{"id":405166,"date":"2020-12-23T09:58:14","date_gmt":"2020-12-23T14:58:14","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=405166"},"modified":"2020-12-23T09:58:14","modified_gmt":"2020-12-23T14:58:14","slug":"hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/","title":{"rendered":"Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients"},"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\">NEW YORK<\/span>, <span class=\"xn-chron\">Dec. 23, 2020<\/span> \/PRNewswire\/ &#8212;\u00a0Hoth Therapeutics, Inc. (NASDAQ:\u00a0HOTH), a biopharmaceutical company,\u00a0today announced the request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-001, a topical drug formation under development for the treatment of rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy. EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.html\" target=\"_blank\" rel=\"nofollow noopener noreferrer\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.jpg\" title=\"(PRNewsfoto\/Hoth Therapeutics Inc.)\" alt=\"(PRNewsfoto\/Hoth Therapeutics Inc.)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>Cancer patients receiving EGFR inhibitor therapy often require repeat courses to achieve effective cancer treatment, and &gt;50% of patients have significant dermatological side effects within the first 2 weeks of treatment that persist even after stopping EGFR therapy. These skin toxicities can severely impact patient quality of life and can result in reduction of EGFR inhibitor dose or interruption of treatment. HT-001 is targeted to treat these EGFR-induced skin disorders to allow patients to achieve the best potential outcomes of EGFR therapy, as there are currently no approved drugs to specifically treat EGFR inhibitor-induced skin disorders. <\/p>\n<p>In <span class=\"xn-chron\">July 2019<\/span> Hoth Therapeutics entered into a Sponsored Research Agreement with the <span class=\"xn-org\">George Washington University<\/span> (GW) to explore preclinical pharmacology studies with topically administered HT-001.<\/p>\n<p>Currently in the preclinical stage of development of HT-001, Hoth Therapeutics anticipates a meeting with the FDA to be scheduled during the first quarter of 2021. HT-001 is being positioned for submission via the 505(b)(2) development pathway, in which Hoth Therapeutics intends to rely on information not obtained through right of reference in order to reduce the nonclinical and clinical program and expedite time to NDA submission. During the pre-IND meeting with the FDA, Hoth Therapeutics plans to discuss the overall proposed drug development program for HT-001 including requirements for nonclinical, clinical pharmacology, clinical, and chemistry, manufacturing, controls. Hoth also plans to present clinical trial designs for the IND-opening, phase 2a dose ranging study as well as a proposed follow-up phase <span class=\"xn-money\">2b<\/span> safety and efficacy dose extension study; both studies will be conducted in cancer patients receiving EGFR inhibitor therapy. <\/p>\n<p>&#8220;Palliative care treatment for cancer patients continues to be an underserved segment of the market that our HT-001 product has an opportunity to provide patients with a better quality of life during their cancer treatment,&#8221; stated\u00a0Robb Knie, Chairman and CEO of Hoth Therapeutics.\u00a0&#8220;We look forward to working closely with the FDA on our Phase 2a and Phase <span class=\"xn-money\">2b<\/span> trial designs and advancing HT-001 through the research and development process.&#8221;<\/p>\n<p>\n        <b>About Hoth Therapeutics, Inc.\u00a0<br \/><\/b>Hoth Therapeutics, Inc. is\u00a0a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. Hoth&#8217;s pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, asthma and acne. Hoth has also recently entered into two different agreements to further the development of\u00a0two different therapeutic prospects to prevent or treat COVID-19. To learn more, please visit\u00a0<b><u><a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3021159-1&amp;h=2094252220&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3008491-1%26h%3D4053013617%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D2889507-1%2526h%253D1377821239%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D2823479-1%252526h%25253D536261162%252526u%25253Dhttp%2525253A%2525252F%2525252Fwww.hoththerapeutics.com%2525252F%252526a%25253Dwww.hoththerapeutics.com%2526a%253Dwww.hoththerapeutics.com%26a%3Dwww.hoththerapeutics.com&amp;a=www.hoththerapeutics.com%C2%A0\" rel=\"nofollow noopener noreferrer\">www.hoththerapeutics.com\u00a0<\/a><\/u><\/b>.<\/p>\n<p>\n        <b>Forward-Looking Statement\u00a0<br \/><\/b>This press release includes forward-looking statements based upon Hoth&#8217;s current expectations\u00a0which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions.\u00a0These statements concern\u00a0Hoth&#8217;s business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; our intellectual property; our reliance on third party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches; management&#8217;s expectation with respect to future acquisitions; statements regarding our goals, intentions, plans and expectations, including the introduction of new products and markets; and our cash needs and financing plans.\u00a0There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.