthritis (Kellgren-Lawrence grade 4 disease). In total, 168
patients were randomized; 144 subjects treated with Ampion™ were
analyzed. Overall, 71% (95% CI: 63.4%–78.3%) of subjects treated
with Ampion™ met the OMERACT-OARSI responder criteria, exceeding
the 30% threshold (p< 0.001). There were also significantly more
responders at week 12 in the Ampion™ arm than historical saline
control (65% vs. 43%, p< 0.001). There was no drug-related
serious AEs reported and no deaths or withdrawals due to adverse
events. This trial demonstrates that Ampion™ provides relief for
the signs and symptoms of severe osteoarthritis, and may be an
alternative therapeutic treatment option for patients with severe
osteoarthritis of the knee. Clinicaltrials.gov:
NCT03182686.
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, the 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.