{"id":1521,"date":"2021-06-21T16:45:35","date_gmt":"2021-06-21T14:45:35","guid":{"rendered":"https:\/\/hemerion.com\/solutions-therapeutiques\/essais-cliniques\/"},"modified":"2026-07-01T15:18:40","modified_gmt":"2026-07-01T13:18:40","slug":"essais-cliniques","status":"publish","type":"page","link":"https:\/\/hemerion.com\/fr\/solutions-therapeutiques\/essais-cliniques\/","title":{"rendered":"Essais Cliniques"},"content":{"rendered":"<div class=\"gb-container gb-container-24317932\"><div class=\"gb-inside-container\">\n<div class=\"gb-grid-wrapper gb-grid-wrapper-b08f467e\">\n<div class=\"gb-grid-column gb-grid-column-9efed2fb\"><div class=\"gb-container gb-container-9efed2fb\">\n\n<p class=\"gb-headline gb-headline-8fd3278d gb-headline-text lead\"><a href=\"https:\/\/hemerion.com\/fr\/solutions-therapeutiques\/\">Hemerion\u2019s technology and therapeutic concept<\/a> have undergone extensive preclinical and clinical validation studies.<br\/>The clinical development of Hemerion\u2019s solutions continues at a rapid pace. Our goal is to bring our therapies to glioblastoma patients as soon as possible. <\/p>\n\n<\/div><\/div>\n\n<div class=\"gb-grid-column gb-grid-column-ed9ef7b2\"><div class=\"gb-container gb-container-ed9ef7b2\">\n\n<h2 class=\"gb-headline gb-headline-ba530e2d gb-headline-text\">Programme d&rsquo;\u00c9tudes Sponsoris\u00e9es par les chercheurs (ISS)<\/h2>\n\n\n\n<h3 class=\"gb-headline gb-headline-43fe2d52 gb-headline-text\">Ouvrir de nouvelles voies dans le traitement du cancer<\/h3>\n\n\n\n<p class=\"gb-headline gb-headline-697e5849 gb-headline-text\">Ouvert aux chirurgiens et oncologues du monde entier, le programme ISS d&rsquo;Hemerion permet aux \u00e9quipes cliniques d&rsquo;int\u00e9grer la th\u00e9rapie combin\u00e9e Pentalafen\u00ae \/ Heliance\u00ae et ses technologies dans leurs programmes de recherche clinique et d&rsquo;innovation.<br\/>Notre objectif : repousser les limites de la th\u00e9rapie photodynamique (PDT) et am\u00e9liorer la survie et la qualit\u00e9 de vie des patients confront\u00e9s aux diagnostics les plus difficiles.<\/p>\n\n\n\n<a class=\"gb-button gb-button-b28db5c4 gb-button-text\" href=\"https:\/\/hemerion.com\/fr\/solutions-therapeutiques\/essais-cliniques\/programme-detudes-sponsorisees-par-les-chercheurs-iss\/\">Participez \u00e0 notre programme ISS<\/a>\n\n<\/div><\/div>\n<\/div>\n<\/div><\/div><div class=\"gb-container gb-container-72891610\"><div class=\"gb-inside-container\">\n<div class=\"gb-container gb-container-8e494b72\">\n\n<h3 class=\"gb-headline gb-headline-595524c5 gb-headline-text has-text-color has-brand-color-2-color\">2024<\/h3>\n\n\n\n<h2 class=\"gb-headline gb-headline-45a87160 gb-headline-text\">HTX-GBM-01 : l&rsquo;essai clinique de phase 1\/ 2 &nbsp;en cours<\/h2>\n\n\n<div class=\"gb-container gb-container-18582fb1\">\n\n<p class=\"gb-headline gb-headline-a85740fb gb-headline-text\">Inclusions termin\u00e9es, En cours de suivi<\/p>\n\n<\/div>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Suite \u00e0 l\u2019autorisation IND de la FDA re\u00e7ue le 23 avril. 23, 2023, Hemerion sponsorise actuellement un essai ambitieux pour sa th\u00e9rapie combin\u00e9e Pentalafen\u00ae\/Heliance\u00ae contre le glioblastome, en partenariat avec le centre m\u00e9dical de l\u2019Universit\u00e9 de Pittsburgh et le CHU de Lille.