{"id":388552,"date":"2020-11-25T09:18:22","date_gmt":"2020-11-25T14:18:22","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=388552"},"modified":"2020-11-25T09:18:22","modified_gmt":"2020-11-25T14:18:22","slug":"ampio-updates-regulatory-and-clinical-trial-events","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ampio-updates-regulatory-and-clinical-trial-events\/","title":{"rendered":"Ampio Updates Regulatory and Clinical Trial Events"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p>\n        <span class=\"xn-location\">ENGLEWOOD, Colo.<\/span>, <span class=\"xn-chron\">Nov. 25, 2020<\/span> \/PRNewswire\/ &#8212; Ampio Pharmaceuticals, Inc. (NYSE American: AMPE),\u00a0a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today\u00a0the following updates:<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/479965\/Ampio_Pharmaceuticals_Logo.html\" target=\"_blank\" rel=\"nofollow noopener noreferrer\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/479965\/Ampio_Pharmaceuticals_Logo.jpg\" title=\"Ampio Pharmaceuticals Logo.  (PRNewsFoto\/Ampio Pharmaceuticals, Inc.) (PRNewsfoto\/Ampio Pharmaceuticals, Inc.)\" alt=\"Ampio Pharmaceuticals Logo.  (PRNewsFoto\/Ampio Pharmaceuticals, Inc.) (PRNewsfoto\/Ampio Pharmaceuticals, Inc.)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<ul type=\"disc\">\n<li>\n          <b>Patients experiencing respiratory distress due to COVID-19: \u00a0<\/b>In the\u00a0Phase I inhaled Ampion\u2122\u00a0clinical trial (AP-014), the third of three initial safety groups of patients\u00a0have completed their five days of treatment and three days of follow up for Safety Monitoring Committee (SMC) review (<i>as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA<\/i>). Once the SMC provides confirmation regarding no safety concerns for this third group, the trial will accelerate to complete the remaining thirty-four patients at the speed of recruitment with additional hospital groups added as required to support enrollment. <\/li>\n<li>\n          <b>Patients with severe osteoarthritis of the knee (OAK):\u00a0 <\/b>The amendment to the OAK Phase III clinical trial (AP-013), that harmonizes the FDA agreement on the Special Protocol Assessment (SPA) with FDA guidance for clinical trials on hold due to COVID-19, has been received by the FDA. The FDA notified the Company that a formal response will be provided by the end of this year.<\/li>\n<\/ul>\n<p>\n        <b>About Ampio Pharmaceutical<\/b><br \/>\n        <br \/>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.\u00a0Ampio&#8217;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).<\/p>\n<p>\n        <b>Forward Looking Statements<\/b><br \/>\n        <br \/>Ampio&#8217;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 &#8220;believe,&#8221; &#8220;expect,&#8221; &#8220;plan,&#8221; &#8220;anticipate,&#8221; and similar expressions. These forward-looking statements include statements regarding Ampio&#8217;s expectations with respect to\u00a0the 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\u00a0into 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&#8217;s ability to continue as a going concern and its ability to continue to raise funds using its &#8220;at-the-market&#8221; 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&#8217;s filings with the Securities and Exchange Commission, including without limitation, in Ampio&#8217;s Annual Report on Form 10-K for the period ended\u00a0December 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.<\/p>\n<p>\n        <b>Company Contact<\/b><br \/>\n        <br \/>Investor Relations<br \/><span class=\"xn-person\">Joe Hassett<\/span><br \/><a target=\"_blank\" href=\"mailto:joeh@gregoryfca.com\" rel=\"nofollow noopener noreferrer\">joeh@gregoryfca.com<br \/><\/a>484-686-6600<\/p>\n<p>Media Relations<br \/><span class=\"xn-person\">Sarah May<\/span><br \/><a target=\"_blank\" href=\"mailto:sarahm@gregoryfca.com\" rel=\"nofollow noopener noreferrer\">sarahm@gregoryfca.com<\/a>\u00a0<br \/>215-205-1217<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder2\"><\/div>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=LA03327&amp;sd=2020-11-25\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"http:\/\/www.prnewswire.com\/news-releases\/ampio-updates-regulatory-and-clinical-trial-events-301180238.html\">http:\/\/www.prnewswire.com\/news-releases\/ampio-updates-regulatory-and-clinical-trial-events-301180238.html<\/a><\/p>\n<p>SOURCE  Ampio Pharmaceuticals, Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=LA03327&amp;Transmission_Id=202011250915PR_NEWS_USPR_____LA03327&amp;DateId=20201125\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire ENGLEWOOD, Colo., Nov. 25, 2020 \/PRNewswire\/ &#8212; Ampio Pharmaceuticals, Inc. (NYSE American: AMPE),\u00a0a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today\u00a0the following updates: Patients experiencing respiratory distress due to COVID-19: \u00a0In the\u00a0Phase I inhaled Ampion\u2122\u00a0clinical trial (AP-014), the third of three initial safety groups of patients\u00a0have completed their five days of treatment and three days of follow up for Safety Monitoring Committee (SMC) review (as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA). Once the SMC provides confirmation regarding no safety concerns for this third group, the trial will accelerate to complete the remaining thirty-four patients at the speed of recruitment with additional hospital &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ampio-updates-regulatory-and-clinical-trial-events\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Ampio Updates Regulatory and Clinical Trial Events&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-388552","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ampio Updates Regulatory and Clinical Trial Events - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ampio-updates-regulatory-and-clinical-trial-events\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ampio Updates Regulatory and Clinical Trial Events - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire ENGLEWOOD, Colo., Nov. 25, 2020 \/PRNewswire\/ &#8212; Ampio Pharmaceuticals, Inc. (NYSE American: AMPE),\u00a0a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today\u00a0the following updates: Patients experiencing respiratory distress due to COVID-19: \u00a0In the\u00a0Phase I inhaled Ampion\u2122\u00a0clinical trial (AP-014), the third of three initial safety groups of patients\u00a0have completed their five days of treatment and three days of follow up for Safety Monitoring Committee (SMC) review (as inhalation is a new delivery method of Ampion cleared for clinical use by the FDA). 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