[{"id":4704,"date":"2019-05-07T11:36:14","date_gmt":"2019-05-07T09:36:14","guid":{"rendered":"https:\/\/www.egetis.com\/?p=4704"},"modified":"2019-05-07T11:40:07","modified_gmt":"2019-05-07T09:40:07","slug":"intervju-med-nicklas-westerholm-om-forsta-delarsrapporten-for-2019","status":"publish","type":"post","link":"https:\/\/www.egetis.com\/sv\/intervju-med-nicklas-westerholm-om-forsta-delarsrapporten-for-2019\/","title":{"rendered":"Intervju med Nicklas Westerholm om f\u00f6rsta del\u00e5rsrapporten f\u00f6r 2019"},"content":{"rendered":"<hr \/>\n<p><a href=\"https:\/\/redeye.solidtango.com\/widgets\/embed\/5h1pe17k?auto_play=true\" target=\"_blank\" rel=\"noopener noreferrer\">L\u00e4nk till Redeye-intervjun med PledPharmas vd Nicklas Westerholm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u00e4nk till Redeye-intervjun med PledPharmas vd Nicklas Westerholm<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[41],"tags":[],"class_list":["post-4704","post","type-post","status-publish","format-standard","hentry","category-icke-regulatoriskt"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - 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Bolaget arrangerar idag en kapitalmarknadsdag f\u00f6r investerare, analytiker och media i Stockholm, Sverige.<\/p>\n<p>PledPharmas ledningsgrupp samt tv\u00e5 key opinion leaders (KOL) kommer att presentera utvecklingsprogrammen PledOx\u00ae och Aladote\u00ae. Bredare information kring \u201dunmet medical need\u201d, detaljer kring utvecklingsprogrammen, den kommersiella potentialen inklusive m\u00f6jligheter till indikationsutvidgning f\u00f6r PledOx\u00ae kommer att presenteras.<\/p>\n<p>Presentat\u00f6rer \u00e4r H\u00e5kan \u00c5str\u00f6m, styrelseordf\u00f6rande, Nicklas Westerholm, vd, samt \u00f6vriga medlemmar fr\u00e5n ledningsgruppen. \u00c4ven tv\u00e5 KOLs, dr. James Dear, Edinburgh University och prof. Per Pfeiffer, Odense University kommer att presentera. Eventet kommer modereras av Lars Hevreng, analyschef p\u00e5 Vator Securities och tidigare healthcare analytiker.<\/p>\n<p><strong>Detaljer om eventet:<\/strong><\/p>\n<p>Tid: 10:00-15:00 CET<\/p>\n<p>Plats: Redeye, M\u00e4ster Samuelsgatan 42, v\u00e5n 10, Stockholm<\/p>\n<p>Presentationerna kommer att h\u00e5llas p\u00e5 engelska.<\/p>\n<p>Kapitalmarknadsdagen kommer att lives\u00e4ndas p\u00e5 <a href=\"http:\/\/www.redeye.se\/live\/pled-kapitalmarknadsdag-2019\">www.redeye.se\/live\/pled-kapitalmarknadsdag-2019<\/a><\/p>\n<p>F\u00f6r ytterligare information, kontakta:<\/p>\n<p>Nicklas Westerholm, Verkst\u00e4llande direkt\u00f6r<br \/>\nTel. 073 354 20 62<br \/>\n<a href=\"mailto:nicklas.westerholm@pledpharma.se\">nicklas.westerholm@pledpharma.se<\/a><\/p>\n<p>Yilmaz Mahshid, Finansdirekt\u00f6r<br \/>\nTel. 072 231 68 00<br \/>\n<a href=\"mailto:yilmaz.mahshid@pledpharma.se\">yilmaz.mahshid@pledpharma.se<\/a><\/p>\n<p><strong>PledPharma i korthet <\/strong><\/p>\n<p>PledPharma \u00e4r ett innovativt, unikt och integrerat l\u00e4kemedelsutvecklingsbolag, fokuserad p\u00e5 att f\u00f6rb\u00e4ttra behandlingen av handikappande och livshotande sjukdomstillst\u00e5nd. Bolagets l\u00e4ngst framskridna projekt PledOx\u00ae utvecklas f\u00f6r att minska nervskador i samband med cellgiftsbehandling. Ett globalt fas III-program p\u00e5g\u00e5r. Aladote\u00ae utvecklas f\u00f6r att minska risken f\u00f6r akut leverskada i samband med paracetamolf\u00f6rgiftning. En proof-of-principle studie i patienter med paracetamolf\u00f6rgiftning har framg\u00e5ngsrikt genomf\u00f6rts och utg\u00f6r nu grunden f\u00f6r den fortsatta utvecklingen. PledPharma (STO:PLED) \u00e4r listat p\u00e5 Nasdaq First North. Erik Penser Bank \u00e4r Certified Adviser (tfn 08-463 83 00, certifiedadviser@penser.se). F\u00f6r mer information, se <a href=\"https:\/\/www.egetis.com\">www.pledpharma.se<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; Webbs\u00e4ndning Kapitalmarknadsdag Presentationen (.pdf) Stockholm, 26 mars 2019. PledPharma AB (publ) \u00e4r idag v\u00e4rd f\u00f6r en kapitalmarknadsdag d\u00e4r bolagets utvecklingsprogram kommer att presenteras, inklusive m\u00f6jligheterna till en breddning av PledOx\u00ae programmet till nya indikationer samt resultaten fr\u00e5n POP studien med Aladote\u00ae. PledPharma \u00e4r ett innovativt, unikt och integrerat l\u00e4kemedelsutvecklingsbolag, fokuserad p\u00e5 att f\u00f6rb\u00e4ttra behandlingen [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4548","post","type-post","status-publish","format-standard","hentry","category-okategoriserad"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PledPharma presenterar bolagets utvecklingsprogram p\u00e5 kapitalmarknadsdag i Stockholm - Egetis Therapeutics<\/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.egetis.com\/sv\/pledpharma-presenterar-bolagets-utvecklingsprogram-pa-kapitalmarknadsdag-i-stockholm\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PledPharma presenterar bolagets utvecklingsprogram p\u00e5 kapitalmarknadsdag i Stockholm - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"&nbsp; Webbs\u00e4ndning Kapitalmarknadsdag Presentationen (.pdf) Stockholm, 26 mars 2019. PledPharma AB (publ) \u00e4r idag v\u00e4rd f\u00f6r en kapitalmarknadsdag d\u00e4r bolagets utvecklingsprogram kommer att presenteras, inklusive m\u00f6jligheterna till en breddning av PledOx\u00ae programmet till nya indikationer samt resultaten fr\u00e5n POP studien med Aladote\u00ae. PledPharma \u00e4r ett innovativt, unikt och integrerat l\u00e4kemedelsutvecklingsbolag, fokuserad p\u00e5 att f\u00f6rb\u00e4ttra behandlingen [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-bolagets-utvecklingsprogram-pa-kapitalmarknadsdag-i-stockholm\/\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" \/>\n<meta property=\"article:published_time\" content=\"2019-03-26T07:15:26+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-03-29T14:47:28+00:00\" \/>\n<meta name=\"author\" content=\"Jakob Ivarsson\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Skriven av\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jakob Ivarsson\" \/>\n\t<meta name=\"twitter:label2\" content=\"Ber\u00e4knad l\u00e4stid\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minuter\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-bolagets-utvecklingsprogram-pa-kapitalmarknadsdag-i-stockholm\/\",\"url\":\"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-bolagets-utvecklingsprogram-pa-kapitalmarknadsdag-i-stockholm\/\",\"name\":\"PledPharma