{"id":3187,"date":"2023-12-13T23:39:55","date_gmt":"2023-12-13T23:39:55","guid":{"rendered":"https:\/\/economicherald.net\/?p=3187"},"modified":"2023-12-13T23:39:55","modified_gmt":"2023-12-13T23:39:55","slug":"argenica-on-track-to-commence-patient-dosing-for-phase-2-stroke-clinical-trial-in-q1","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=3187","title":{"rendered":"Argenica on track to commence patient dosing for Phase 2 stroke clinical trial in Q1"},"content":{"rendered":"<p>Argenica Therapeutics wraps up manufacturing of ARG-007 drug for Phase 2 clinical trial in acute ischaemic stroke<br \/>\nPatient dosing for trial expected to commence in Q1 CY2024<br \/>\nData on safety and efficacy will pave the way for Phase 3 trial<\/p>\n<p>\u00a0<\/p>\n<p><strong><em>Special Report:<\/em> Argenica Therapeutics is progressing its <\/strong><strong>Phase 2 clinical trial in acute ischaemic stroke (AIS) patients, with the manufacturing of its ARG-007 drug substance now complete.<\/strong><\/p>\n<p>The Phase 2 trial will be a multi-centre, double-blind, randomised, placebo-controlled, parallel-group, single-dose study to determine the safety, preliminary efficacy and pharmacokinetics of ARG-007 in AIS patients.<\/p>\n<p>Proving the drug is safe is expected to pave the way for <a href=\"https:\/\/stockhead.com.au\/company\/argenica-therapeutics-agn\/\"><strong>Argenica Therapeutics (ASX:AGN)<\/strong><\/a> to progress to a pivotal Phase 3 trial and engage with global pharmaceutical companies.<\/p>\n<p>The trial will recruit only patients with a diagnosed large vessel occlusion (LVO) stroke that are eligible for endovascular thrombectomy (mechanical removal of a clot in the brain).<\/p>\n<p>LVO strokes account for close to 40% of all acute ischaemic strokes and are responsible for 60% of post-stroke dependency and 90% of mortalities after stroke \u2013 and are therefore considered the most devastating type of stroke.<\/p>\n<p>Generating preliminary data on the ability of ARG-007 to reduce brain tissue death following stroke and thrombectomy will be a significant de-risking milestone for the company.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<h2><strong>Patient dosing in Q1 CY24<\/strong><\/h2>\n<p>The finalised sterile drug product manufacturing is now expected to be completed by the end of Q4 2023 ahead of patient dosing in Q1 2024.<\/p>\n<p>\u201cProving the scale-up manufacturing of the clinical grade ARG-007 drug product is a significant milestone for the company, and we are delighted manufacturing timelines remain on track,\u201d managing director Dr Liz Dallimore said.<\/p>\n<p>\u201cFurther, we are pleased with the progress of research governance at each hospital, there is a lot of work going on behind the scenes in the company to prepare for our upcoming Phase 2 trial.<\/p>\n<p>\u201cWe look forward to keeping shareholders updated as further milestones are achieved.\u201d<\/p>\n<p>The trial will be conducted in up to 10 hospitals across Australia that have dedicated stroke care units capable of performing endovascular thrombectomy.<\/p>\n<p>Final approvals for hospital clinical trial sites remains on-track, with one hospital ready to commence patient dosing, and several others in the final stages of approval.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<h2><strong>Data will pave the way for Phase 3<\/strong><\/h2>\n<p>The Phase 2 trial will provide data on the safety and preliminary efficacy of ARG-007 in acute ischaemic stroke patients, paving the way for a pivotal Phase 3 trial and potential partnering with pharmaceutical companies.<\/p>\n<p>As part of the trial, AGN has established an independent Data Safety Monitoring Board (DSMB) comprising several independent neurologists and a biostatistician, who will be responsible for reviewing the safety data as the trial progresses.<\/p>\n<p>The purpose of the DSMB is to monitor the rates of adverse events (AEs), endpoints, and study progress in the Phase 2 trial.<\/p>\n<p>In addition, the DSMB will provide recommendations regarding the continuation, modification, or termination of the study to AGN.<\/p>\n<p>\u00a0<\/p>\n\n<p><span class=\"mce_SELRES_start\">\ufeff<\/span>\u00a0<\/p>\n<p><em>This article was developed in collaboration with Argenica Therapeutics, a Stockhead advertiser at the time of publishing. <\/em><\/p>\n<p><em>\u00a0<\/em><\/p>\n<p><em>This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n<p><span class=\"et_bloom_bottom_trigger\"><\/span><\/p>\n<p>The post <a href=\"https:\/\/stockhead.com.au\/health\/argenica-on-track-to-commence-patient-dosing-for-phase-2-stroke-clinical-trial-in-q1\/\">Argenica on track to commence patient dosing for Phase 2 stroke clinical trial in Q1<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Argenica Therapeutics wraps up manufacturing of ARG-007 drug for Phase 2 clinical trial in acute ischaemic stroke Patient dosing for trial expected to commence in <a href=\"https:\/\/economicherald.net\/?p=3187\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":3188,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-3187","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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