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").
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 [email protected] Ampio Pharmaceuticals, Inc. AMPE