{"id":12784,"date":"2021-11-05T09:00:00","date_gmt":"2021-11-05T13:00:00","guid":{"rendered":"https:\/\/wfh.org\/la-fda-dispuso-la-suspension-clinica-del-estudio-de-fase-3-de-terapia-genica-para-la-hemofilia-affine-de-pfizer-sangamo-therapeutics\/"},"modified":"2024-04-18T09:38:22","modified_gmt":"2024-04-18T13:38:22","slug":"la-fda-dispuso-la-suspension-clinica-del-estudio-de-fase-3-de-terapia-genica-para-la-hemofilia-affine-de-pfizer-sangamo-therapeutics","status":"publish","type":"post","link":"https:\/\/wfh.org\/es\/article\/la-fda-dispuso-la-suspension-clinica-del-estudio-de-fase-3-de-terapia-genica-para-la-hemofilia-affine-de-pfizer-sangamo-therapeutics\/","title":{"rendered":"La FDA dispuso la suspensi\u00f3n cl\u00ednica del estudio de fase 3 de terapia g\u00e9nica para la hemofilia, AFFINE, de Pfizer\/Sangamo Therapeutics"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"12784\" class=\"elementor elementor-12784 elementor-1290\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a0ca0d0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a0ca0d0\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6f4a947\" data-id=\"6f4a947\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-fcd217e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"fcd217e\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-3ddf5f4\" data-id=\"3ddf5f4\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d08b0a2 elementor-widget elementor-widget-image\" data-id=\"d08b0a2\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 25-07-2024 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"620\" height=\"400\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/WFH-international-logo-620x400-1.gif\" class=\"attachment-large size-large wp-image-1335\" alt=\"\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-85a308d\" data-id=\"85a308d\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9e02d19 elementor-widget elementor-widget-image\" data-id=\"9e02d19\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"620\" height=\"400\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/NHF-logo-620x400-1.jpg\" class=\"attachment-large size-large wp-image-1338\" alt=\"\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/NHF-logo-620x400-1.jpg 620w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/NHF-logo-620x400-1-300x194.jpg 300w\" sizes=\"(max-width: 620px) 100vw, 620px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-39a7f04\" data-id=\"39a7f04\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e702128 elementor-widget elementor-widget-image\" data-id=\"e702128\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"620\" height=\"400\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/EHC_620x400.png\" class=\"attachment-large size-large wp-image-1341\" alt=\"\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/EHC_620x400.png 620w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/11\/EHC_620x400-300x194.png 300w\" sizes=\"(max-width: 620px) 100vw, 620px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-b049c4b elementor-widget elementor-widget-text-editor\" data-id=\"b049c4b\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 25-07-2024 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>El mi\u00e9rcoles 3 de noviembre, la Administraci\u00f3n de Alimentos y Medicamentos de Estados Unidos (FDA por su sigla en ingl\u00e9s) dispuso la suspensi\u00f3n cl\u00ednica del programa de terapia g\u00e9nica para la hemofilia A de Pfizer\/Sangamo, inclusive del transcendental estudio de fase 3, AFFINE (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04370054\" target=\"_blank\" rel=\"noopener noreferrer\">NCT04370054<\/a>), con el f\u00e1rmaco giroctocogene fitelparvovec (SB-525 o PF-07055480), hasta completar la revisi\u00f3n de una propuesta de enmienda al protocolo. (<a href=\"https:\/\/investor.sangamo.com\/news-releases\/news-release-details\/sangamo-therapeutics-reports-recent-business-and-clinical\" target=\"_blank\" rel=\"noopener noreferrer\">Comunicado de prensa de Sangamo, en ingl\u00e9s<\/a>). Esta decisi\u00f3n se tom\u00f3 despu\u00e9s de que Pfizer suspendiera el estudio e hiciera p\u00fablico este hecho el 2 de noviembre de 2021.<\/p>\n<p>El prop\u00f3sito de la suspensi\u00f3n cl\u00ednica es permitir la implementaci\u00f3n de una enmienda al protocolo luego de observar niveles de factor VIII mayores a 150% en algunos de los participantes en el ensayo. El objetivo de la enmienda al protocolo es proporcionar directrices para el tratamiento m\u00e9dico de niveles de factor VIII elevados.<\/p>\n<p>Es de esperarse que el ensayo AFFINE cuente con un total de aproximadamente 50 participantes. M\u00e1s del 50% de los participantes en el ensayo ha recibido su dosis de giroctocogene fitelparvovec. Hasta ahora, ninguno de los participantes que ha recibido esta terapia g\u00e9nica ha presentado un evento tromb\u00f3tico, y algunos participantes est\u00e1n recibiendo tratamiento con anticoagulantes orales para reducir el riesgo de trombosis.