presenterar bolagets utvecklingsprogram p\u00e5 kapitalmarknadsdag i Stockholm - Egetis Therapeutics\",\"isPartOf\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/#website\"},\"datePublished\":\"2019-03-26T07:15:26+00:00\",\"dateModified\":\"2019-03-29T14:47:28+00:00\",\"author\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/e011ef98939540a4da6d3c07289f970c\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-bolagets-utvecklingsprogram-pa-kapitalmarknadsdag-i-stockholm\/#breadcrumb\"},\"inLanguage\":\"sv-SE\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-bolagets-utvecklingsprogram-pa-kapitalmarknadsdag-i-stockholm\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-bolagets-utvecklingsprogram-pa-kapitalmarknadsdag-i-stockholm\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\/\/www.egetis.com\/sv\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"PledPharma presenterar bolagets utvecklingsprogram p\u00e5 kapitalmarknadsdag i Stockholm\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#website\",\"url\":\"https:\/\/www.egetis.com\/sv\/\",\"name\":\"Egetis Therapeutics\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.egetis.com\/sv\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"sv-SE\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/e011ef98939540a4da6d3c07289f970c\",\"name\":\"Jakob Ivarsson\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"sv-SE\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/5533c578f8531a8b79ed01ab3270d10410d2405da3934c2105cad3963de7eb62?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/5533c578f8531a8b79ed01ab3270d10410d2405da3934c2105cad3963de7eb62?s=96&d=mm&r=g\",\"caption\":\"Jakob Ivarsson\"},\"sameAs\":[\"http:\/\/www.stakeholder.se\"],\"url\":\"https:\/\/www.egetis.com\/sv\/author\/pled-jakob\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"PledPharma presenterar bolagets utvecklingsprogram p\u00e5 kapitalmarknadsdag i Stockholm - Egetis Therapeutics","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.egetis.com\/sv\/pledpharma-presenterar-bolagets-utvecklingsprogram-pa-kapitalmarknadsdag-i-stockholm\/","og_locale":"sv_SE","og_type":"article","og_title":"PledPharma presenterar bolagets utvecklingsprogram p\u00e5 kapitalmarknadsdag i Stockholm - Egetis Therapeutics","og_description":"&nbsp; Webbs\u00e4ndning Kapitalmarknadsdag Presentationen (.pdf) Stockholm, 26 mars 2019. PledPharma AB (publ) \u00e4r idag v\u00e4rd f\u00f6r en kapitalmarknadsdag d\u00e4r bolagets utvecklingsprogram kommer att presenteras, inklusive m\u00f6jligheterna till en breddning av PledOx\u00ae programmet till nya indikationer samt resultaten fr\u00e5n POP studien med Aladote\u00ae. 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fr\u00e5n POP studien st\u00f6djer fortsatt utveckling av Aladote\u00ae som en ny behandling f\u00f6r att minska leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning"},"content":{"rendered":"<p><strong>Stockholm, 26 mars 2019. <\/strong><strong>PledPharma AB (publ) presenterar idag mer data from Proof of Principle (POP) studien. Andelen patienter i behov av ytterligare NAC behandling efter den planerade 12 timmars NAC behandlingen var 50% i NAC gruppen och 11% i NAC+Aladote\u00ae grupperna. <\/strong><\/p>\n<p>Den vetenskapliga principen, s\u00e5v\u00e4l som de kliniska resultaten fr\u00e5n den genomf\u00f6rda POP studien, indikerar att Aladote\u00ae i kombination med NAC har potential att reducera leverskadorna f\u00f6r patienter med paracetamol \u00f6verdos. Sammanfattning av POP studiens resultat:<\/p>\n<ul>\n<li>Aladote\u00ae \u00e4r s\u00e4kert och tolerabelt n\u00e4r det ges tillsammans med NAC till f\u00f6ljd av paracetamolf\u00f6rgiftning<\/li>\n<li>Aladote\u00ae behandling kan potentiellt reducera paracetamol-inducerad leverskada<\/li>\n<li>Biomark\u00f6rer f\u00f6r leverskada:\n<ul>\n<li>Alla patienter behandlade med endast NAC hade en \u00f6kning av b\u00e5da isoformerna av K18, som korrelerar med levercelld\u00f6d\n<ul>\n<li>K18 (patienter med minskade niv\u00e5er fr\u00e5n start av behandling till 20 timmar: n (%)): Endast NAC: 0 (0%); NAC+Aladote: 6 (33%)<\/li>\n<li>CCK18 (patienter med minskade niv\u00e5er fr\u00e5n start av behandling till 20 timmar: n (%)): Endast NAC: 0 (0%); NAC+Aladote: 7 (39%)<\/li>\n<\/ul>\n<\/li>\n<li>miR-122 (patienter med minskade niv\u00e5er fr\u00e5n start av behandling till 20 timmar: n (%)): Endast NAC: 2 (33%); NAC+Aladote: 11 (61%)<\/li>\n<\/ul>\n<\/li>\n<li>Patienter i behov av ytterligare NAC behandling efter den planerade 12 timmars NAC behandlingen, n (%): NAC alone: 3 (50%); NAC+Aladote: 2 (11%)<\/li>\n<\/ul>\n<p>PledPharma avser att diskutera den fortsatta utvecklingen fram\u00e5t f\u00f6r Aladote\u00ae med regulatoriska myndigheter.<\/p>\n<p>Dr James Dear, pr\u00f6vningsledare, kommer att presentera resultaten p\u00e5 PledPharmas kapitalmarknadsdag. Dr Dear, en internationellt ledande expert inom behandling av paracetamolf\u00f6rgiftning, har varit pr\u00f6vningsledare f\u00f6r POP studien som genomf\u00f6rdes vid Royal Infirmary of Edinburgh och The Queen\u2019s Medical Research Institute, University of Edinburgh.<\/p>\n<p>\u201dVi \u00e4r mycket glada att se effekter p\u00e5 kliniskt relevanta mark\u00f6rer i termer av minskat behov av fortsatt NAC i patienter behandlade med Aladote\u00ae, vilket har potentialen att minska sjukhusvistelsen f\u00f6r dessa patienter. Efter dessa resultat och nyligen beviljad s\u00e4rl\u00e4kemedelsstatus ser vi fram emot den fortsatta utvecklingen av Aladote\u00ae.\u201d s\u00e4ger Nicklas Westerholm, vd, PledPharma AB.<\/p>\n<p><strong>F\u00f6r ytterligare information, kontakta:<\/strong><\/p>\n<p>Nicklas Westerholm, Verkst\u00e4llande direkt\u00f6r<br \/>\nTel. 073 354 20 62<br \/>\n<a href=\"mailto:nicklas.westerholm@pledpharma.se\">nicklas.westerholm@pledpharma.se<\/a><\/p>\n<p>Yilmaz Mahshid, Finansdirekt\u00f6r<br \/>\nTel. 072 231 68 00<br \/>\n<a href=\"mailto:yilmaz.mahshid@pledpharma.se\">yilmaz.mahshid@pledpharma.se<\/a><\/p>\n<p><strong>Om <\/strong><strong>Aladote<\/strong><strong>\u00ae<\/strong><\/p>\n<p>Aladote\u00ae \u00e4r en \u201dfirst-in-class\u201d l\u00e4kemedelskandidat som utvecklas f\u00f6r att minska leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning. Aladote\u00ae har i relevanta prekliniska studier visat god effekt \u00e4ven i det tidsf\u00f6nster d\u00e4r behandling med N-acetylcystein (NAC) inte l\u00e4ngre fungerar tillfredsst\u00e4llande (&gt;8 timmar). En proof of principle studie i patienter med paracetamolf\u00f6rgiftning f\u00f6r att f\u00f6rebygga akut leversvikt har framg\u00e5ngsrikt slutf\u00f6rts. Aladote\u00ae har beviljats s\u00e4rl\u00e4kemedelsstatus i USA.