{"id":41599,"date":"2025-12-15T07:25:00","date_gmt":"2025-12-15T00:25:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=41599"},"modified":"2025-12-15T07:25:00","modified_gmt":"2025-12-15T00:25:00","slug":"patient-enrolment-completed-in-phase-2-agvhd-clinical-trial","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=41599","title":{"rendered":"Patient Enrolment Completed in Phase 2 aGvHD Clinical Trial"},"content":{"rendered":"<p><b>Announcement Highlights:<\/b><\/p>\n<ul type=\"disc\">\n<li><i>Patient\u00a0enrolment has been completed in Cynata&#8217;s Phase 2 clinical trial of <span class=\"xn-money\">CYP-001<\/span> in acute graft versus host disease<\/i><i>. <\/i><\/li>\n<li><i>The study has enrolled a total of 65 participants in the US, <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">Australia<\/span>, each of whom was\u00a0randomised to receive either steroids plus <span class=\"xn-money\">CYP-001<\/span>, or steroids plus placebo.<\/i><\/li>\n<li><i>Primary evaluation period expected to complete in <span class=\"xn-chron\">March 2026<\/span>, with results in <span class=\"xn-chron\">June 2026<\/span>.<\/i><\/li>\n<li><i><span class=\"xn-money\">CYP-001<\/span> has potential to address a major unmet need for the treatment of\u00a0aGvHD, a life-threatening condition.<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">MELBOURNE, Australia<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Dec. 15, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0<a href=\"https:\/\/cynata.com\/link\/egawbP\" target=\"_blank\" rel=\"nofollow\">Cynata Therapeutics Limited<\/a>\u00a0(ASX: <b>&#8220;CYP&#8221;<\/b> or <b>&#8220;Cynata&#8221;<\/b>), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that patient enrolment has been completed in its Phase 2 clinical trial of <span class=\"xn-money\">CYP-001<\/span> in adults with newly diagnosed, high risk acute graft versus host disease (aGvHD).<\/p>\n<p>A total of 65 participants have been enrolled in the trial across numerous clinical centres in the US, <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">Australia<\/span>. Each participant was randomised to receive either steroids plus <span class=\"xn-money\">CYP-001<\/span>, or steroids plus placebo.<\/p>\n<p>The trial involves a 100-day primary evaluation period, which is expected to conclude in <span class=\"xn-chron\">March 2026<\/span>, with results anticipated around <span class=\"xn-chron\">June 2026<\/span>. The primary endpoint is Overall Response Rate at Day 28.<\/p>\n<p><b>Dr <span class=\"xn-person\">Kilian Kelly<\/span>, Cynata&#8217;s Chief Executive Officer and Managing Director, said<\/b><i>: &#8220;We are delighted to complete patient enrolment in this trial, which has huge importance to Cynata, as well as to patients afflicted with aGvHD, an extremely debilitating and potentially life-threatening disorder. There remains a significant unmet need for safer and more effective treatments, given that existing treatments often fail to prevent poor outcomes, as well as potentially causing serious safety concerns. We are optimistic that the results of this trial will build on the very encouraging results we saw in Phase 1.&#8221; <\/i><\/p>\n<p><b>About aGvHD and <span class=\"xn-money\">CYP-001<\/span><\/b><\/p>\n<p>Acute graft versus host disease (aGvHD) is a serious and often life-threatening complication of bone marrow transplantation and similar procedures, where the donor&#8217;s immune cells (the graft) attack the recipient&#8217;s tissues (the host). aGvHD affects up to 50% of patients who receive transplants from other donors. Standard first-line treatment with steroids fails in around half of all aGvHD cases, which are known as &#8220;steroid-resistant&#8221; or SR\u2013aGvHD cases. Historical two-year survival rates in patients with SR\u2013aGvHD are less than 20%.<sup>[1]<\/sup><\/p>\n<p>Cynata&#8217;s Cymerus\u2122 iPSC<sup>[2]<\/sup>-derived MSC<sup>[3]<\/sup> \u00a0product for intravenous use, <span class=\"xn-money\">CYP-001<\/span>, is designed to modulate the immune system and improve both response rates and survival outcomes in aGvHD. In a successful Phase 1 trial in patients with SR\u2013aGvHD, 87% of patients showed an Overall Response, 53% showed a Complete Response, and 60% survived for at least two years. Importantly, there were no serious adverse events or safety concerns related to <span class=\"xn-money\">CYP-001<\/span> treatment. This ground-breaking trial led to two publications in the prestigious journal <i>Nature Medicine.<\/i><sup>[4],[5] <\/sup><span class=\"xn-money\">CYP-001<\/span> has been granted Orphan Drug Designation<sup>[6]<\/sup>\u00a0by the US FDA for the treatment of aGvHD.