{"id":976557,"date":"2026-06-29T10:57:40","date_gmt":"2026-06-29T14:57:40","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/"},"modified":"2026-06-29T10:57:40","modified_gmt":"2026-06-29T14:57:40","slug":"approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/","title":{"rendered":"Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress"},"content":{"rendered":"<div class=\"mw_release\">\n<p>June 29, 2026<\/p>\n<p align=\"center\">\n        <b>Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP<\/b><br \/>\n        <br \/>\n        <b>and<\/b><br \/>\n        <br \/>\n        <b>Update on Serenta Progress<\/b>\n      <\/p>\n<p align=\"justify\">Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (\u201cBiodexa\u201d or \u201cthe Company\u201d), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has received approval from Health Canada to expand its registrational Phase 3 trial in familial adenomatous polyposis (\u201cFAP\u201d) into Canada.<\/p>\n<p align=\"justify\">The Phase 3 study, branded Serenta, is already up and running in a total of 29 active recruiting clinical centers spread across the US and five countries in Europe. Canada is expected to add a further three or four new centers.<\/p>\n<p align=\"justify\">The Serenta trial is expected to enrol 168 patients. As of today, 73 patients have been enrolled.<\/p>\n<p align=\"justify\">Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said \u201c<i>We have seen an acceleration in enrolment in the last few months as the European centers have opened. The addition of Canada underpins our enrolment goals. Serenta has been received positively by clinicians and FAP patients for whom there is currently no approved therapeutic option and life-altering surgery remains standard of care.\u201d<\/i><\/p>\n<p>\n        <b>About Familial Adenomatous Polyposis<\/b>\n      <\/p>\n<p align=\"justify\">FAP is characterized as a proliferation of polyps in the colon and\/or rectum, usually occurring in mid-teens. There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and\/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and\/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps \u2013 thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.<\/p>\n<p align=\"justify\">\n        <b>About eRapa<\/b><br \/>\n        <br \/>eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Importantly, mTOR has been shown to be over-expressed in FAP polyps \u2013 thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial which is planned to initiate 30 clinical sites across the US and Europe and to enrol 168 patients randomized 2:1, drug: placebo. The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas.<\/p>\n<p align=\"justify\">\n        <b>The Cancer Prevention and Research Institute of Texas<\/b><br \/>\n        <br \/>To date, CPRIT has awarded\u00a0$2.9 billion\u00a0in grants to\u00a0Texas\u00a0research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 237 distinguished researchers, supported the establishment, expansion or relocation of 43 companies to\u00a0Texas\u00a0and generated over\u00a0$5.7 billion\u00a0in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.4 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On\u00a0November 5, 2019,\u00a0Texas\u00a0voters overwhelmingly approved a constitutional amendment to provide an additional\u00a0$3 billion\u00a0to CPRIT for a total\u00a0$6 billion\u00a0investment in cancer research and prevention. Learn more at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=c9KV3cPtytSlvCLt4KDOdfGvnKHVWeGSC-G0PIgR4sgvMVYMondBRWCSp3oI4LdSOgOj_S6QZldKNxGPeadHTRIdcRIH5x_eMoPe_Y4GtGk=\" rel=\"nofollow\" target=\"_blank\">https:\/\/cprit.texas.gov\/<\/a>.<\/p>\n<p>\n        <b>About Biodexa Pharmaceuticals PLC<\/b>\n      <\/p>\n<p align=\"justify\">The Company\u2019s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, MTX240 under development for Gastrointestinal Stromal Tumors (GIST) and tolimidone, under development for the treatment of type 1 diabetes.<\/p>\n<p align=\"justify\">eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (<u>m<\/u>ammalian <u>T<\/u>arget <u>O<\/u>f <u>R<\/u>apamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis.<\/p>\n<p align=\"justify\">MTX240 is a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signalling.<\/p>\n<p align=\"justify\">Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycaemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.<\/p>\n<p align=\"justify\">Biodexa\u2019s headquarters and R&amp;D facility is in Cardiff, UK. For more information visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=GLsCZyPKL4n_erUz0NNi4x4ohN3wqTdC4BNJMkVtmYTRjWxhwAdcq7G8FviROlc5nSPCF1ilGaxu2YQ4m7CXNbKOSbgH8Cln5PwhorKInNQ=\" rel=\"nofollow\" target=\"_blank\">www.biodexapharma.com<\/a>.