{"id":4571,"date":"2024-01-18T00:54:45","date_gmt":"2024-01-18T00:54:45","guid":{"rendered":"https:\/\/economicherald.net\/?p=4571"},"modified":"2024-01-18T00:54:45","modified_gmt":"2024-01-18T00:54:45","slug":"asx-health-stocks-amplia-gets-fda-green-light-to-commence-trial-recce-study-meets-all-primary-endpoints","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=4571","title":{"rendered":"ASX Health Stocks: Amplia gets FDA green light to commence trial; Recce study meets all primary endpoints"},"content":{"rendered":"<p>Recce Pharma says study met all all primary endpoints<br \/>\nAmplia gets US FDA IND clearance to commence new pancreatic cancer trial<br \/>\nImricor also gets approval to start VISABL-AFL clinical trial<\/p>\n<p>\u00a0<\/p>\n<h2>Recce\u2019s clinical trial meets all primary endpoints<\/h2>\n<p><strong><a href=\"https:\/\/stockhead.com.au\/company\/recce-pharmaceuticals-rce\/\">Recce Pharmaceuticals (ASX:RCE)<\/a><\/strong> rose 10% this morning on an update on its Phase I\/II diabetic foot infection clinical trial.<\/p>\n<p>The trial assessed the safety and efficacy of RECCE 327 (R327), a broad-spectrum anti-infective, given as a topical treatment on patients with mild skin and soft tissue diabetic foot infections (DFI).<\/p>\n<p>Recce said the study met all primary endpoints, with R327 well-tolerated, and all patients with DFI had their infections resolved or cured following a daily or every second day dosage for 14 days.<\/p>\n<p>Following this success, Recce says it will look to expand clinical sites domestically and internationally, in the interest of accessing a greater patient population.<\/p>\n<p>\u201cWe are pleased that the Phase I\/II clinical trial has met all primary endpoints, and produced efficacy data to support R327 to be used as topical agent,\u201d said Recce Pharma\u2019s CEO, James Graham.<\/p>\n<p>\u201cWe look forward to expanding the study by accessing a global patient population and further enhancing our portfolio of human efficacy data.\u201d<\/p>\n<p>\u00a0<\/p>\n<h2>Amplia gets US FDA clearance to commence new trial<\/h2>\n<p><strong><a href=\"https:\/\/stockhead.com.au\/company\/amplia-atx\/\">Amplia Therapeutics (ASX:ATX)<\/a><\/strong> says the<strong> US FDA<\/strong> has cleared its<strong> Investigational New Drug (IND) Application<\/strong> for a clinical trial of <strong>narmafotinib<\/strong> in the US.<\/p>\n<p>The trial will explore the combination of narmafotinib and <em><strong>FOLFIRINOX<\/strong>,<\/em> in advanced pancreatic cancer patients.<\/p>\n<p>The company is currently undertaking a Phase 2a clinical trial of narmafotinib, in combination with two chemotherapy drugs, g<em>emcitabine<\/em> and <em>Abraxane,<\/em> in advanced pancreatic patients in Australia and South Korea.<\/p>\n<p>In contrast, the IND application reviewed by the FDA today supports the use of narmafotinib in combination with a different chemotherapy called FOLFIRINOX (a four drug regimen), which is widely employed in the US for the treatment of pancreatic cancer.<\/p>\n<p>\u201cClearance of the IND by the US FDA is a significant step forward for the company,\u201d says Amplia\u2019s CEO, <strong>Dr Chris Burns<\/strong>.<\/p>\n<p>\u201cWe will now start planning the combination trial of narmafotinib with FOLFIRINOX in the US, which expands the clinical opportunities for our best-in-class FAK inhibitor.\u201d<\/p>\n<p>\u201cFOLFIRINOX is the preferred treatment for pancreatic patients in the US and most of Europe.<\/p>\n<p>\u201cTherefore this combination trial is highly relevant as we position narmafotinib as the preferred drug to enhance the effectiveness of existing chemotherapy combinations in pancreatic cancer,\u201d said Ward.<\/p>\n<p>\u00a0<\/p>\n<h2>Imricor VISABL-AFL clinical trial to start soon<\/h2>\n<p>Meanwhile, <strong><a href=\"https:\/\/stockhead.com.au\/company\/imricor-medical-systems-imr\/\">Imricor Medical Systems (ASX:IMR)<\/a><\/strong> announced that the <strong>VISABL-AFL clinical trial<\/strong> has been approved by <strong>Johns Hopkins Hospital\u2019s Institutional Review Board (IRB)<\/strong>.<\/p>\n<p>The first enrolment for the trial is now expected within the next few weeks.<\/p>\n<p>VISABL-AFL is the clinical trial supporting US FDA approval of Imricor\u2019s products.<\/p>\n<p>Imricor\u2019s Chair and CEO,<strong> Steve Wedan<\/strong>, said the John Hopkins approval is a major milestone in the company\u2019s FDA approval process.<\/p>\n<p>\u201cAs a company, we are pleased that the work that we have quietly gone about over the past 12- 18 months is enabling us to start the year with strong momentum.<\/p>\n<p>\u201cLast week, we secured Saudi FDA approval, and now we have Johns Hopkins IRB approval. Things are coming into place nicely, and we have many more great milestones ahead of us,\u201d said Wedan.<\/p>\n<p>The VISABL-AFL clinical trial will study ablation procedures performed with the IMR\u2019s Vision-MR Ablation Catheter (second generation), HAT 500 RF generator, and irrigation pump.<\/p>\n<p>The study will include sites in the US and Europe.<\/p>\n<h2>Share prices today:<\/h2>\n\n<p><span class=\"mce_SELRES_start\">\ufeff<\/span><span class=\"mce_SELRES_start\"><\/span>\u00a0<br \/>\n<span class=\"et_bloom_bottom_trigger\"><\/span><\/p>\n<p>The post <a href=\"https:\/\/stockhead.com.au\/health\/asx-health-stocks-amplia-gets-fda-green-light-to-commence-trial-recce-study-meets-all-primary-endpoints\/\">ASX Health Stocks: Amplia gets FDA green light to commence trial; Recce study meets all primary endpoints<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Recce Pharma says study met all all primary endpoints Amplia gets US FDA IND clearance to commence new pancreatic cancer trial Imricor also gets approval <a href=\"https:\/\/economicherald.net\/?p=4571\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":4572,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-4571","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 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ASX Health Stocks: Amplia gets FDA green light to commence trial; 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