<\/p>\n<p>Paracetamol \u00e4r ett av det mest anv\u00e4nda l\u00e4kemedlet i v\u00e4rlden vid behandling av feber och sm\u00e4rttillst\u00e5nd, men samtidigt ett av de l\u00e4kemedel som oftast \u00f6verdoseras \u2013 avsiktligt eller oavsiktligt. Avsiktlig \u00f6verdosering av paracetamol \u00e4r en av de vanligaste metoderna vid sj\u00e4lvmordsf\u00f6rs\u00f6k. N\u00e4r alltf\u00f6r stora m\u00e4ngder paracetamol bryts ner i levern, bildas den skadliga metaboliten NAPQI, som kan orsaka akut leversvikt. Den befintliga behandlingen vid \u00f6verdosering (NAC) \u00e4r som effektivast om den ges inom \u00e5tta timmar efter intag av paracetamol. F\u00f6r patienter som anl\u00e4nder till sjukhus senare \u00e4n s\u00e5 finns idag inget v\u00e4l fungerande behandlingsalternativ.<\/p>\n<p><strong>PledPharma i korthet <\/strong><\/p>\n<p>PledPharma \u00e4r ett innovativt, unikt och integrerat l\u00e4kemedelsutvecklingsbolag, fokuserad p\u00e5 att f\u00f6rb\u00e4ttra behandlingen av handikappande och livshotande sjukdomstillst\u00e5nd. Bolagets l\u00e4ngst framskridna projekt PledOx\u00ae utvecklas f\u00f6r att minska nervskador i samband med cellgiftsbehandling. Ett globalt fas III-program p\u00e5g\u00e5r. Aladote\u00ae utvecklas f\u00f6r att minska risken f\u00f6r akut leverskada i samband med paracetamolf\u00f6rgiftning. En proof-of-principle studie i patienter med paracetamolf\u00f6rgiftning har framg\u00e5ngsrikt genomf\u00f6rts och utg\u00f6r nu grunden f\u00f6r den fortsatta utvecklingen. PledPharma (STO:PLED) \u00e4r listat p\u00e5 Nasdaq First North. Erik Penser Bank \u00e4r Certified Adviser (tfn 08-463 83 00, certifiedadviser@penser.se). F\u00f6r mer information, se <a href=\"https:\/\/www.egetis.com\">www.pledpharma.se<\/a>.<\/p>\n<p><strong>Om biomark\u00f6rer f\u00f6r leverskada<\/strong><\/p>\n<p><strong>Keratin-18 (K18)<\/strong><\/p>\n<p>Vid \u00f6verdosering av paracetamol fris\u00e4tts full\u00e4ngds-versionen av K18 (FLK18) genom nekrotisk celld\u00f6d. En kortare, kaspas-kluven form av K18 (CCK18) fris\u00e4tts efter cellapoptos (programmerad celld\u00f6d). B\u00e5da formerna av K18, uppm\u00e4tta i det f\u00f6rsta provet vid ankomst till sjukhus efter \u00f6verdosering av paracetamol, korrelerar med den h\u00f6gsta uppm\u00e4tta ALT-aktiviteten under sjukhusvistelsen. Full\u00e4ngds-K18 kan s\u00e4rskilja patienter med och utan akut leverskada i ett tidigt skede, d\u00e4r ALT-aktiviteten fortfarande \u00e4r normal. Detta \u00e4r f\u00f6renligt med att nekros \u00e4r mer framtr\u00e4dande \u00e4n apoptos i patofysiologin vid paracetamolinducerad akut leverskada.<\/p>\n<p>Referenser: JW Dear et al. Lancet Gastroenterol Hepatol 2018; 3: 104-13; ADB Vliegenthart et al. Br J Clin Pharmacol. 2015; 80: 351-362.<\/p>\n<p><strong>microRNA-122 (miR-122)<\/strong><\/p>\n<p>miR-122 \u00e4r en biomark\u00f6r som \u00e4r specifik f\u00f6r leverskada och fullst\u00e4ndigt translationell mellan in vitro-modeller, in vivo-modeller och m\u00e4nniskor. miR-122 \u00e4r en tidig mark\u00f6r f\u00f6r akut leverskada som f\u00f6rutsp\u00e5r en \u00f6kning av ALT-aktiviteten efter \u00f6verdosering av paracetamol. N\u00e4r miR-122 m\u00e4ttes under sjukhusv\u00e5rd efter \u00f6verdosering av paracetamol hos patienter som kr\u00e4vde efterf\u00f6ljande NAC-terapi, var den cirkulerande miR-122-koncentrationen signifikant korrelerad med den h\u00f6gsta ALT-aktivitet som uppm\u00e4ttes under sjukhusvistelsen. miR-122 var signifikant h\u00f6gre hos de patienter som utvecklade efterf\u00f6ljande akut leverskada. miR-122 kan med precision separera patienter med och utan akut leverskada i ett tidigt skede, d\u00e5 ALT-aktiviteten fortfarande \u00e4r normal. Detta \u00f6verensst\u00e4mmer med att miR-122 har \u00f6kad k\u00e4nslighet och specificitet i detta sammanhang.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Stockholm, 26 mars 2019. PledPharma AB (publ) presenterar idag mer data from Proof of Principle (POP) studien. Andelen patienter i behov av ytterligare NAC behandling efter den planerade 12 timmars NAC behandlingen var 50% i NAC gruppen och 11% i NAC+Aladote\u00ae grupperna. Den vetenskapliga principen, s\u00e5v\u00e4l som de kliniska resultaten fr\u00e5n den genomf\u00f6rda POP studien, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4543","post","type-post","status-publish","format-standard","hentry","category-okategoriserad"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Resultat fr\u00e5n POP studien st\u00f6djer fortsatt utveckling av Aladote\u00ae som en ny behandling f\u00f6r att minska leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning - Egetis Therapeutics<\/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.egetis.com\/sv\/resultat-fran-pop-studien-stodjer-fortsatt-utveckling-av-aladote-som-en-ny-behandling-for-att-minska-leverskador-till-foljd-av-paracetamolforgiftning\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Resultat fr\u00e5n POP studien st\u00f6djer fortsatt utveckling av Aladote\u00ae som en ny behandling f\u00f6r att minska leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"Stockholm, 26 mars 2019. PledPharma AB (publ) presenterar idag mer data from Proof of Principle (POP) studien. Andelen patienter i behov av ytterligare NAC behandling efter den planerade 12 timmars NAC behandlingen var 50% i NAC gruppen och 11% i NAC+Aladote\u00ae grupperna. 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Helene kommer senast fr\u00e5n en roll som Senior Director, Global Value Chain Leader inom Global Operational Excellence, AstraZeneca.<\/p>\n<p>Helene har under sin tid p\u00e5 AstraZeneca ansvarat f\u00f6r och lett ett stort antal globala kliniska studier och program med omfattande tv\u00e4rfunktionella organisationer i sen utvecklingsfas, som har lett till att produkter registrerats p\u00e5 marknaden t ex BRILINTA<strong>\u00ae<\/strong>.<\/p>\n<p>Helene har en civilingenj\u00f6rsexamen i kemi, Chalmers Tekniska H\u00f6gskola och en MBA, Handelsh\u00f6gskolan G\u00f6teborg.