<br\/>Cette \u00e9tape est cruciale pour pr\u00e9parer l\u2019\u00e9tude pivot qui permettra d\u2019\u00e9valuer l\u2019efficacit\u00e9 de notre traitement. <\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Dans le d\u00e9tail<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Titre de l\u2019\u00e9tude : \u00c9tude interventionnelle, multicentrique et internationale de phase 1\/2, avec escalade de doses de lumi\u00e8re, visant \u00e0 \u00e9tudier la s\u00e9curit\u00e9 et la faisabilit\u00e9 de la th\u00e9rapie photodynamique (PDT) intra-op\u00e9ratoire avec le m\u00e9dicament Pentalafen\u00ae et le dispositif Heliance\u00ae Solution chez des patients hommes et femmes \u00e2g\u00e9s de 18 \u00e0 75 ans atteints d&rsquo;un glioblastome de grade IV.<\/li>\n\n\n\n<li>Lieu : UPMC \u00e0 Pittsburgh, PA, \u00c9tats-Unis et CHU de Lille, France.<\/li>\n\n\n\n<li>Investigateurs principaux : Jan Drappatz, MD (UMPC) et Enora Vauleon, MD (CHU de Lille)<\/li>\n\n\n\n<li>R\u00e9sum\u00e9 : L&rsquo;objectif principal de cet essai clinique est de d\u00e9terminer l&rsquo;innocuit\u00e9 et la tol\u00e9rabilit\u00e9 de deux doses de lumi\u00e8re dans la PDT perop\u00e9ratoire ajout\u00e9e \u00e0 la chimioth\u00e9rapie standard \u00e0 base de t\u00e9mozolomide chez les hommes et les femmes \u00e2g\u00e9s de 18 \u00e0 75 ans souffrant d&rsquo;un glioblastome nouvellement diagnostiqu\u00e9.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Ce traitement sera effectu\u00e9 \u00e0 la suite d\u2019une r\u00e9section chirurgicale maximale. Les donn\u00e9es recueillies au cours de cet essai seront utilis\u00e9es pour concevoir l&rsquo;\u00e9tude pivot \u00e0 venir. L&rsquo;\u00e9tude fera appel \u00e0 un comit\u00e9 ind\u00e9pendant de surveillance des donn\u00e9es et de la s\u00e9curit\u00e9 (iDSMB) qui examinera les donn\u00e9es de s\u00e9curit\u00e9 afin de permettre l&rsquo;augmentation de la dose.  <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05736406\"><strong>Plus d&rsquo;information sur ClinicalTrials.gov<\/strong><\/a><\/p>\n\n\n<div class=\"gb-container gb-container-71279ef9\">\n\n<p class=\"gb-headline gb-headline-50cd6a90\"><span class=\"gb-icon\"><svg fill=\"none\" viewbox=\"0 0 16 16\" height=\"16\" width=\"16\"> <path fill=\"#009CDF\" d=\"M8 16C10.1217 16 12.1566 15.1571 13.6569 13.6569C15.1571 12.1566 16 10.1217 16 8C16 5.87827 15.1571 3.84344 13.6569 2.34315C12.1566 0.842855 10.1217 0 8 0C5.87827 0 3.84344 0.842855 2.34315 2.34315C0.842855 3.84344 0 5.87827 0 8C0 10.1217 0.842855 12.1566 2.34315 13.6569C3.84344 15.1571 5.87827 16 8 16ZM6.75 10.5H7.5V8.5H6.75C6.33437 8.5 6 8.16562 6 7.75C6 7.33437 6.33437 7 6.75 7H8.25C8.66562 7 9 7.33437 9 7.75V10.5H9.25C9.66562 10.5 10 10.8344 10 11.25C10 11.6656 9.66562 12 9.25 12H6.75C6.33437 12 6 11.6656 6 11.25C6 10.8344 6.33437 10.5 6.75 10.5ZM8 4C8.26522 4 8.51957 4.10536 8.70711 4.29289C8.89464 4.48043 9 4.73478 9 5C9 5.26522 8.89464 5.51957 8.70711 5.70711C8.51957 5.89464 8.26522 6 8 6C7.73478 6 7.48043 5.89464 7.29289 5.70711C7.10536 5.51957 7 5.26522 7 5C7 4.73478 7.10536 4.48043 7.29289 4.29289C7.48043 4.10536 7.73478 4 8 4Z\"><\/path> <\/svg><\/span><span class=\"gb-headline-text\">Information importante<\/span><\/p>\n\n\n\n<p class=\"gb-headline gb-headline-e59f6dc3 gb-headline-text\">Si vous participez actuellement \u00e0 cet essai et que vous souhaitez d\u00e9clarer un \u00e9v\u00e9nement ind\u00e9sirable que vous pensez li\u00e9 au m\u00e9dicament Pentalafen\u00ae et\/ou au dispositif m\u00e9dical Heliance\u00ae Solution, veuillez contacter votre m\u00e9decin d&rsquo;\u00e9tude.