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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ampio Pharmaceuticals Inc | AMEX:AMPE | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.62 | 0 | 01:00:00 |
ENGLEWOOD, Colo., Dec. 17, 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 it has completed its Phase I clinical trial and has initiated the first steps for a global Phase II clinical trial for intravenous ("IV") Ampion treatment in COVID-19 patients.
The Phase I study was a randomized, controlled study of adults hospitalized with severe COVID-19. The primary endpoint for the study was evaluated after a 5-day treatment period, and safety was followed for an additional 3 months. Half of the patients received IV Ampion plus the standard of care ("SOC") for COVID-19 while the other half received SOC alone. The following highlights were observed:
The beneficial clinical applications for IV Ampion treatment in COVID-19 patients will be further explored using two treatment groups in a larger Phase II study while building on the safety profile from the Phase I study. The following highlights are presented:
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 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, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, 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
Investor Relations
Joe Hassett
joeh@gregoryfca.com
484-686-6600
Media Contact
Sarah May
sarahm@gregoryfca.com
215-205-1217
View original content to download multimedia:http://www.prnewswire.com/news-releases/ampion-demonstrates-safety-in-covid-19-patients-and-initiates-global-clinical-trial-for-intravenous-ampion-301195209.html
SOURCE Ampio Pharmaceuticals, Inc.
Copyright 2020 PR Newswire
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