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Helene Depui Ekdal b\u00f6rjade som Clinical Development Director p\u00e5 PledPharma vid m\u00e5nadsskiftet januari\/februari. Helene har en mycket omfattande erfarenhet av l\u00e4kemedelsutveckling fr\u00e5n 25 \u00e5r p\u00e5 AstraZeneca, framf\u00f6r allt genom roller med ansvar f\u00f6r kliniska studier och dess delar \u2013 planering, genomf\u00f6rande, utl\u00e4sning och rapportering. Helene kommer senast fr\u00e5n en roll som Senior Director, Global Value [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4043","post","type-post","status-publish","format-standard","hentry","category-okategoriserad"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Helene Depui Ekdal ny Clinical Development Director - Egetis Therapeutics<\/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.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Helene Depui Ekdal ny Clinical Development Director - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"Helene Depui Ekdal b\u00f6rjade som Clinical Development Director p\u00e5 PledPharma vid m\u00e5nadsskiftet januari\/februari. Helene har en mycket omfattande erfarenhet av l\u00e4kemedelsutveckling fr\u00e5n 25 \u00e5r p\u00e5 AstraZeneca, framf\u00f6r allt genom roller med ansvar f\u00f6r kliniska studier och dess delar \u2013 planering, genomf\u00f6rande, utl\u00e4sning och rapportering. Helene kommer senast fr\u00e5n en roll som Senior Director, Global Value [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" \/>\n<meta property=\"article:published_time\" content=\"2019-02-11T09:35:55+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-11T17:51:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.egetis.com\/wp-content\/uploads\/Helene-small-1-300x225.jpg\" \/>\n<meta name=\"author\" content=\"Jakob Ivarsson\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Skriven av\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jakob Ivarsson\" \/>\n\t<meta name=\"twitter:label2\" content=\"Ber\u00e4knad l\u00e4stid\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minut\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/\",\"url\":\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/\",\"name\":\"Helene Depui Ekdal ny Clinical Development Director - Egetis Therapeutics\",\"isPartOf\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.egetis.com\/wp-content\/uploads\/Helene-small-1-300x225.jpg\",\"datePublished\":\"2019-02-11T09:35:55+00:00\",\"dateModified\":\"2019-02-11T17:51:16+00:00\",\"author\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/e011ef98939540a4da6d3c07289f970c\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/#breadcrumb\"},\"inLanguage\":\"sv-SE\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"sv-SE\",\"@id\":\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/#primaryimage\",\"url\":\"https:\/\/www.egetis.com\/wp-content\/uploads\/Helene-small-1-300x225.jpg\",\"contentUrl\":\"https:\/\/www.egetis.com\/wp-content\/uploads\/Helene-small-1-300x225.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\/\/www.egetis.com\/sv\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Helene Depui Ekdal ny Clinical Development Director\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#website\",\"url\":\"https:\/\/www.egetis.com\/sv\/\",\"name\":\"Egetis Therapeutics\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.egetis.com\/sv\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"sv-SE\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/e011ef98939540a4da6d3c07289f970c\",\"name\":\"Jakob Ivarsson\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"sv-SE\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/5533c578f8531a8b79ed01ab3270d10410d2405da3934c2105cad3963de7eb62?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/5533c578f8531a8b79ed01ab3270d10410d2405da3934c2105cad3963de7eb62?s=96&d=mm&r=g\",\"caption\":\"Jakob Ivarsson\"},\"sameAs\":[\"http:\/\/www.stakeholder.se\"],\"url\":\"https:\/\/www.egetis.com\/sv\/author\/pled-jakob\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Helene Depui Ekdal ny Clinical Development Director - Egetis Therapeutics","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.egetis.com\/sv\/helene-depui-ekdal-ny-clinical-development-director\/","og_locale":"sv_SE","og_type":"article","og_title":"Helene Depui Ekdal ny Clinical Development Director - Egetis Therapeutics","og_description":"Helene Depui Ekdal b\u00f6rjade som Clinical Development Director p\u00e5 PledPharma vid m\u00e5nadsskiftet januari\/februari. 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PledPharma has the pleasure of inviting investors, financial analysts and media to PledPharma\u2019s Capital Markets Day (CMD) on 26th March 2019.<\/strong><\/p>\n<p>PledPharma is an innovative, unique and integrated pharmaceutical drug development company, focusing on improving treatments for diseases with substantial unmet medical need. The company has the pleasure of inviting investors, financial analysts and media to PledPharma\u2019s Capital Markets Day (CMD) on 26th March 2019.<\/p>\n<p>Time: Tuesday March 26th, at 10:00-15:00 CET<br \/>\nVenue: Redeye, M\u00e4ster Samuelsgatan 42, 10th floor, Stockholm<\/p>\n<p>During the CMD, the company will provide an update and in-depth view on the company strategy and its assets covering the unmet medical need, commercial opportunities, development plans and additional activities to create and enhance value.<\/p>\n<p>Speakers at the CMD include the Chairman of the Board, H\u00e5kan \u00c5str\u00f6m, the CEO, Nicklas Westerholm and members from the management team as well as two key opinion leaders, Dr. James Dear, Edinburgh University and Prof. Per Pfeiffer, Odense University.<\/p>\n<p>Presentations are held in English and a complete agenda will be presented in advance of the event.<\/p>\n<p>The CMD will be broadcasted live at <a href=\"http:\/\/www.redeye.se\/live\/pled-kapitalmarknadsdag-2019\">www.redeye.se\/live\/pled-kapitalmarknadsdag-2019<\/a><\/p>\n<p>To attend &#8211; <a href=\"https:\/\/www.lyyti.fi\/reg\/PledPharma_Kapitalmarknadsdag_7586\">sign up here!