ENGLEWOOD, Colo., May 11, 2020 /PRNewswire/ -- Ampio
Pharmaceuticals, Inc. (NYSE American: AMPE), a
biopharmaceutical company focused on the development of immunology
based therapies for prevalent inflammatory conditions,
today announced a manuscript accepted for publication in
The Journal of Patient Safety in Surgery that showed Ampion
treatment could improve clinical outcomes for COVID-19
patients.
The manuscript titled, "The novel immunomodulatory
biologic LMWF5A (Ampion) for pharmacological attenuation of the
"cytokine storm" in COVID-19 patients: a hypothesis",
provides a detailed description of the biochemical and
immunological phenomena collectively termed the "cytokine storm"
encountered in COVID-19 patients and evaluates the potential
benefit of Ampion treatment for these patients. A link to the
publication will be provided on the company's website once
available.
Ampio has submitted an Investigational New Drug ("IND")
Application to the FDA for the use of nebulized Ampion to treat
COVID-19 patients with acute respiratory distress syndrome ("ARDS")
and is engaged in active discussions with the CBER division of the
FDA with the goal to obtain permission to initiaite a U.S. clinical
trial.
About Ampio Pharmaceutical
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, AmpionTM, 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 Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by the use of words such as "believe,"
"expect," "plan," "anticipate," "potential," "improve," 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, including, but not limited to,
discussions with the FDA to open an IND for AmpionTM to
treat COVID-19 patients with ARDS, the ability to receive
regulatory approval to conduct clinical trials, that Ampion may be
used to treat ARDS induced by COVID-19, that treatment with Ampion
will improve clinical outcomes of certain COVID-19 patients, 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, quarterly report of Form 10-Q
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
Dan
Stokely, CFO
Phone: (720) 437-6500
info@ampiopharma.com
Ampio Pharmaceuticals, Inc.
AMPE
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SOURCE Ampio Pharmaceuticals, Inc.