{"id":15752,"date":"2019-10-14T16:29:32","date_gmt":"2019-10-14T14:29:32","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=15752"},"modified":"2019-10-22T16:34:17","modified_gmt":"2019-10-22T14:34:17","slug":"xenikos-receives-fda-fast-track-designation","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/xenikos-receives-fda-fast-track-designation\/","title":{"rendered":"Xenikos receives FDA Fast Track designation"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Xenikos, which develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to T-Guard, Xenikos\u2019 flagship product designed to treat steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients following allogeneic stem cell transplantation. Xenikos is currently preparing to initiate a U.S. pivotal Phase 3 trial with T-Guard.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Fast Track program is designed to facilitate the development of new therapies for treating severe medical conditions in order to fill a currently unmet medical need. Fast Track designation allows for early and frequent communications with the FDA, as well as rolling submission of the market application.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201cWe are delighted that the FDA has given Fast Track designation to T-Guard, as this will support our goal of getting T-Guard to patients as quickly as possible,\u201d said Dr. Ypke van Oosterhout, Chief Executive Officer of Xenikos. \u201cWe\u2019re also looking forward to starting our Phase 3 pivotal trial in the U.S. Effective new therapies for treating SR-aGVHD are urgently needed, and we believe that T-Guard, which can rapidly and safely reset the patient\u2019s immune system, has the potential to provide an important new treatment option to patients with this devastating, potentially fatal condition.\u201d<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>T-Guard: Helping reset the body\u2019s immune system<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">T-Guard is designed to safely and swiftly reset the body\u2019s immune system in life-threatening T cell\u2012mediated conditions, including transplant-related rejection, acute solid-organ rejection, and severe autoimmune disease. T Guard consists of a unique combination of toxin-conjugated monoclonal antibodies that target CD3 and CD7 molecules on T cells and NK cells. Preclinical and early clinical testing have shown that T-Guard can specifically identify and eliminate mature T cells and NK cells with minimal treatment-related side effects. Importantly, T-Guard\u2019s action is short-lived, thereby significantly reducing the patient\u2019s vulnerability to opportunistic infections compared to currently available therapies. Xenikos successfully completed a Phase 1\/2 study for the second-line treatment of SR-aGVHD in patients following hematopoietic stem cell transplantation (HSCT). The results of this study showed that just one week of T-Guard treatment triggered a strong clinical response and doubled the 6-month overall survival rate. These results were published in the peer-reviewed journal&nbsp;<a href=\"https:\/\/www.bbmt.org\/article\/S1083-8791(18)30691-8\/fulltext\">Biology of Blood and Marrow Transplantation<\/a>. A U.S. Phase 3 registration trial involving patients with SR-aGVHD following allogeneic stem cell transplantation will begin soon, and T-Guard has been granted Fast Track designation by the FDA, as well as Orphan Drug Designation status in both the EU and the U.S. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Source: <a href=\"https:\/\/www.xenikos.com\/xenikos-receives-fda-fast-track-designation-for-t-guard\/\"><strong>Xenikos<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Xenikos, which develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to T-Guard, Xenikos\u2019 flagship product designed to treat steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients following allogeneic stem cell transplantation. Xenikos is currently preparing to [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-15752","post","type-post","status-publish","format-standard","hentry","category-gezondheid"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Xenikos receives FDA Fast Track designation - hollandbio<\/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.hollandbio.nl\/en\/nieuws\/xenikos-receives-fda-fast-track-designation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Xenikos receives FDA Fast Track designation - hollandbio\" \/>\n<meta property=\"og:description\" content=\"Xenikos, which develops innovative immunotherapies for treating patients with severe immune disease and post-transplant rejection, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to T-Guard, Xenikos\u2019 flagship product designed to treat steroid-refractory acute graft-versus-host disease (SR-aGVHD) in patients following allogeneic stem cell transplantation. 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