<\/p>\n\n<\/div>\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"gb-container gb-container-68bbb080\">\n\n<h3 class=\"gb-headline gb-headline-af2f6515 gb-headline-text has-text-color has-brand-color-2-color\">2021-2023<\/h3>\n\n\n\n<h2 class=\"gb-headline gb-headline-6995c165 gb-headline-text\">DOSINDYGO : essai d&rsquo;\u00e9valuation de doses croissantes de lumi\u00e8re<\/h2>\n\n\n<div class=\"gb-container gb-container-830288fc\">\n\n<p class=\"gb-headline gb-headline-4aed3f32 gb-headline-text\">Inclusions termin\u00e9es, En cours de suivi<\/p>\n\n<\/div>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">L&rsquo;\u00e9tude DOSINDYGO fait suite \u00e0 l&rsquo;essai clinique INDYGO qui a d\u00e9montr\u00e9 en 2021 la faisabilit\u00e9 et la non-toxicit\u00e9 de la technologie Hemerion. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">DOSINDYGO vise \u00e0 tester des doses croissantes de lumi\u00e8re utilis\u00e9es par la technologie Hemerion pour \u00e9radiquer les cellules canc\u00e9reuses au plus profond du tissu c\u00e9r\u00e9bral tout en \u00e9vitant d&rsquo;endommager les tissus sains. L&rsquo;essai a \u00e9valu\u00e9 des doses de lumi\u00e8re jusqu&rsquo;\u00e0 quatre fois sup\u00e9rieures \u00e0 celles administr\u00e9es pr\u00e9c\u00e9demment dans le cadre de l&rsquo;\u00e9tude INDYGO. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Au total, 12 patients atteints de glioblastome ont \u00e9t\u00e9 trait\u00e9s depuis le lancement de l&rsquo;\u00e9tude DOSINDYGO en septembre 2021. Une premi\u00e8re \u00e9valuation clinique a \u00e9t\u00e9 r\u00e9alis\u00e9e 4 semaines apr\u00e8s chaque traitement : aucun effet ind\u00e9sirable grave li\u00e9 \u00e0 ce nouveau traitement n&rsquo;a \u00e9t\u00e9 observ\u00e9. L&rsquo;efficacit\u00e9 du traitement (prolongation de la survie globale et sans progression) n&rsquo;a pas encore \u00e9t\u00e9 \u00e9valu\u00e9e. Elle sera mesur\u00e9e \u00e0 l&rsquo;issue d&rsquo;un suivi de 24 mois pour chaque patient apr\u00e8s son op\u00e9ration.   <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04391062\"><strong>Plus d&rsquo;information sur ClinicalTrials.gov<\/strong><\/a><\/p>\n\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"gb-container gb-container-7135d373\">\n\n<h2 class=\"gb-headline gb-headline-a043cde5 gb-headline-text\">INDYGO : une premi\u00e8re clinique mondiale couronn\u00e9e de r\u00e9sultats pr\u00e9liminaires exceptionnels<\/h2>\n\n\n<div class=\"gb-container gb-container-b46702b7\">\n\n<p class=\"gb-headline gb-headline-37d81e9a gb-headline-text\">Termin\u00e9e<\/p>\n\n<\/div>\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">Une premi\u00e8re \u00e9tude clinique de faisabilit\u00e9 de la th\u00e9rapie combin\u00e9e Hemerion a \u00e9t\u00e9 commandit\u00e9e par le CHU de Lille. 10 patients recrut\u00e9s de mai 2017 \u00e0 juin 2018 ont \u00e9t\u00e9 trait\u00e9s. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Cette premi\u00e8re clinique mondiale, nomm\u00e9e INDYGO, a \u00e9t\u00e9 mise en avant dans le num\u00e9ro de septembre 2018 de Nature.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Les r\u00e9sultats pr\u00e9liminaires ont \u00e9t\u00e9 publi\u00e9s dans le Journal of Neuro-Oncology en mars 2021. Ces r\u00e9sultats d\u00e9montrent une grande tol\u00e9rance du traitement et sont tr\u00e8s encourageants en termes d&rsquo;efficacit\u00e9. En effet, les r\u00e9sultats ont \u00e9t\u00e9 nettement am\u00e9lior\u00e9s avec la moiti\u00e9 des patients trait\u00e9s ayant une survie sans progression au-del\u00e0 de 17 mois : une validation qui ouvre la voie \u00e0 des essais cliniques de phase 2.  <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03048240\"><strong>Plus d&rsquo;information sur ClinicalTrials.gov<\/strong><\/a><\/p>\n\n\n\n<div style=\"height:60px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"gb-container gb-container-d042fa7a\">\n\n<h3 class=\"gb-headline gb-headline-57d59136 gb-headline-text has-text-color has-brand-color-2-color\">2014<\/h3>\n\n\n\n<h2 class=\"gb-headline gb-headline-42160d09 gb-headline-text\">Premiers r\u00e9sultats pr\u00e9cliniques<\/h2>\n\n<\/div>\n\n\n<p class=\"wp-block-paragraph\">En 2014, une premi\u00e8re \u00e9tude pr\u00e9clinique a prouv\u00e9 l&rsquo;efficacit\u00e9 de l&rsquo;approche th\u00e9rapeutique d&rsquo;Hemerion sur des lign\u00e9es cellulaires humaines de glioblastome (GBM). Plusieurs \u00e9tudes cons\u00e9cutives ont permis \u00e0 notre \u00e9quipe d&rsquo;affiner la proc\u00e9dure th\u00e9rapeutique pour am\u00e9liorer l&rsquo;efficacit\u00e9 et la tol\u00e9rance. <\/p>\n\n\n<div class=\"gb-container gb-container-e251aae9\"><div class=\"gb-inside-container\">\n\n<div class=\"insert\">\n<img decoding=\"async\" src=\"\/wp-content\/uploads\/Icon-ionic-ios-mail-open.png\" alt=\"Ic\u00f4ne du mail\"\/>\n<div>\n<p>Restez \u00e0 l&rsquo;\u00e9coute de nos avanc\u00e9es cliniques<\/p>\n<p><a href=\"http:\/\/eepurl.com\/hovdRf\" target=\"_blank\" rel=\"noopener, noreferrer noopener\">Abonnez-vous \u00e0 notre lettre d&rsquo;information<\/a><\/p>\n<\/div>\n<\/div>\n\n<\/div><\/div>\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"gb-button-wrapper gb-button-wrapper-36394d89\">\n\n<a class=\"gb-button gb-button-ea057b46\" href=\"https:\/\/hemerion.com\/fr\/solutions-therapeutiques\/\"><span class=\"gb-icon\"><svg viewbox=\"0 0 11.534 17.863\" height=\"17.863\" width=\"11.534\">   <path fill=\"#434342\" transform=\"translate(-1.734 -6.747)\" d=\"M2.127,14.729,9.716,7.14a1.334,1.334,0,0,1,1.892,0L12.869,8.4a1.334,1.334,0,0,1,0,1.892L7.5,15.678l5.38,5.38a1.334,1.334,0,0,1,0,1.892l-1.261,1.267a1.334,1.334,0,0,1-1.892,0L2.132,16.627a1.336,1.336,0,0,1-.006-1.9Z\" data-name=\"Icon awesome-angle-left\" id=\"Icon_awesome-angle-left\"><\/path> <\/svg><\/span><span class=\"gb-button-text\">Solutions Th\u00e9rapeutiques<\/span><\/a>\n\n<\/div>\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>2024 HTX-GBM-01 : l&rsquo;essai clinique de phase 1\/ 2 &nbsp;en cours Inclusions termin\u00e9es, En cours de suivi Suite \u00e0 l\u2019autorisation IND de la FDA re\u00e7ue le 23 avril. 23, 2023, Hemerion sponsorise actuellement un essai ambitieux pour sa th\u00e9rapie combin\u00e9e Pentalafen\u00ae\/Heliance\u00ae contre le glioblastome, en partenariat avec le centre m\u00e9dical de l\u2019Universit\u00e9 de Pittsburgh et &#8230; <\/p>\n<p class=\"read-more-container\"><a title=\"Essais Cliniques\" class=\"read-more button\" href=\"https:\/\/hemerion.com\/fr\/solutions-therapeutiques\/essais-cliniques\/#more-1521\" aria-label=\"En savoir plus sur Essais Cliniques\">Lire plus<\/a><\/p>\n","protected":false},"author":207845438,"featured_media":1323,"parent":1501,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","_jet_sm_ready_style":"","_jet_sm_style":"","_jet_sm_controls_values":"","_jet_sm_fonts_collection":"","_jet_sm_fonts_links":"","_wpcom_ai_launchpad_about_page":false,"_wpcom_ai_launchpad_gallery_page":false,"_wpcom_ai_launchpad_contact_page":false,"_wpcom_ai_launchpad_events_page":false,"_wpcom_ai_launchpad_video_page":false,"_wpcom_ai_launchpad_portfolio_piece":false,"footnotes":""},"class_list":["post-1521","page","type-page","status-publish","has-post-thumbnail"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Essais cliniques \/ Cancer du cerveau \/ Glioblastome<\/title>\n<meta name=\"description\" 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