{"id":725596,"date":"2023-01-25T06:03:33","date_gmt":"2023-01-25T11:03:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\/"},"modified":"2023-01-25T06:03:33","modified_gmt":"2023-01-25T11:03:33","slug":"immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\/","title":{"rendered":"Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">MELBOURNE, Australia, Jan.  25, 2023  (GLOBE NEWSWIRE) &#8212; Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, today announces that a response letter has been submitted to the US Food and Drug Administration (FDA). Immuron has previously reported feedback was received from the FDA following a review of the Investigational New Drug (IND) application (ASX announcement July 26, 2022) of a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. The FDA informed the NMRC that based on its review of the nonclinical data, the agency was placing a clinical hold on the clinical trials of the new oral therapeutic under the IND application.<\/p>\n<p align=\"justify\">The Sponsor Investigator and Principal Investigator from Johns Hopkins University (JHU) Bloomberg School of Public Health and personnel from the Naval Medical Research Center (NMRC) and Immuron participated in a virtual meeting with the FDA on the 2 December 2022 to discuss the clinical hold and advise on a path forward to address the safety concerns and supporting data associated with this new product. The FDA provided written guidance to the NMRC following the meeting on the 20 December 2022. NMRC, JHU and Immuron have now addressed the specific concerns of the FDA clinical hold and a response letter has been submitted. The agency will provide feedback on the clinical hold in 30 calendar days from receipt of the NMRC information package.<\/p>\n<p align=\"justify\">This release has been authorised by the directors of Immuron Limited.<\/p>\n<p align=\"left\">\n        <strong>\u00a0 COMPANY CONTACT:<\/strong>\n      <\/p>\n<p align=\"left\">\n        <strong>\u00a0 Steven Lydeamore<\/strong><br \/>\n        <br \/>\u00a0 Chief Executive Officer<br \/>\u00a0 Ph: +61 (0)3 9824 5254<br \/>\u00a0 info@immuron.com<\/p>\n<p align=\"justify\">\n        <strong>About Immuron<\/strong><br \/>\n        <br \/>Immuron Limited (ASX: IMC, NASDAQ: IMRN) is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.<\/p>\n<p align=\"justify\">For more information visit: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ue7iPZbVI8lENGZDXyLWF9Z3gu76L6KBU0aB--tF5EOkgK16kUatUdP_bVzw4OPNNKc3doYAPjyYDo30TABGgvPBPh24RKwIq-99SogOawo=\" rel=\"nofollow noopener\" target=\"_blank\">http:\/\/www.immuron.com<\/a><\/p>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODczNTQ2MSM1MzcxNDI4IzIwMjAyOTM=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/YWE0YTI1MmItYjc1OS00OWFlLWExODUtMmE4NWEzZWZkMjg5LTEwMzE4NjU=\/tiny\/Immuron-Limited.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>MELBOURNE, Australia, Jan. 25, 2023 (GLOBE NEWSWIRE) &#8212; Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, today announces that a response letter has been submitted to the US Food and Drug Administration (FDA). Immuron has previously reported feedback was received from the FDA following a review of the Investigational New Drug (IND) application (ASX announcement July 26, 2022) of a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. The FDA informed the NMRC that based on its review of the nonclinical data, the agency was placing a clinical hold on the clinical trials of &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic&#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-725596","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>Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic - 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\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"MELBOURNE, Australia, Jan. 25, 2023 (GLOBE NEWSWIRE) &#8212; Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, today announces that a response letter has been submitted to the US Food and Drug Administration (FDA). Immuron has previously reported feedback was received from the FDA following a review of the Investigational New Drug (IND) application (ASX announcement July 26, 2022) of a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. The FDA informed the NMRC that based on its review of the nonclinical data, the agency was placing a clinical hold on the clinical trials of &hellip; Continue reading &quot;Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-01-25T11:03:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODczNTQ2MSM1MzcxNDI4IzIwMjAyOTM=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic\",\"datePublished\":\"2023-01-25T11:03:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\\\/\"},\"wordCount\":317,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODczNTQ2MSM1MzcxNDI4IzIwMjAyOTM=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/immuron-us-dod-naval-medical-research-center-responds-to-fda-clinical-hold-for-new-campylobacter-etec-therapeutic\\\/\",\"name\":\"Immuron US DoD Naval Medical Research Center responds to FDA Clinical Hold for New Campylobacter ETEC Therapeutic - 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