{"id":32662,"date":"2020-12-08T10:51:20","date_gmt":"2020-12-08T09:51:20","guid":{"rendered":"https:\/\/www.inovallee.com\/?p=32662"},"modified":"2020-12-08T10:51:20","modified_gmt":"2020-12-08T09:51:20","slug":"nh-theraguix-obtient-lautorisation-de-la-fda-et-lance-ses-premiers-essais-cliniques-aux-etats-unis-avec-le-dana-farber-and-brigham-womens-hospital-a-boston","status":"publish","type":"post","link":"https:\/\/www.inovallee.com\/en\/nh-theraguix-obtient-lautorisation-de-la-fda-et-lance-ses-premiers-essais-cliniques-aux-etats-unis-avec-le-dana-farber-and-brigham-womens-hospital-a-boston\/","title":{"rendered":"NH TherAguix obtient l\u2019autorisation de la FDA et lance ses premiers essais cliniques aux \u00c9tats-Unis avec le Dana Farber and Brigham & Women’s Hospital \u00e0 Boston !"},"content":{"rendered":"

NH TherAguix<\/a> (\u00ab\u00a0NHT\u00a0\u00bb) vient de recevoir l\u2019acceptation de la Food and Drug Administration (\u00ab\u00a0FDA\u00a0\u00bb) am\u00e9ricaine pour sa demande d’autorisation de mise sur le march\u00e9 (\u00ab\u00a0IND\u00a0\u00bb) de son candidat-m\u00e9dicament AGuIX, qui doit \u00eatre combin\u00e9 \u00e0 la radioth\u00e9rapie pour augmenter l’efficacit\u00e9 de la radioth\u00e9rapie pour les cancers solides.<\/p>\n

C\u2019est le Dana Farber and Brigham & Women’s Hospital (DFBWH, Harvard Medical School, Boston) qui sera le promoteur du premier essai clinique aux aux \u00c9tats-Unis, dont le d\u00e9marrage est premier trimestre 2021 sous le nom NANOSMART PhIb-II.<\/p>\n

Cette \u00e9tude est con\u00e7ue comme une \u00e9tude randomis\u00e9e avec deux bras de traitement pour les patients diagnostiqu\u00e9s soit avec un cancer du pancr\u00e9as localement avanc\u00e9, soit avec un cancer du poumon non \u00e0 petites cellules centralement localis\u00e9. La radioth\u00e9rapie sera effectu\u00e9e \u00e0 l’aide d’une machine IRM-Linac, permettant une radioth\u00e9rapie guid\u00e9e par l’image apr\u00e8s injection intraveineuse d’AGuIX.<\/p>\n

\u00ab\u00a0Passer le cap de l’IND et donc pouvoir r\u00e9aliser des essais cliniques avec un centre renomm\u00e9 comme le DFBWH est une \u00e9tape tr\u00e8s importante pour le NHT\u00a0\u00bb se r\u00e9jouit G\u00e9raldine Le Duc, PDG.<\/p>\n

\u00c0 propos d’AGuIX : <\/strong><\/p>\n

AGuIX est une nanom\u00e9decine bimodale, avec un effet radiosensibilisant et visible en IRM. AGuIX a d\u00e9montr\u00e9 une bonne s\u00e9curit\u00e9 post-injection, une am\u00e9lioration du contraste en IRM et une preuve pr\u00e9coce de radiosensibilisation lorsqu’il est combin\u00e9 \u00e0 une radioth\u00e9rapie chez des patients pr\u00e9sentant des m\u00e9tastases c\u00e9r\u00e9brales (essai NANORAD1 Phase-Ib, CHU de Grenoble, France). AGuIX est actuellement test\u00e9 dans le cadre de deux essais de phase II sur les m\u00e9tastases c\u00e9r\u00e9brales, en utilisant soit la radioth\u00e9rapie du cerveau entier, soit la radiochirurgie st\u00e9r\u00e9otaxique. En parall\u00e8le, un essai de phase Ib pour le cancer avanc\u00e9 du col de l’ut\u00e9rus (NANOCOL1) est en cours \u00e0 l’Institut Gustave Roussy \u00e0 Paris.<\/p>\n

