{"id":25235,"date":"2024-04-03T14:59:40","date_gmt":"2024-04-03T14:59:40","guid":{"rendered":"https:\/\/dupmecp2.eu\/?p=25235"},"modified":"2025-07-23T10:39:41","modified_gmt":"2025-07-23T08:39:41","slug":"badania-kliniczne-huidagenu","status":"publish","type":"post","link":"https:\/\/dupmecp2.eu\/pl\/badania-kliniczne-huidagenu\/","title":{"rendered":"HuidaGene: w kierunku bada\u0144 klinicznych"},"content":{"rendered":"

W lutym 2024 r. David Covini, prezes DupMECP2, odwiedzi\u0142 firm\u0119 biotechnologiczn\u0105 HuidaGene Therapeutics w Szanghaju. Wizyta by\u0142a wyj\u0105tkow\u0105 okazj\u0105 do spotkania z dynamicznym zespo\u0142em, kt\u00f3rego kandydat kliniczny mo\u017ce zrewolucjonizowa\u0107 przysz\u0142o\u015b\u0107 leczenia zespo\u0142u duplikacji genu MECP2 (MDS). <\/p>\n\n\n\n

Kierowana przez CEO HuidagGene, dr Alvina Luka, firma jest liderem w opracowywaniu rewolucyjnej technologii, kt\u00f3ra mo\u017ce zmieni\u0107 \u017cycie dzieci dotkni\u0119tych MDS. Wizyta by\u0142a niesamowit\u0105 okazj\u0105 do odkrycia najnowocze\u015bniejszych obiekt\u00f3w i kreatywnego \u015brodowiska, kt\u00f3re wspiera takie badania. Warto zauwa\u017cy\u0107, \u017ce przestrze\u0144 biurowa obejmuje nawet \u015bciank\u0119 wspinaczkow\u0105, co sprzyja kreatywnej atmosferze pracy. <\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

Alvin i jego dyrektor medyczny ds. MDS, dr Gloria Tang, przedstawili szczeg\u00f3\u0142y technologii edycji RNA CRISPR CAS13 dla zespo\u0142u duplikacji gen\u00f3w. MECP2<\/em>o nazwie HG204. Obiecuj\u0105ca jako\u015b\u0107 danych i wst\u0119pne wyniki bada\u0144 toksyczno\u015bci na naczelnych doprowadzi\u0142y HuidaGene do ekscytuj\u0105cego rozwoju. Badanie kliniczne firmy, pocz\u0105tkowo zaplanowane na drug\u0105 po\u0142ow\u0119 2024 r., otrzyma\u0142o ju\u017c zgod\u0119 komisji etycznej od dw\u00f3ch szpitali, a jego celem jest w\u0142\u0105czenie pacjent\u00f3w z MDS przed ko\u0144cem roku.<\/p>\n\n\n\n

To doskona\u0142a wiadomo\u015b\u0107 dla spo\u0142eczno\u015bci MDS. Nadchodz\u0105ce badanie kliniczne HG204 dla MDS, zwane \"HERO\", b\u0119dzie pocz\u0105tkowo leczy\u0107 co najmniej 4 pacjent\u00f3w, kt\u00f3rzy b\u0119d\u0105 \u015bci\u015ble monitorowani przez rok. Pierwsza faza tego prze\u0142omowego badania zostanie przeprowadzona w Chinach. W\u0142\u0105czenie kolejnych pacjent\u00f3w w Chinach b\u0119dzie zale\u017ca\u0142o od pierwszych wst\u0119pnych wynik\u00f3w badania interwencyjnego.<\/p>\n\n\n\n

HuidaGene poczyni\u0142a ju\u017c znaczne post\u0119py w kierunku zatwierdzenia przez organy regulacyjne, uzyskuj\u0105c dwa oznaczenia FDA (Rare Paediatric Disease Designation (RPDD) i Orphan Drug Designation (ODD)) dla HG204. Nawi\u0105zali r\u00f3wnie\u017c kontakt z FDA i EMA w celu przeprowadzenia dodatkowych bada\u0144 w USA i Europie. <\/p>\n\n\n\n

To zaszczyt, \u017ce mogli\u015bmy osobi\u015bcie pozna\u0107 Alvina i Glori\u0119. Cieszymy si\u0119, \u017ce mo\u017cemy by\u0107 cz\u0119\u015bci\u0105 tej przygody i z niecierpliwo\u015bci\u0105 czekamy na informowanie naszej spo\u0142eczno\u015bci o post\u0119pach w tej potencjalnie zmieniaj\u0105cej \u017cycie technologii.<\/p>\n\n\n\n

<\/p>","protected":false},"excerpt":{"rendered":"

En f\u00e9vrier 2024, David Covini, pr\u00e9sident de DupMECP2, a visit\u00e9 l’entreprise de biotechnologie HuidaGene Therapeutics \u00e0 Shanghai. Cette visite a \u00e9t\u00e9 une occasion unique de rencontrer une \u00e9quipe dynamique dont […]<\/p>","protected":false},"author":1,"featured_media":25367,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-25235","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite"],"yoast_head":"\nHuidaGene: vers les essais cliniques - DupMECP2<\/title>\n<meta name=\"description\" content=\"En f\u00e9vrier 2024, David Covini, pr\u00e9sident de DupMECP2, a visit\u00e9 l'entreprise de biotechnologie HuidaGene Therapeutics \u00e0 Shanghai. 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