<\/a><\/p>\n<p><strong>For further information, please contact:<\/strong><br \/>\nYilmaz Mahshid, CFO<br \/>\nTel. +46-(0)72 231 68 00<br \/>\n<a href=\"mailto:yilmaz.mahshid@pledpharma.se\">yilmaz.mahshid@pledpharma.se<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Stockholm, February 5, 2019. PledPharma has the pleasure of inviting investors, financial analysts and media to PledPharma\u2019s Capital Markets Day (CMD) on 26th March 2019. PledPharma is an innovative, unique and integrated pharmaceutical drug development company, focusing on improving treatments for diseases with substantial unmet medical need. The company has the pleasure of inviting investors, [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4002","post","type-post","status-publish","format-standard","hentry","category-okategoriserad"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PledPharma Kapitalmarknadsdag - Egetis Therapeutics<\/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.egetis.com\/sv\/pledpharma-kapitalmarknadsdag\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PledPharma Kapitalmarknadsdag - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"Stockholm, February 5, 2019. PledPharma has the pleasure of inviting investors, financial analysts and media to PledPharma\u2019s Capital Markets Day (CMD) on 26th March 2019. PledPharma is an innovative, unique and integrated pharmaceutical drug development company, focusing on improving treatments for diseases with substantial unmet medical need. The company has the pleasure of inviting investors, [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/pledpharma-kapitalmarknadsdag\/\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" \/>\n<meta property=\"article:published_time\" content=\"2019-02-05T12:52:05+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-07T16:53:49+00:00\" \/>\n<meta name=\"author\" content=\"Jakob Ivarsson\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Skriven av\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jakob Ivarsson\" \/>\n\t<meta name=\"twitter:label2\" content=\"Ber\u00e4knad l\u00e4stid\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minut\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-kapitalmarknadsdag\/\",\"url\":\"https:\/\/www.egetis.com\/sv\/pledpharma-kapitalmarknadsdag\/\",\"name\":\"PledPharma Kapitalmarknadsdag - Egetis Therapeutics\",\"isPartOf\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/#website\"},\"datePublished\":\"2019-02-05T12:52:05+00:00\",\"dateModified\":\"2019-02-07T16:53:49+00:00\",\"author\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/e011ef98939540a4da6d3c07289f970c\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-kapitalmarknadsdag\/#breadcrumb\"},\"inLanguage\":\"sv-SE\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.egetis.com\/sv\/pledpharma-kapitalmarknadsdag\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-kapitalmarknadsdag\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\/\/www.egetis.com\/sv\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"PledPharma Kapitalmarknadsdag\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#website\",\"url\":\"https:\/\/www.egetis.com\/sv\/\",\"name\":\"Egetis Therapeutics\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.egetis.com\/sv\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"sv-SE\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/e011ef98939540a4da6d3c07289f970c\",\"name\":\"Jakob Ivarsson\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"sv-SE\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/5533c578f8531a8b79ed01ab3270d10410d2405da3934c2105cad3963de7eb62?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/5533c578f8531a8b79ed01ab3270d10410d2405da3934c2105cad3963de7eb62?s=96&d=mm&r=g\",\"caption\":\"Jakob Ivarsson\"},\"sameAs\":[\"http:\/\/www.stakeholder.se\"],\"url\":\"https:\/\/www.egetis.com\/sv\/author\/pled-jakob\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"PledPharma Kapitalmarknadsdag - Egetis Therapeutics","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.egetis.com\/sv\/pledpharma-kapitalmarknadsdag\/","og_locale":"sv_SE","og_type":"article","og_title":"PledPharma Kapitalmarknadsdag - Egetis Therapeutics","og_description":"Stockholm, February 5, 2019. 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Dr James Dear, en internationellt ledande expert inom behandling av paracetamolf\u00f6rgiftning, har varit pr\u00f6vningsledare f\u00f6r proof of principle-fas Ib\/IIa-studien som utf\u00f6rdes vid Royal Infirmary of Edinburgh och The Queen\u2019s Medical Research Institute, University of Edinburgh.<\/p>\n<p>\u201dDet \u00e4r en stor \u00e4ra att f\u00e5 presentera v\u00e5ra studieresultat p\u00e5 EASL, en av de st\u00f6rsta och mest respekterade globala hepatologikonferenserna. V\u00e5r studie var en av de f\u00f6rsta tidiga kliniska studierna inom \u00f6verdosering av paracetamol, ett omr\u00e5de med stort kliniskt behov och en v\u00e4ldig vanlig orsak till intag av patienter inom akutv\u00e5rden\u201d s\u00e4ger Dr. James Dear, University of Edinburgh.<\/p>\n<p>\u201dVi \u00e4r oerh\u00f6rt stolta \u00f6ver att ha blivit valda till att h\u00e5lla en muntlig presentation p\u00e5 The International Liver Congress. Att f\u00e5 presentera Aladotes\u00ae studieresultat p\u00e5 en av de globalt mest erk\u00e4nda leverkonferenserna \u00e4r ett erk\u00e4nnande av intresset i Aladotes\u00ae potential och det medicinska behovet i denna patientpopulation.\u201d s\u00e4ger Nicklas Westerholm, vd, PledPharma AB.<\/p>\n<p><strong>M\u00f6tesinformation:<\/strong> EASL ILC 2019 Vienna, Austria, 10-14 April 2019<\/p>\n<p><strong>Abstract number:<\/strong> 2299. Abstract title: PP100-01 (calmangafodipir) for overdose of paracetamol (The POP trial): Principal results.<\/p>\n<p><strong>F\u00f6r ytterligare information, kontakta:<\/strong><\/p>\n<p>Nicklas Westerholm, Verkst\u00e4llande direkt\u00f6r<br \/>\nTel. 073 354 20 62<br \/>\nnicklas.westerholm@pledpharma.se<\/p>\n<p>Yilmaz Mahshid, Finansdirekt\u00f6r<br \/>\nTel. 072 231 68 00<br \/>\nyilmaz.mahshid@pledpharma.se<\/p>\n<p><strong>Om <\/strong><strong>Aladote<\/strong><strong>\u00ae<\/strong><\/p>\n<p>Aladote\u00ae \u00e4r en \u201dfirst-in-class\u201d l\u00e4kemedelskandidat som utvecklas f\u00f6r att minska leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning. Aladote\u00ae har i relevanta prekliniska studier visat god effekt \u00e4ven i det tidsf\u00f6nster d\u00e4r behandling med N-acetylcystein (NAC) inte l\u00e4ngre fungerar tillfredsst\u00e4llande (&gt;8 timmar). En proof of principle studie i patienter med paracetamolf\u00f6rgiftning f\u00f6r att f\u00f6rebygga akut leversvikt har framg\u00e5ngsrikt slutf\u00f6rts.