<\/p>\n<p align=\"justify\">\n        <b>For more company information, please contact:<\/b>\n      <\/p>\n<p align=\"justify\">Stephen Stamp, CEO<br \/>Tel: +44 (0)29 20480 180<br \/>www.biodexapharma.com<\/p>\n<p><b>For information on the Company\u2019s Early Access Program for eRapa, please contact <\/b><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=qjQt6OTyy08VT4s15xRqXpgJyo4DVQCkW4i-m2jK1c4bv9XewPvcQaLnD6V7xs_Nt-4pJHqidYdB4xW0cVZBBi3weIGKi1Gp8Lxr2UKthbh2O8VfxeZRDvYB-kIcw8fw\" rel=\"nofollow\" target=\"_blank\"><b>erapa@tannerpharma.com<\/b><\/a><\/p>\n<p align=\"justify\">\n        <b>Forward-Looking Statements<\/b><br \/>\n        <br \/>Certain statements in this announcement may constitute \u201cforward-looking statements\u201d within the meaning of legislation in the United Kingdom and\/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management\u2019s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as \u201cplans\u201d, \u201cexpects\u201d or \u201cdoes not anticipate\u201d, or \u201cbelieves\u201d, or variations of such words and phrases or statements that certain actions, events or results \u201cmay\u201d, \u201ccould\u201d, \u201cwould\u201d, \u201cmight\u201d or \u201cwill be taken\u201d, \u201coccur\u201d or \u201cbe achieved.\u201d Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict,<\/p>\n<p align=\"justify\">that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.<\/p>\n<p align=\"justify\">Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMTIwOTg3NiM0MDI0MzUxODYjMjI1OTMzMA==\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml-eu.globenewswire.com\/media\/ZDM5NmRmNzMtYzM4Ni00Yjg5LTgyNjktNTBhOWY3NDIxM2JkLTEyNzA4ODAtMjAyNi0wNi0yOS1lbg==\/tiny\/Biodexa-Pharmaceuticals-PLC.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>June 29, 2026 Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (\u201cBiodexa\u201d or \u201cthe Company\u201d), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has received approval from Health Canada to expand its registrational Phase 3 trial in familial adenomatous polyposis (\u201cFAP\u201d) into Canada. The Phase 3 study, branded Serenta, is already up and running in a total of 29 active recruiting clinical centers spread across the US and five countries in Europe. Canada is expected to add a further three or four new centers. The Serenta trial is expected to &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-976557","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress - Market Newsdesk<\/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.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"June 29, 2026 Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (\u201cBiodexa\u201d or \u201cthe Company\u201d), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has received approval from Health Canada to expand its registrational Phase 3 trial in familial adenomatous polyposis (\u201cFAP\u201d) into Canada. The Phase 3 study, branded Serenta, is already up and running in a total of 29 active recruiting clinical centers spread across the US and five countries in Europe. Canada is expected to add a further three or four new centers. The Serenta trial is expected to &hellip; Continue reading &quot;Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-29T14:57:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMTIwOTg3NiM0MDI0MzUxODYjMjI1OTMzMA==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress\",\"datePublished\":\"2026-06-29T14:57:40+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\\\/\"},\"wordCount\":1150,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=MTAwMTIwOTg3NiM0MDI0MzUxODYjMjI1OTMzMA==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\\\/\",\"name\":\"Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/","og_locale":"en_US","og_type":"article","og_title":"Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress - Market Newsdesk","og_description":"June 29, 2026 Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (\u201cBiodexa\u201d or \u201cthe Company\u201d), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has received approval from Health Canada to expand its registrational Phase 3 trial in familial adenomatous polyposis (\u201cFAP\u201d) into Canada. The Phase 3 study, branded Serenta, is already up and running in a total of 29 active recruiting clinical centers spread across the US and five countries in Europe. Canada is expected to add a further three or four new centers. The Serenta trial is expected to &hellip; Continue reading \"Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/","og_site_name":"Market Newsdesk","article_published_time":"2026-06-29T14:57:40+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMTIwOTg3NiM0MDI0MzUxODYjMjI1OTMzMA==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress","datePublished":"2026-06-29T14:57:40+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/"},"wordCount":1150,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=MTAwMTIwOTg3NiM0MDI0MzUxODYjMjI1OTMzMA==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/approval-from-health-canada-to-expand-serenta-registrational-phase-3-trial-in-fap-and-update-on-serenta-progress\/","name":"Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress - 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