ENGLEWOOD, Colo., Dec. 10,
2020 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE
American: AMPE), a biopharmaceutical company focused on the
advancement of immunology based therapies for prevalent
inflammatory conditions, announced today that it has entered into
two collaborative research agreements to explore new clinical
indications for its immunomodulatory drug, Ampion™.
Rare Inflammatory Pediatric Diseases
The Company entered into a collaborative research agreement with
the oldest and one of the top children's hospitals in the United States whereby both parties will
work together and conduct exploratory research to determine whether
the anti-inflammatory and signaling pathways of
Ampion could play a role in the treatment of certain rare
Inflammatory Pediatric Diseases.
Currently in clinical trials for treatment of inflammation due
to osteoarthritis and COVID-19 related acute respiratory distress
syndrome (ARDS), Ampion has been shown to reduce inflammation
through multiple pathways. The exploratory research conducted under
the collaborative research agreement will utilize cell culture
models and proteomic, metabolomic, genomic and in
silico computational methods as well as in
vitro characterization of identified dysregulated
signaling pathways in human cultured cell types (e.g. human
epithelial cells, microvascular endothelial cells, peripheral blood
mononuclear cells (PBMC)).
Inflammatory Kidney Disease Research with Andrew Terker, M.D., Ph.D.
Dr. Andrew Terker, a prominent
basic research scientist specializing in kidney research at
Vanderbilt University Medical Center,
has entered into a research collaboration with Ampio in which the
immunology based anti-inflammatory properties of Ampion will be
investigated as a treatment for acute and chronic kidney disease,
extremely common conditions for which new therapies are needed. Dr.
Terker's interest in exploring Ampion's anti-inflammatory effects
in acute kidney injury (AKI) and chronic kidney disease (CKD) is
based on more than a dozen peer-reviewed publications that reported
Ampion modulates anti-inflammatory signaling pathways known to be
relevant in kidney disease. The FDA has approved three different
methods of administration of Ampion: by direct intra articular
injection, intravenous administration and by inhalation in the
course of clinical trials for the treatment of ARDS in COVID-19
patients, COVID-19 patients requiring supplemental oxygen, and
osteoarthritis of the knee. Equally important to Dr. Terker, there
have been no drug-related adverse events reported with any method
of administration in any Ampion clinical trials.
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. Ampio's lead drug, Ampion, is backed by an extensive
patent portfolio with intellectual property protection extending
through 2032 and will be eligible for 12-year FDA market
exclusivity upon approval as a novel biologic under the biologics
price competition and innovation act (BPCIA).
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 United States
Private Securities Litigation Reform Act of 1995, as amended to
date. 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 the
safety and efficacy of Ampion and its classification, as well as
those associated with regulatory approvals and other FDA decisions,
the Biologics License Application (BLA), the ability of Ampio to
enter into partnering or licensing arrangements, current or
future clinical trials, changes in business conditions and similar
events (including currently unforeseen risks associated with
COVID-19), the possibility that Ampion may be used to treat ARDS
induced by COVID-19, Ampio's ability to continue as a going concern
and its ability to continue to raise funds using its
"at-the-market" equity offering or otherwise, 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, in Ampio's Annual Report on Form 10-K
for the period ended December 31, 2019, and in subsequent
reports on Forms 10-Q and 8-K and other filings made by Ampio with
the Securities and Exchange Commission. Accordingly, you should not
place undue reliance on these forward-looking statements. 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
Investor Relations
Joe Hassett
joeh@gregoryfca.com
484-686-6600
Media Contact
Sarah
May
sarahm@gregoryfca.com
215-205-1217
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SOURCE Ampio Pharmaceuticals, Inc.