<\/p>\n<p>Paracetamol \u00e4r ett av det mest anv\u00e4nda l\u00e4kemedlet i v\u00e4rlden vid behandling av feber och sm\u00e4rttillst\u00e5nd, men samtidigt ett av de l\u00e4kemedel som oftast \u00f6verdoseras \u2013 avsiktligt eller oavsiktligt. Avsiktlig \u00f6verdosering av paracetamol \u00e4r en av de vanligaste metoderna vid sj\u00e4lvmordsf\u00f6rs\u00f6k. N\u00e4r alltf\u00f6r stora m\u00e4ngder paracetamol bryts ner i levern, bildas den skadliga metaboliten NAPQI, som kan orsaka akut leversvikt. Den befintliga behandlingen vid \u00f6verdosering (NAC) \u00e4r som effektivast om den ges inom \u00e5tta timmar efter intag av paracetamol. F\u00f6r patienter som anl\u00e4nder till sjukhus senare \u00e4n s\u00e5 finns idag inget v\u00e4l fungerande behandlingsalternativ.<\/p>\n<p><strong>PledPharma i korthet<br \/>\n<\/strong>PledPharma utvecklar nya l\u00e4kemedel som syftar till att skydda kroppen mot oxidativ stress \u2013 ett potentiellt handikappande och ibland livshotande tillst\u00e5nd som kan orsakas av bland annat cellgiftsbehandling och paracetamolf\u00f6rgiftning. Bolagets l\u00e4ngst framskridna projekt PledOx\u00ae utvecklas f\u00f6r att minska nervskador i samband med cellgiftsbehandling. En fas II-studie har genomf\u00f6rts och utg\u00f6r grunden f\u00f6r det initierade globala fas III-programmet. Aladote\u00ae utvecklas f\u00f6r att minska risken f\u00f6r akut leversvikt i samband med paracetamolf\u00f6rgiftning. En proof-of-principle studie i patienter med paracetamolf\u00f6rgiftning har framg\u00e5ngsrikt genomf\u00f6rts och utg\u00f6r nu grunden f\u00f6r den fortsatta utvecklingen. PledPharma (STO:PLED) \u00e4r listat p\u00e5 Nasdaq First North. Erik Penser Bank \u00e4r Certified Adviser (tfn 08-463 83 00, certifiedadviser@penser.se). F\u00f6r mer information, se <a href=\"https:\/\/www.egetis.com\">www.pledpharma.se<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Stockholm, 31 januari 2019. PledPharma AB (publ) meddelar att abstraktet med de positiva resultaten fr\u00e5n Aladotes\u00ae Fas Ib\/IIa proof of principle-studie har utvalts f\u00f6r muntlig presentation p\u00e5 den globala konferensen EASL ILC 2019. EASL ILC, ocks\u00e5 k\u00e4nd som The International Liver Congress, \u00e4r en av de globalt st\u00f6rsta vetenskapliga konferenserna inom Hepatologi (leversjukdomar) och p\u00e5g\u00e5r [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3951","post","type-post","status-publish","format-standard","hentry","category-okategoriserad"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Aladotes\u00ae resultat \u00e4r utvald f\u00f6r presentation p\u00e5 The International Liver Congress - Egetis Therapeutics<\/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.egetis.com\/sv\/aladotes-resultat-ar-utvald-for-presentation-pa-the-international-liver-congress\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Aladotes\u00ae resultat \u00e4r utvald f\u00f6r presentation p\u00e5 The International Liver Congress - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"Stockholm, 31 januari 2019. 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presenterar l\u00e4kemedelskandidaten PledOx\u00ae fas III-program p\u00e5 global cancerkonferens"},"content":{"rendered":"<p><strong>Stockholm, 17 januari 2019. <\/strong><strong>PledPharma AB (publ) meddelar att bolagets globala fas III-program, POLAR, f\u00f6r PledOx\u00ae har accepterats f\u00f6r poster-presentation p\u00e5 den globala konferensen Gastrointestinal (GI) Cancers Symposium 17-19 januari i San Francisco.<\/strong><\/p>\n<p>Konferensen \u00e4r en av de viktigaste l\u00e4kemedelskonferenserna inom mag-\/tarmcancer globalt d\u00e4r bland annat ASCO (American Association of Clinical Oncology) st\u00e5r som en av huvudsponsorerna.<\/p>\n<p>Rubriken p\u00e5 presentationen \u00e4r: The Global POLAR program: Calmangafodipir used on top of modified FOLFOX6 (5-FU\/FA and oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN). Presentat\u00f6rer \u00e4r en av de ansvariga l\u00e4karna f\u00f6r programmet Prof. Per Pfeiffer fr\u00e5n Odense universitetssjukhus och PledPharmas Chief Medical Officer Stefan Carlsson.<\/p>\n<p>\u201dVi \u00e4r \u00e4n en g\u00e5ng stolta \u00f6ver att ha blivit en av de utvalda presentat\u00f6rerna, denna g\u00e5ngen p\u00e5 ASCO GI. Detta visar p\u00e5 stort intresse f\u00f6r v\u00e5r l\u00e4kemedelskandidat PledOx\u00ae och dess fas III-program POLAR. Att f\u00e5 presentera programmet p\u00e5 en av de globalt viktigaste mag-\/tarm-cancerkonferenserna ser jag som en bekr\u00e4ftelse p\u00e5 intresset f\u00f6r PledOx\u00ae potential och det medicinska behovet i denna patientpopulation.\u201d s\u00e4ger Nicklas Westerholm, vd, PledPharma AB.<\/p>\n<p>M\u00f6tesinformation:<\/p>\n<p>Abstract number: TPS722. Poster Board: Q7. Session information: Trials in progress poster session C. Cancer of the Colon, Rectum and Anus<\/p>\n<p>&nbsp;<\/p>\n<p><strong>F\u00f6r ytterligare information, kontakta:<br \/>\n<\/strong>Nicklas Westerholm, Verkst\u00e4llande direkt\u00f6r<br \/>\nTel. 073 354 20 62<br \/>\n<a href=\"mailto:nicklas.westerholm@pledpharma.se\">nicklas.westerholm@pledpharma.se<\/a><\/p>\n<p>Yilmaz Mahshid, Finansdirekt\u00f6r<br \/>\nTel. 072 231 68 00<br \/>\n<a href=\"mailto:yilmaz.mahshid@pledpharma.se\">yilmaz.mahshid@pledpharma.se<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Om PledOx<sup>\u00ae<br \/>\n<\/sup><\/strong>PledOx\u00ae \u00e4r en \u201dfirst in class\u201d l\u00e4kemedelskandidat som efterliknar kroppens eget enzymf\u00f6rsvar mot oxidativ stress och utvecklas f\u00f6r att kunna erbjuda patienter med tjock- och \u00e4ndtarmscancer skydd mot de perifera nervskador som ofta uppkommer i samband med cellgiftsbehandling. Resultaten fr\u00e5n en avslutad fas IIb-pr\u00f6vning (PLIANT) i patienter med metastaserad (spridd) tjock- och \u00e4ndtarmscancer som behandlades med cellgiftskombinationen FOLFOX indikerar att de individer som erh\u00f6ll PledOx\u00ae hade en l\u00e4gre risk \u00e4n placebogruppen att drabbas av perifera nervskador. PledOx<sup>\u00ae <\/sup>hade 38% effekt (oddskvot=0.62; p=0.16)\u00a0 med avseende p\u00e5 l\u00e4karrapporterade k\u00e4nselnervskador (prim\u00e4r effektparameter) j\u00e4mf\u00f6rt med placebogruppen. Detta var inte statistiskt signifikant, men en skillnad i denna storleksordning bed\u00f6ms vara kliniskt relevant. Vid uppf\u00f6ljning efter avslutad cellgiftsbehandling hade PledOx<sup>\u00ae <\/sup>77% effekt (oddskvot=0.23; explorativ analys: p=0.014) med avseende p\u00e5 patientrapporterad f\u00f6rekomst av moderat och allvarlig neuropati\u00a0 j\u00e4mf\u00f6rt med placebo. Detta anses v\u00e4rdefullt f\u00f6r m\u00f6jligheten att lyckas i de kommande POLAR-studierna d\u00e4r patientrapporterade symptom efter avslutad behandling kommer utg\u00f6ra prim\u00e4r effektparameter.