<\/p>\n<p>Investors are encouraged to visit the Company&#8217;s <a href=\"https:\/\/cynata.com\/link\/egawbP\" target=\"_blank\" rel=\"nofollow\">InvestorHub<\/a>, where they can view a video of Dr Kelly summarising this announcement.<\/p>\n<p class=\"prntac\"><b>-ENDS-<\/b><\/p>\n<p class=\"prntac\"><b>Authorised for release by Dr <span class=\"xn-person\">Kilian Kelly<\/span>, CEO &amp; Managing Director<\/b>\u00a0<\/p>\n<p><b>About Cynata Therapeutics (ASX: CYP) <\/b><\/p>\n<p>Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus\u2122, a proprietary therapeutic stem cell platform technology. Cymerus\u2122 overcomes the challenges and limitations of conventional MSC production by using induced pluripotent stem cells (iPSCs) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the necessity to obtain tissue from multiple donors on an ongoing basis, and without the complexity and product inconsistency resulting from conventional methods.<\/p>\n<p>Cynata has demonstrated positive safety and efficacy data for its Cymerus\u2122 product candidates <span class=\"xn-money\">CYP-001<\/span> and CYP\u2013006TK in Phase 1 clinical trials in steroid-resistant acute graft versus host disease (GvHD) and diabetic foot ulcers (DFU), respectively. Further clinical trials are now ongoing: a Phase 2 trial of <span class=\"xn-money\">CYP-001<\/span> in GvHD under a cleared US FDA IND; a Phase 1\/2 trial of CYP\u2013001 in patients undergoing kidney transplantation; and a Phase 3 trial of <span class=\"xn-money\">CYP-004<\/span> in osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus\u2122 technology in preclinical models of numerous other diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.<\/p>\n<p><b>Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, <\/b><a href=\"https:\/\/www.automicgroup.com.au\/\" target=\"_blank\" rel=\"nofollow\"><b>Automic Group<\/b><\/a><b>. <\/b>\u00a0<\/p>\n<p>[1]\u00a0Westin JR et al. Adv Hematol. 2011;2011:601953<\/p>\n<p>[2]\u00a0iPSC = induced pluripotent stem cell.<\/p>\n<p>[3]\u00a0MSC = mesenchymal stem (or stromal) cell.<\/p>\n<p>[4]\u00a0Bloor AJC, et al. Nat Med. 2020;26:1720\u20131725<\/p>\n<p>[5]\u00a0Kelly K, et al. Nat Med. 2024;30:1556\u20131558<\/p>\n<p>[6]\u00a0Orphan Drug Designation qualifies Cynata for incentives including extended marketing exclusivity, tax credits and fee waivers.<\/p>","protected":false},"excerpt":{"rendered":"<p><!-- wp:html --><\/p>\n<p><b>Announcement Highlights:<\/b><\/p>\n<ul type=\"disc\">\n<li><i>Patient\u00a0enrolment has been completed in Cynata&#8217;s Phase 2 clinical trial of <span class=\"xn-money\">CYP-001<\/span> in acute graft versus host disease<\/i><i>. <\/i><\/li>\n<li><i>The study has enrolled a total of 65 participants in the US, <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">Australia<\/span>, each of whom was\u00a0randomised to receive either steroids plus <span class=\"xn-money\">CYP-001<\/span>, or steroids plus placebo.<\/i><\/li>\n<li><i>Primary evaluation period expected to complete in <span class=\"xn-chron\">March 2026<\/span>, with results in <span class=\"xn-chron\">June 2026<\/span>.<\/i><\/li>\n<li><i><span class=\"xn-money\">CYP-001<\/span> has potential to address a major unmet need for the treatment of\u00a0aGvHD, a life-threatening condition.<\/i><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">MELBOURNE, Australia<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Dec. 15, 2025<\/span><\/span> \/PRNewswire\/ &#8212;\u00a0<a href=\"https:\/\/cynata.com\/link\/egawbP\" target=\"_blank\" rel=\"nofollow\">Cynata Therapeutics Limited<\/a>\u00a0(ASX: <b>&#8220;CYP&#8221;<\/b> or <b>&#8220;Cynata&#8221;<\/b>), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that patient enrolment has been completed in its Phase 2 clinical trial of <span class=\"xn-money\">CYP-001<\/span> in adults with newly diagnosed, high risk acute graft versus host disease (aGvHD).<\/p>\n<p>A total of 65 participants have been enrolled in the trial across numerous clinical centres in the US, <span class=\"xn-location\">Europe<\/span> and <span class=\"xn-location\">Australia<\/span>. Each participant was randomised to receive either steroids plus <span class=\"xn-money\">CYP-001<\/span>, or steroids plus placebo.<\/p>\n<p>The trial involves a 100-day primary evaluation period, which is expected to conclude in <span class=\"xn-chron\">March 2026<\/span>, with results anticipated around <span class=\"xn-chron\">June 2026<\/span>. The primary endpoint is Overall Response Rate at Day 28.