{"id":403394,"date":"2020-12-21T06:48:04","date_gmt":"2020-12-21T11:48:04","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=403394"},"modified":"2020-12-21T06:48:04","modified_gmt":"2020-12-21T11:48:04","slug":"aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/","title":{"rendered":"AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"left\">OCALA, Fla., Dec.  21, 2020  (GLOBE NEWSWIRE) &#8212; AIM ImmunoTech Inc. (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the U.S. Food and Drug Administration on December 17, 2020 granted Orphan Drug Designation status to AIM\u2019s drug Ampligen (rintatolimod) for the treatment of pancreatic cancer.<\/p>\n<p>The\u00a0Orphan Drug Designation program\u00a0provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the act.\u00a0The status helps incentivize the treatment of therapies to treat unmet medical needs by providing a company with seven years of exclusivity rights once a drug reaches market.<\/p>\n<p>Pancreatic cancer is the fourth leading cause of cancer deaths in the United States and the only cancer, among those most commonly diagnosed, with a five-year survival rate at just six percent, according to the Pancreatic Cancer Action Network.<\/p>\n<p>AIM <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=q-QlSZSZJJpbC8vWwpGhktpu-iaLGDfMRKDZMgKI2yfKLKebMtbdrEwno8O4aiMJXub8fSjh-BUhNnzB0b2xW79AjR_y37Gpkpb4b2_ukUHv0pqdlc_QcbKl31lkocZMzjZH-1A7wIIAV5Q9nvsICMBmCh-GxjmZ8XZSCot089jiXUvXz-pxOhaJIm4whKyvjCnISz7D2YRUBe8eV_S79ZzvnOJ4j7SB100v6uw8716xdJrSU0tI1x0TXYtEUjVf8js_ZPLPEdOWw4DrIBvRYpJYo3zcUX9jwF1x_oMLK8hk3Qnow1No8M1ix6ChCrlJ\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">recently announced<\/a> receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program conducted at Erasmus University Medical Center\u00a0in the Netherlands. The median overall survival was approximately two-fold higher \u2013 that is 200% \u2013 in the Ampligen arm, as compared to a historical control cohort matched for age, gender, stage of disease and number of cycles of Folfirinox therapy.<\/p>\n<p>\u201cThis study data demonstrates that Ampligen has the potential to extend the survival rates of people suffering with pancreatic cancer significantly when compared to the traditional standard of care for this deadly disease,\u201d said AIM CEO Thomas K. Equels.<\/p>\n<p>\n        <strong>About AIM ImmunoTech Inc.<\/strong>\n      <\/p>\n<p>AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.<\/p>\n<p>\n        <strong>Cautionary Statement<\/strong>\n      <\/p>\n<p>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as &#8220;may,&#8221; &#8220;will,&#8221; &#8220;expect,&#8221; &#8220;plan,&#8221; &#8220;anticipate,&#8221; and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The statistical analysis of the Erasmus study was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. There is no assurance that the European Medicines Agency will grant an orphan drug designation. In addition, no assurance can be given as to whether future pancreatic immuno-oncology clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.<\/p>\n<p>\n        <strong>Contacts:<\/strong>\n      <\/p>\n<p>Crescendo Communications, LLC<br \/>Phone: 212-671-1021<br \/>Email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=YMLPNAdZnpnSEgewfiWpfIM7YGebqKPS9K7eXkTHz-Ya5c7ay1WJ9mq8y-ZwQ7-m3rx-2s1rOyEnOgwGozOJOfcXbswbFxqrGIzbQ19V-7U=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">aim@crescendo-ir.com<\/a><\/p>\n<p>AIM ImmunoTech Inc<br \/>Phone: 800-778-4042<br \/>Email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=9utap7JtvE97dbnGHJUovGd1A6_BUaG36UOnCLOaD6N2zfvnGH7eBNDdtg4YOV9x4LZqVWit8y2CtcbbYMj5qQ==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">IR@aimimmuno.com<\/a><\/p>\n<p>A photo accompanying this announcement is available at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Vt0zBowVooU0hh3FN0av_j_Yz4-8xM_0l2s1pKs_z0VQwDj_RmPVHehlub74Nv7f5K0G9gVLKQxjIeNiwIyIc1HRhBDb62NRpdkItFN4j076LqaCGF4kFBlLs6UBuZ1QoNZrQjT8up-PS5jlZ5i3wHVTqRN2Qi4GbfCd5n5m1WIoEsflUg4ZM88A7iag5UUX8hCSeG6DAUgvqljg6omXX5Eb6Tb_BoWqsQNGGVUz2kRQ0VyDQUuvT7AadFW4g4AfB9-ZXmryDe39Qx3uKC5Big==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">https:\/\/www.globenewswire.com\/NewsRoom\/AttachmentNg\/a599fad2-ff32-43f6-bf01-a5728af0f680<\/a><\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExNTM4NSMzODkwMjc5IzIwMjMxNjQ=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/d839ac5f-480d-422a-92de-3c6bf20ea5fc\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>OCALA, Fla., Dec. 21, 2020 (GLOBE NEWSWIRE) &#8212; AIM ImmunoTech Inc. (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the U.S. Food and Drug Administration on December 17, 2020 granted Orphan Drug Designation status to AIM\u2019s drug Ampligen (rintatolimod) for the treatment of pancreatic cancer. The\u00a0Orphan Drug Designation program\u00a0provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the act.\u00a0The status helps incentivize the treatment of &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer&#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-403394","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>AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer - 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\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"OCALA, Fla., Dec. 21, 2020 (GLOBE NEWSWIRE) &#8212; AIM ImmunoTech Inc. (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the U.S. Food and Drug Administration on December 17, 2020 granted Orphan Drug Designation status to AIM\u2019s drug Ampligen (rintatolimod) for the treatment of pancreatic cancer. The\u00a0Orphan Drug Designation program\u00a0provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the act.\u00a0The status helps incentivize the treatment of &hellip; Continue reading &quot;AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-21T11:48:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExNTM4NSMzODkwMjc5IzIwMjMxNjQ=\" \/>\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=\"4 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\\\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer\",\"datePublished\":\"2020-12-21T11:48:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\\\/\"},\"wordCount\":753,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODExNTM4NSMzODkwMjc5IzIwMjMxNjQ=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\\\/\",\"name\":\"AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/","og_locale":"en_US","og_type":"article","og_title":"AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer - Market Newsdesk","og_description":"OCALA, Fla., Dec. 21, 2020 (GLOBE NEWSWIRE) &#8212; AIM ImmunoTech Inc. (NYSE American: AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, today announced that the U.S. Food and Drug Administration on December 17, 2020 granted Orphan Drug Designation status to AIM\u2019s drug Ampligen (rintatolimod) for the treatment of pancreatic cancer. The\u00a0Orphan Drug Designation program\u00a0provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the act.\u00a0The status helps incentivize the treatment of &hellip; Continue reading \"AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/","og_site_name":"Market Newsdesk","article_published_time":"2020-12-21T11:48:04+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExNTM4NSMzODkwMjc5IzIwMjMxNjQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer","datePublished":"2020-12-21T11:48:04+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/"},"wordCount":753,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODExNTM4NSMzODkwMjc5IzIwMjMxNjQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/aim-immunotech-inc-s-drug-ampligen-awarded-fdas-orphan-drug-designation-status-for-the-treatment-of-pancreatic-cancer\/","name":"AIM ImmunoTech Inc.\u2019s Drug Ampligen Awarded FDA\u2019s Orphan Drug Designation Status for the Treatment of Pancreatic Cancer - 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