<\/p>\n<p>Como siguiente etapa, los encargados de la reglamentaci\u00f3n evaluar\u00e1n la enmienda al protocolo y cualquier reinicio de dosificaciones adicionales.<\/p>\n<p>En otro asunto no relacionado con la pausa del programa de terapia g\u00e9nica para la hemofilia A, Pfizer y la FDA decidieron no realizar un an\u00e1lisis interino de dos ensayos de terapia g\u00e9nica para la hemofilia, en vez de lo cual planean esperar los an\u00e1lisis completos de 50 o m\u00e1s participantes en el ensayo para la hemofilia A y de 40 participantes en el ensayo para la hemofilia B. Esta decisi\u00f3n retrasar\u00e1 la lectura final de los datos de estos dos ensayos.<\/p>\n<p>Estamos reportando esta informaci\u00f3n, que es de dominio p\u00fablico, y continuaremos manteniendo a nuestras comunidades de pacientes informadas sobre cualesquiera otras novedades relevantes. Si tuviera cualquier pregunta comun\u00edquese con su m\u00e9dico tratante y con su centro de tratamiento de hemofilia.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a577110 elementor-widget elementor-widget-heading\" data-id=\"a577110\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.23.0 - 25-07-2024 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h3 class=\"elementor-heading-title elementor-size-default\">Acerca del estudio AFFINE<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12ac5bc elementor-widget elementor-widget-text-editor\" data-id=\"12ac5bc\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>El estudio de fase 3 AFFINE (<em>efficAcy and saFety Factor vIii geNe thErapy in haemophilia A patients<\/em>; NCT04370054) es un estudio multic\u00e9ntrico, de brazo \u00fanico, con etiqueta a la vista, cuyo objetivo es evaluar la eficacia y seguridad de una infusi\u00f3n \u00fanica de giroctocogene fitelparvovec en m\u00e1s de 50 participantes varones adultos (de entre 18 y 64 a\u00f1os), con hemofilia A de moderadamente grave a grave.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3d24f70 elementor-widget elementor-widget-heading\" data-id=\"3d24f70\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Acerca del giroctocogene fitelparvovec<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe3c1d3 elementor-widget elementor-widget-text-editor\" data-id=\"fe3c1d3\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>El giroctocogene fitelparvovec (SB-525 o PF-07055480) comprende un vector viral adenoasociado recombinante de serotipo 6 (AAV2\/6) que codifica el \u00e1cido desoxirribonucleico complementario para el FVIII humano con dominio B borrado. El casete de expresi\u00f3n del giroctocogene fitelparvovec se dise\u00f1\u00f3 para una expresi\u00f3n ideal espec\u00edficamente hep\u00e1tica de la prote\u00edna del FVIII y apoya la producci\u00f3n de altos rendimientos del vector. El casete transcriptor del giroctocogene fitelparvovec incorpora modificaciones multifactoriales al m\u00f3dulo promotor espec\u00edficamente hep\u00e1tico, al transgene del FVIII, a la se\u00f1al de poliadenilaci\u00f3n sint\u00e9tica, y a la secuencia principal del vector.<\/p>\n<p>Modificado el 9 de noviembre de 2021.<\/p>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-763cdb1 elementor-widget elementor-widget-text-editor\" data-id=\"763cdb1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Fuentes:<\/p>\n<ol>\n<li><a href=\"https:\/\/www.ehc.eu\/pfizer-hemophilia-a-clinical-program-update_november-5th-2021\/\" target=\"_blank\" rel=\"noopener noreferrer\">Comunicado de Pfizer (en ingl\u00e9s)<\/a>:\u00a0<em>Pfizer giroctocogene fitelparvovec (Hemophilia A gene therapy) AFFINE Phase 3 Study Update<\/em>, 5 de noviembre de 2021.<\/li>\n<li>Comunicado de prensa de Sangamo Therapeutics:<em>\u00a0Sangamo Therapeutics Reports Recent Business and Clinical Highlights and Third Quarter 2021 Financial Results<\/em>, 4\u00a0de\u00a0noviembre de 2021 (<a href=\"https:\/\/investor.sangamo.com\/news-releases\/news-release-details\/sangamo-therapeutics-reports-recent-business-and-clinical\" target=\"_blank\" rel=\"noopener noreferrer\">texto en ingl\u00e9s del comunicado<\/a>).<\/li>\n<\/ol>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>El mi\u00e9rcoles 3 de noviembre, la Administraci\u00f3n de Alimentos y Medicamentos de Estados Unidos (FDA por su sigla en ingl\u00e9s) dispuso la suspensi\u00f3n cl\u00ednica del programa de terapia g\u00e9nica para la hemofilia A de Pfizer\/Sangamo, inclusive del transcendental estudio de fase 3, AFFINE (NCT04370054), con el f\u00e1rmaco giroctocogene fitelparvovec (SB-525 o PF-07055480), hasta completar la revisi\u00f3n de una propuesta de enmienda al protocolo.<\/p>\n","protected":false},"author":3,"featured_media":19564,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[121,192,232,196,231],"tags":[],"search-category":[320],"class_list":["post-12784","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-declaraciones-y-notificaciones-de-la-fmh","category-eventos","category-gtrt-es","category-noticias-medicas","category-gene-therapy-es","search-category-article-es"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.4 (Yoast SEO v23.4) - 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