<\/p>\n<p><b>Dr <span class=\"xn-person\">Kilian Kelly<\/span>, Cynata&#8217;s Chief Executive Officer and Managing Director, said<\/b><i>: &#8220;We are delighted to complete patient enrolment in this trial, which has huge importance to Cynata, as well as to patients afflicted with aGvHD, an extremely debilitating and potentially life-threatening disorder. There remains a significant unmet need for safer and more effective treatments, given that existing treatments often fail to prevent poor outcomes, as well as potentially causing serious safety concerns. We are optimistic that the results of this trial will build on the very encouraging results we saw in Phase 1.&#8221; <\/i><\/p>\n<p><b>About aGvHD and <span class=\"xn-money\">CYP-001<\/span><\/b><\/p>\n<p>Acute graft versus host disease (aGvHD) is a serious and often life-threatening complication of bone marrow transplantation and similar procedures, where the donor&#8217;s immune cells (the graft) attack the recipient&#8217;s tissues (the host). aGvHD affects up to 50% of patients who receive transplants from other donors. Standard first-line treatment with steroids fails in around half of all aGvHD cases, which are known as &#8220;steroid-resistant&#8221; or SR\u2013aGvHD cases. Historical two-year survival rates in patients with SR\u2013aGvHD are less than 20%.<sup>[1]<\/sup><\/p>\n<p>Cynata&#8217;s Cymerus\u2122 iPSC<sup>[2]<\/sup>-derived MSC<sup>[3]<\/sup> \u00a0product for intravenous use, <span class=\"xn-money\">CYP-001<\/span>, is designed to modulate the immune system and improve both response rates and survival outcomes in aGvHD. In a successful Phase 1 trial in patients with SR\u2013aGvHD, 87% of patients showed an Overall Response, 53% showed a Complete Response, and 60% survived for at least two years. Importantly, there were no serious adverse events or safety concerns related to <span class=\"xn-money\">CYP-001<\/span> treatment. This ground-breaking trial led to two publications in the prestigious journal <i>Nature Medicine.<\/i><sup>[4],[5] <\/sup><span class=\"xn-money\">CYP-001<\/span> has been granted Orphan Drug Designation<sup>[6]<\/sup>\u00a0by the US FDA for the treatment of aGvHD.<\/p>\n<p>Investors are encouraged to visit the Company&#8217;s <a href=\"https:\/\/cynata.com\/link\/egawbP\" target=\"_blank\" rel=\"nofollow\">InvestorHub<\/a>, where they can view a video of Dr Kelly summarising this announcement.<\/p>\n<p class=\"prntac\"><b>-ENDS-<\/b><\/p>\n<p class=\"prntac\"><b>Authorised for release by Dr <span class=\"xn-person\">Kilian Kelly<\/span>, CEO &amp; Managing Director<\/b>\u00a0<\/p>\n<p><b>About Cynata Therapeutics (ASX: CYP) <\/b><\/p>\n<p>Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus\u2122, a proprietary therapeutic stem cell platform technology. Cymerus\u2122 overcomes the challenges and limitations of conventional MSC production by using induced pluripotent stem cells (iPSCs) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the necessity to obtain tissue from multiple donors on an ongoing basis, and without the complexity and product inconsistency resulting from conventional methods.<\/p>\n<p>Cynata has demonstrated positive safety and efficacy data for its Cymerus\u2122 product candidates <span class=\"xn-money\">CYP-001<\/span> and CYP\u2013006TK in Phase 1 clinical trials in steroid-resistant acute graft versus host disease (GvHD) and diabetic foot ulcers (DFU), respectively. Further clinical trials are now ongoing: a Phase 2 trial of <span class=\"xn-money\">CYP-001<\/span> in GvHD under a cleared US FDA IND; a Phase 1\/2 trial of CYP\u2013001 in patients undergoing kidney transplantation; and a Phase 3 trial of <span class=\"xn-money\">CYP-004<\/span> in osteoarthritis. In addition, Cynata has demonstrated utility of its Cymerus\u2122 technology in preclinical models of numerous other diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.<\/p>\n<p><b>Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, <\/b><a href=\"https:\/\/www.automicgroup.com.au\/\" target=\"_blank\" rel=\"nofollow\"><b>Automic Group<\/b><\/a><b>. <\/b>\u00a0<\/p>\n<p>[1]\u00a0Westin JR et al. Adv Hematol. 2011;2011:601953<\/p>\n<p>[2]\u00a0iPSC = induced pluripotent stem cell.<\/p>\n<p>[3]\u00a0MSC = mesenchymal stem (or stromal) cell.<\/p>\n<p>[4]\u00a0Bloor AJC, et al. Nat Med. 2020;26:1720\u20131725<\/p>\n<p>[5]\u00a0Kelly K, et al. Nat Med. 2024;30:1556\u20131558<\/p>\n<p>[6]\u00a0Orphan Drug Designation qualifies Cynata for incentives including extended marketing exclusivity, tax credits and fee waivers.<\/p>\n<p><!-- \/wp:html --><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-41599","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/41599","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=41599"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/41599\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=41599"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=41599"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=41599"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}