\u00a0Ingen till synes negativ p\u00e5verkan p\u00e5 cancereffekten av cellgiftsbehandlingen observerades med PledOx\u00ae. Fas III-programmet f\u00f6r PledOx\u00ae best\u00e5r av tv\u00e5 dubbelblinda, randomiserade, placebo-kontrollerade studier, POLAR-M och POLAR-A. POLAR-M inkluderar 420 patienter som genomg\u00e5r cellgiftsbehandling mot metastaserad tjock-och \u00e4ndtarmscancer och planeras att genomf\u00f6ras i Europa, Asien och USA. I studien j\u00e4mf\u00f6rs PledOx\u00ae i doserna 2 \u03bcmol\/kg respektive 5 \u03bcmol\/kg med placebo. POLAR-A inkluderar 280 patienter som genomg\u00e5r adjuvant cellgiftsbehandling mot tjock- och \u00e4ndtarmscancer och planeras att genomf\u00f6ras i Europa och Asien. I studien j\u00e4mf\u00f6rs PledOx\u00ae i dosen 5 \u03bcmol\/kg med placebo.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>PledPharma i korthet<br \/>\n<\/strong>PledPharma utvecklar nya l\u00e4kemedel som syftar till att skydda kroppen mot oxidativ stress \u2013 ett potentiellt handikappande och ibland livshotande tillst\u00e5nd som kan orsakas av bland annat cellgiftsbehandling och paracetamolf\u00f6rgiftning. Bolagets l\u00e4ngst framskridna projekt PledOx\u00ae utvecklas f\u00f6r att minska nervskador i samband med cellgiftsbehandling. En fas II-studie har genomf\u00f6rts och utg\u00f6r grunden f\u00f6r det initierade globala fas III-programmet. Aladote\u00ae utvecklas f\u00f6r att minska risken f\u00f6r akut leversvikt i samband med paracetamolf\u00f6rgiftning. En proof-of-principle studie i patienter med paracetamolf\u00f6rgiftning har framg\u00e5ngsrikt genomf\u00f6rts och utg\u00f6r nu grunden f\u00f6r den fortsatta utvecklingen. PledPharma (STO:PLED) \u00e4r listat p\u00e5 Nasdaq First North. Erik Penser Bank \u00e4r Certified Adviser (tfn 08-463 83 00, certifiedadviser@penser.se). F\u00f6r mer information, se <a href=\"https:\/\/www.egetis.com\">www.pledpharma.se<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Stockholm, 17 januari 2019. PledPharma AB (publ) meddelar att bolagets globala fas III-program, POLAR, f\u00f6r PledOx\u00ae har accepterats f\u00f6r poster-presentation p\u00e5 den globala konferensen Gastrointestinal (GI) Cancers Symposium 17-19 januari i San Francisco. Konferensen \u00e4r en av de viktigaste l\u00e4kemedelskonferenserna inom mag-\/tarmcancer globalt d\u00e4r bland annat ASCO (American Association of Clinical Oncology) st\u00e5r som en [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[41],"tags":[],"class_list":["post-3938","post","type-post","status-publish","format-standard","hentry","category-icke-regulatoriskt"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PledPharma presenterar l\u00e4kemedelskandidaten PledOx\u00ae fas III-program p\u00e5 global cancerkonferens - Egetis Therapeutics<\/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.egetis.com\/sv\/pledpharma-presenterar-lakemedelskandidaten-pledox-fas-iii-program-pa-global-cancerkonferens\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PledPharma presenterar l\u00e4kemedelskandidaten PledOx\u00ae fas III-program p\u00e5 global cancerkonferens - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"Stockholm, 17 januari 2019. PledPharma AB (publ) meddelar att bolagets globala fas III-program, POLAR, f\u00f6r PledOx\u00ae har accepterats f\u00f6r poster-presentation p\u00e5 den globala konferensen Gastrointestinal (GI) Cancers Symposium 17-19 januari i San Francisco. 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PledPharma AB (publ) meddelar att bolagets globala fas III-program, POLAR, f\u00f6r PledOx\u00ae har accepterats f\u00f6r poster-presentation p\u00e5 den globala konferensen Gastrointestinal (GI) Cancers Symposium 17-19 januari i San Francisco. Konferensen \u00e4r en av de viktigaste l\u00e4kemedelskonferenserna inom mag-\/tarmcancer globalt d\u00e4r bland annat ASCO (American Association of Clinical Oncology) st\u00e5r som en [&hellip;]","og_url":"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-lakemedelskandidaten-pledox-fas-iii-program-pa-global-cancerkonferens\/","og_site_name":"Egetis Therapeutics","article_published_time":"2019-01-17T07:05:34+00:00","author":"Jakob Ivarsson","twitter_card":"summary_large_image","twitter_misc":{"Skriven av":"Jakob Ivarsson","Ber\u00e4knad l\u00e4stid":"3 minuter"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-lakemedelskandidaten-pledox-fas-iii-program-pa-global-cancerkonferens\/","url":"https:\/\/www.egetis.com\/sv\/pledpharma-presenterar-lakemedelskandidaten-pledox-fas-iii-program-pa-global-cancerkonferens\/","name":"PledPharma presenterar l\u00e4kemedelskandidaten PledOx\u00ae fas III-program p\u00e5 global cancerkonferens - 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Inklusionen av den f\u00f6rsta patienten utg\u00f6r en viktig milstolpe f\u00f6r b\u00e5da bolagen och utl\u00f6ser en betalning fr\u00e5n PledPharmas samarbetspartner Solasia Pharma om 600 miljoner JPY, motsvararande cirka 49 miljoner SEK.<\/strong><\/p>\n<p>Det globala fas III-programmet f\u00f6r PledOx\u00ae best\u00e5r av tv\u00e5 dubbelblinda, randomiserade, placebo-kontrollerade studier \u2013 POLAR-M och POLAR-A. Fas III-programmet utf\u00f6rs i Europa, Asien och USA, och kommer inkludera totalt 700 tjock- och \u00e4ndtarmscancerpatienter som behandlas med cellgifter. Den f\u00f6rsta patienten i programmet inkluderades i november 2018 vid ett studiecenter i USA, och top line-resultat f\u00f6rv\u00e4ntas under andra halvan av 2020.