A propos de NH TherAguix :\u00a0 <\/strong><\/p>\n

NH TherAguix, dont le si\u00e8ge est au Tarmac, travaille sur une innovation en nanom\u00e9decine, le candidat m\u00e9dicament AGuIX, dont l’efficacit\u00e9 clinique potentielle repose sur une structuration nanom\u00e9trique permettant son injection intraveineuse et la combinaison de trois propri\u00e9t\u00e9s essentielles pour lutter contre les tumeurs : le ciblage, l’imagerie et le traitement. La technologie AGuIX s’inscrit donc dans le concept de th\u00e9ranostic, qui correspond \u00e0 une combinaison de th\u00e9rapie (effet radiosensibilisant) et de diagnostic (visible en IRM), et plus largement dans la m\u00e9decine personnalis\u00e9e du futur. Le pipeline d’essais cliniques de la soci\u00e9t\u00e9 est actuellement ax\u00e9 sur la neuro-oncologie avec 2 essais de phase II sur les m\u00e9tastases c\u00e9r\u00e9brales et recrute actuellement (NANORAD2, radioth\u00e9rapie du cerveau entier et NANOSTEREO, radiochirurgie st\u00e9r\u00e9otaxique) et un essai de phase Ib\/II sur le gliobalstome qui sera lanc\u00e9 au d\u00e9but de 2021 (NANOGBM). En outre, des essais dans des indications primaires sont en cours (NANOCOL, cancer avanc\u00e9 du col de l’ut\u00e9rus) et pr\u00e9vus, comme l’essai NANOSMART cit\u00e9 plus haut.<\/p>","protected":false},"excerpt":{"rendered":"

NH TherAguix (\u00ab\u00a0NHT\u00a0\u00bb) vient de recevoir l\u2019acceptation de la Food and Drug Administration (\u00ab\u00a0FDA\u00a0\u00bb) am\u00e9ricaine pour sa demande d’autorisation de mise sur le march\u00e9 (\u00ab\u00a0IND\u00a0\u00bb) de son candidat-m\u00e9dicament AGuIX, qui doit \u00eatre combin\u00e9 \u00e0 la radioth\u00e9rapie pour augmenter l’efficacit\u00e9 de la radioth\u00e9rapie pour les cancers solides. C\u2019est le Dana Farber and Brigham & Women’s Hospital […]<\/p>\n","protected":false},"author":4,"featured_media":32663,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[45,44],"tags":[239,157],"class_list":["post-32662","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-startup-tarmac","category-tarmac-incubator","tag-biotech","tag-nh-theraguix"],"yoast_head":"\nNH TherAguix obtient l\u2019autorisation de la FDA et lance ses premiers essais cliniques aux \u00c9tats-Unis avec le Dana Farber and Brigham & Women's Hospital \u00e0 Boston ! - inovall\u00e9e<\/title>\n<meta name=\"description\" content=\"NH TherAguix re\u00e7oit l'autorisation de mise sur le march\u00e9 de son candidat-m\u00e9dicament AGuIX, pour augmenter l'efficacit\u00e9 de la radioth\u00e9rapie pour les cancers solides.\" \/>\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.inovallee.com\/en\/nh-theraguix-obtient-lautorisation-de-la-fda-et-lance-ses-premiers-essais-cliniques-aux-etats-unis-avec-le-dana-farber-and-brigham-womens-hospital-a-boston\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"NH TherAguix obtient l\u2019autorisation de la FDA et lance ses premiers essais cliniques aux \u00c9tats-Unis avec le Dana Farber and Brigham & Women's Hospital \u00e0 Boston ! 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