\u00a0You should not place reliance on these forward-looking statements, which include words such as &#8220;could,&#8221; &#8220;believe,&#8221; &#8220;anticipate,&#8221; &#8220;intend,&#8221; &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;may,&#8221; &#8220;continue,&#8221; &#8220;predict,&#8221; &#8220;potential,&#8221; &#8220;project&#8221; or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled &#8220;Risk Factors&#8221; in Hoth&#8217;s most recent Annual Report on Form 10-K and Hoth&#8217;s other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth&#8217;s current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.<\/p>\n<p>\n        <b>Investor Contact:\u00a0<br \/><\/b>LR Advisors LLC\u00a0<br \/>Email:\u00a0<b><u><a target=\"_blank\" href=\"mailto:investorrelations@hoththerapeutics.com\" rel=\"nofollow noopener noreferrer\">investorrelations@hoththerapeutics.com<\/a><br \/><\/u><\/b><b><u><a target=\"_blank\" href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=3021159-1&amp;h=4214820615&amp;u=http%3A%2F%2Fwww.hoththerapeutics.com%2F&amp;a=www.hoththerapeutics.com\" rel=\"nofollow noopener noreferrer\">www.hoththerapeutics.com<\/a><br \/><\/u><\/b>Phone: (678) 570-6791<\/p>\n<p>\u00a0<\/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=NY32352&amp;sd=2020-12-23\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"http:\/\/www.prnewswire.com\/news-releases\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients-301197951.html\">http:\/\/www.prnewswire.com\/news-releases\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients-301197951.html<\/a><\/p>\n<p>SOURCE  Hoth Therapeutics, Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=NY32352&amp;Transmission_Id=202012230955PR_NEWS_USPR_____NY32352&amp;DateId=20201223\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire NEW YORK, Dec. 23, 2020 \/PRNewswire\/ &#8212;\u00a0Hoth Therapeutics, Inc. (NASDAQ:\u00a0HOTH), a biopharmaceutical company,\u00a0today announced the request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-001, a topical drug formation under development for the treatment of rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy. EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer. Cancer patients receiving EGFR inhibitor therapy often require repeat courses to achieve effective cancer treatment, and &gt;50% of patients have significant dermatological side effects within the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients&#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-405166","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients - 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\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire NEW YORK, Dec. 23, 2020 \/PRNewswire\/ &#8212;\u00a0Hoth Therapeutics, Inc. (NASDAQ:\u00a0HOTH), a biopharmaceutical company,\u00a0today announced the request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-001, a topical drug formation under development for the treatment of rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy. EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer. Cancer patients receiving EGFR inhibitor therapy often require repeat courses to achieve effective cancer treatment, and &gt;50% of patients have significant dermatological side effects within the &hellip; Continue reading &quot;Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-23T14:58:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.jpg\" \/>\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=\"5 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\\\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients\",\"datePublished\":\"2020-12-23T14:58:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\\\/\"},\"wordCount\":999,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/644804\\\/Hoth_Therapeutics_Logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\\\/\",\"name\":\"Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients - 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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\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/","og_locale":"en_US","og_type":"article","og_title":"Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients - Market Newsdesk","og_description":"PR Newswire NEW YORK, Dec. 23, 2020 \/PRNewswire\/ &#8212;\u00a0Hoth Therapeutics, Inc. (NASDAQ:\u00a0HOTH), a biopharmaceutical company,\u00a0today announced the request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-001, a topical drug formation under development for the treatment of rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy. EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer. Cancer patients receiving EGFR inhibitor therapy often require repeat courses to achieve effective cancer treatment, and &gt;50% of patients have significant dermatological side effects within the &hellip; Continue reading \"Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/","og_site_name":"Market Newsdesk","article_published_time":"2020-12-23T14:58:14+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients","datePublished":"2020-12-23T14:58:14+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/"},"wordCount":999,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-submits-request-for-a-pre-investigational-new-drug-pre-ind-meeting-for-ht-001-treatment-for-cancer-patients\/","name":"Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients - 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