{"id":786212,"date":"2023-09-26T14:04:52","date_gmt":"2023-09-26T18:04:52","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/cel-sci-submits-scientific-advice-filing-to-european-medicines-agency-ema-for-multikine-in-the-treatment-of-head-neck-cancer\/"},"modified":"2023-09-26T14:04:52","modified_gmt":"2023-09-26T18:04:52","slug":"cel-sci-submits-scientific-advice-filing-to-european-medicines-agency-ema-for-multikine-in-the-treatment-of-head-neck-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/cel-sci-submits-scientific-advice-filing-to-european-medicines-agency-ema-for-multikine-in-the-treatment-of-head-neck-cancer\/","title":{"rendered":"CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; Neck Cancer"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; Neck Cancer<\/b><\/p>\n<p class=\"bwalignc\"><b><i>Europe has 150,000 new head &amp; neck cancer cases each year, more than twice the incidence in the U.S.<\/i><\/b><\/p>\n<p>VIENNA, Va.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nCEL-SCI Corporation <b>(NYSE American: CVM) <\/b>today reported it has filed a request for Scientific Advice regarding Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) with the European Medicines Agency\u2019s (EMA\u2019s) Scientific Advice Working Group.<\/p>\n<p>\nEurope is a high priority market for CEL-SCI, as Europe has 150,000 new annual cases of head and neck cancer, more than twice the 68,000 cases diagnosed each year in the U.S.<\/p>\n<p>\n\u201cWe look forward to discussing with the Scientific Advice Working Group the positive clinical data from our completed Phase 3 study of Multikine in head and neck cancer. The goal is to obtain the Working Group\u2019s opinion regarding this information and reach an agreement with them on a plan which will allow us to file for marketing authorization in the EU as soon as possible\u201d stated CEL-SCI\u2019s CEO Geert Kersten. \u201cThis is part of our global regulatory approval strategy. We concurrently plan to pursue filings for marketing authorization in multiple countries. There is no question about the dire need for a new and effective treatment for newly diagnosed SCCHN patients, and we are hopeful that regulators will appreciate the robust data and results from our Phase 3 study that demonstrate Multikine\u2019s efficacy and safety.\u201d<\/p>\n<p><b>About CEL-SCI Corporation<\/b><\/p>\n<p>\nCEL-SCI believes that boosting a patient\u2019s immune system while it is still intact should provide the greatest possible impact on survival. Therefore, in the Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). We believe this approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and\/or failed.<\/p>\n<p>\nMultikine is designed to help the immune system \u201ctarget\u201d the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. The Phase 3 study enrolled 928 patients.<\/p>\n<p>\nMultikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.<\/p>\n<p>\nThe Company has operations in Vienna, Virginia, and near\/in Baltimore, Maryland.<\/p>\n<p><b>Forward-Looking Statements<\/b><\/p>\n<p>\nThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words &#8220;intends,&#8221; &#8220;believes,&#8221; &#8220;anticipated,&#8221; &#8220;plans&#8221; and &#8220;expects,&#8221; and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company&#8217;s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI&#8217;s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2022. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.<\/p>\n<p><i>* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company&#8217;s future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.<\/i><\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230926468361r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20230926468361\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20230926468361\/en\/<\/a><\/span><\/p>\n<p>\nGavin de Windt<br \/>\n<br \/>CEL-SCI Corporation<br \/>\n<br \/>(703) 506-9460<\/p>\n<p><b>KEYWORDS:<\/b> Europe United States North America District of Columbia Virginia<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology General Health Health Pharmaceutical Oncology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230926468361\/en\/226967\/3\/CEL-SCI_Logo.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; Neck Cancer Europe has 150,000 new head &amp; neck cancer cases each year, more than twice the incidence in the U.S. VIENNA, Va.&#8211;(BUSINESS WIRE)&#8211; CEL-SCI Corporation (NYSE American: CVM) today reported it has filed a request for Scientific Advice regarding Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) with the European Medicines Agency\u2019s (EMA\u2019s) Scientific Advice Working Group. Europe is a high priority market for CEL-SCI, as Europe has 150,000 new annual cases of head and neck cancer, more than twice the 68,000 cases diagnosed each year in &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/cel-sci-submits-scientific-advice-filing-to-european-medicines-agency-ema-for-multikine-in-the-treatment-of-head-neck-cancer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; Neck 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-786212","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; Neck 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\/cel-sci-submits-scientific-advice-filing-to-european-medicines-agency-ema-for-multikine-in-the-treatment-of-head-neck-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; Neck Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; Neck Cancer Europe has 150,000 new head &amp; neck cancer cases each year, more than twice the incidence in the U.S. VIENNA, Va.&#8211;(BUSINESS WIRE)&#8211; CEL-SCI Corporation (NYSE American: CVM) today reported it has filed a request for Scientific Advice regarding Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) with the European Medicines Agency\u2019s (EMA\u2019s) Scientific Advice Working Group. Europe is a high priority market for CEL-SCI, as Europe has 150,000 new annual cases of head and neck cancer, more than twice the 68,000 cases diagnosed each year in &hellip; Continue reading &quot;CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; Neck Cancer&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/cel-sci-submits-scientific-advice-filing-to-european-medicines-agency-ema-for-multikine-in-the-treatment-of-head-neck-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-09-26T18:04:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20230926468361r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\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\\\/cel-sci-submits-scientific-advice-filing-to-european-medicines-agency-ema-for-multikine-in-the-treatment-of-head-neck-cancer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/cel-sci-submits-scientific-advice-filing-to-european-medicines-agency-ema-for-multikine-in-the-treatment-of-head-neck-cancer\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"CEL-SCI Submits Scientific Advice Filing to European Medicines Agency (EMA) for Multikine in the Treatment of Head &amp; 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