<\/p>\n<p>PledPharma inledde ett samarbete i november 2017 med det japanska l\u00e4kemedelsf\u00f6retaget Solasia Pharma K.K. vad g\u00e4ller utvecklingen och kommersialiseringen av PledOx\u00ae i Japan, Kina, Hong Kong, Macao, Sydkorea och Taiwan. Det totala v\u00e4rdet p\u00e5 samarbetsavtalet uppg\u00e5r till cirka 83 miljoner USD* (motsvarande cirka 700 miljoner SEK*) och \u00e4r kopplade till f\u00f6rdefinierade milstolpar under den fortsatta utvecklingen och kommersialiseringen av PledOx\u00ae. Solasia Pharma finansierar \u00e4ven den asiatiska delenav POLAR-studierna och har dessutom f\u00f6rbundit sig att betala royaltyers\u00e4ttning p\u00e5 potentiell framtida f\u00f6rs\u00e4ljning av PledOx\u00ae i de ovan n\u00e4mnda l\u00e4nderna.<\/p>\n<p>\u201dSamarbetet med Solasia Pharma \u00e4r en viktig komponent i PledPharmas strategi f\u00f6r att realisera hela den globala kommersiella potentialen av PledOx\u00ae, och det \u00e4r med stor tillfredst\u00e4llelse vi kan konstatera att POLAR-studierna nu inletts \u00e4ven i Asien.\u201d, s\u00e4ger Nicklas Westerholm, vd, PledPharma AB.<\/p>\n<p>\u201dVi \u00e4r v\u00e4ldigt exalterade \u00f6ver att Asien nu \u00e4r en del av det globala Fas III-programmet. Tack vare det dedikerade sammarbetet med PledPharma har vi kunnat n\u00e5 denna viktiga milstolpe p\u00e5 s\u00e5 kort tid.&#8221; s\u00e4ger Yoshihiro Arai, President &amp; CEO, Solasia Pharma K.K<\/p>\n<p>*Det totala v\u00e4rdet \u00e4r 9,3 miljarder JPY. De angivna beloppen i USD och SEK kan komma att p\u00e5verkas av valutafluktuationer.<\/p>\n<p><strong>F\u00f6r ytterligare information, kontakta:<\/strong><br \/>\nNicklas Westerholm, Verkst\u00e4llande direkt\u00f6r<br \/>\n<strong>Tel.<\/strong> 073 354 20 62<br \/>\n<a href=\"mailto:nicklas.westerholm@pledpharma.se\">nicklas.westerholm@pledpharma.se<\/a><\/p>\n<p><strong>Yilmaz Mahshid, Finansdirekt\u00f6r<\/strong><br \/>\n<strong>Tel.<\/strong> 072 231 68 00<br \/>\n<a href=\"mailto:yilmaz.mahshid@pledpharma.se\">yilmaz.mahshid@pledpharma.se<\/a><\/p>\n<hr \/>\n<p><strong>Om PledOx\u00ae<\/strong><br \/>\nPledOx\u00ae \u00e4r en \u201dfirst in class\u201d l\u00e4kemedelskandidat som efterliknar kroppens eget enzymf\u00f6rsvar mot oxidativ stress och utvecklas f\u00f6r att kunna erbjuda patienter med tjock- och \u00e4ndtarmscancer skydd mot de perifera nervskador som ofta uppkommer i samband med cellgiftsbehandling. Resultaten fr\u00e5n en avslutad fas IIb-pr\u00f6vning (PLIANT) i patienter med metastaserad (spridd) tjock- och \u00e4ndtarmscancer som behandlades med cellgiftskombinationen FOLFOX indikerar att de individer som erh\u00f6ll PledOx\u00ae hade en l\u00e4gre risk \u00e4n placebogruppen att drabbas av perifera nervskador. PledOx\u00ae hade 38% effekt (oddskvot=0.62; p=0.16) med avseende p\u00e5 l\u00e4karrapporterade k\u00e4nselnervskador (prim\u00e4r effektparameter) j\u00e4mf\u00f6rt med placebogruppen. Detta var inte statistiskt signifikant, men en skillnad i denna storleksordning bed\u00f6ms vara kliniskt relevant. Vid uppf\u00f6ljning efter avslutad cellgiftsbehandling hade PledOx\u00ae 77% effekt (oddskvot=0.23; explorativ analys: p=0.014) med avseende p\u00e5 patientrapporterad f\u00f6rekomst av moderat och allvarlig neuropati j\u00e4mf\u00f6rt med placebo. Detta anses v\u00e4rdefullt f\u00f6r m\u00f6jligheten att lyckas i de kommande POLAR-studierna d\u00e4r patientrapporterade symptom efter avslutad behandling kommer utg\u00f6ra prim\u00e4r effektparameter. Ingen till synes negativ p\u00e5verkan p\u00e5 cancereffekten av cellgiftsbehandlingen observerades med PledOx\u00ae. Fas III-programmet f\u00f6r PledOx\u00ae best\u00e5r av tv\u00e5 dubbelblinda, randomiserade, placebo-kontrollerade studier, POLAR-M och POLAR-A. POLAR-M inkluderar 420 patienter som genomg\u00e5r cellgiftsbehandling mot metastaserad tjock-och \u00e4ndtarmscancer och planeras att genomf\u00f6ras i Europa, Asien och USA. I studien j\u00e4mf\u00f6rs PledOx\u00ae i doserna 2 \u03bcmol\/kg respektive 5 \u03bcmol\/kg med placebo. POLAR-A inkluderar 280 patienter som genomg\u00e5r adjuvant cellgiftsbehandling mot tjock- och \u00e4ndtarmscancer och planeras att genomf\u00f6ras i Europa och Asien. I studien j\u00e4mf\u00f6rs PledOx\u00ae i dosen 5 \u03bcmol\/kg med placebo.<\/p>\n<p><strong>Cellgiftsinducerad perifer neuropati (CIPN)<\/strong><br \/>\nPerifer neuropati \u00e4r symtom orsakade av skador p\u00e5 tunna k\u00e4nselnervtr\u00e5dar framf\u00f6r allt i h\u00e4nder och f\u00f6tter. Vissa cellgifter, till exempel oxaliplatin och andra l\u00e4kemedel som anv\u00e4nds f\u00f6r att behandla cancer, kan skada dessa perifera k\u00e4nselnerver. Detta kallas cellgiftsinducerad perifer neuropati (CIPN) och kan vara en invalidiserande biverkan av cancerbehandlingen. Hos m\u00e5nga \u00e4r symtomen \u00f6verg\u00e5ende, men 20-30% av patienterna f\u00e5r best\u00e5ende problem s\u00e5som k\u00e4nselbortfall och sm\u00e4rta i h\u00e4nder och f\u00f6tter. Patienterna kan f\u00e5 sv\u00e5righeter med finmotorik, vilket till exempel kan g\u00f6ra det sv\u00e5rt att kn\u00e4ppa knappar, skriva p\u00e5 en dator och bli \u00f6verk\u00e4nsliga mot kyla. K\u00e4nselbortfallet i f\u00f6tterna kan \u00e4ven medf\u00f6ra en \u00f6kad risk f\u00f6r fallskador. N\u00e5got godk\u00e4nt l\u00e4kemedel eller f\u00f6rebyggande behandling mot CIPN finns inte idag. CIPN kan uppst\u00e5 n\u00e4r som helst efter att cellgiftsbehandlingen p\u00e5b\u00f6rjats och symtomen blir ofta v\u00e4rre ju l\u00e4ngre patienten behandlas.<\/p>\n<p><strong>PledPharma i korthet<\/strong><br \/>\nPledPharma utvecklar nya l\u00e4kemedel som syftar till att skydda kroppen mot oxidativ stress \u2013 ett potentiellt handikappande och ibland livshotande tillst\u00e5nd som kan orsakas av bland annat cellgiftsbehandling och paracetamolf\u00f6rgiftning. Bolagets l\u00e4ngst framskridna projekt PledOx\u00ae utvecklas f\u00f6r att minska nervskador i samband med cellgiftsbehandling. En fas II-studie har genomf\u00f6rts och utg\u00f6r grunden f\u00f6r det initierade globala fas III-programmet. Aladote\u00ae utvecklas f\u00f6r att minska risken f\u00f6r akut leversvikt i samband med paracetamolf\u00f6rgiftning. En proof-of-principle studie i patienter med paracetamolf\u00f6rgiftning har framg\u00e5ngsrikt genomf\u00f6rts och utg\u00f6r nu grunden f\u00f6r den fortsatta utvecklingen. PledPharma (STO:PLED) \u00e4r listat p\u00e5 Nasdaq First North. Erik Penser Bank \u00e4r Certified Adviser (tfn 08-463 83 00, certifiedadviser@penser.se). F\u00f6r mer information, se <a href=\"https:\/\/www.egetis.com\/\">www.pledpharma.se<\/a><\/p>\n<p><em>Denna information \u00e4r s\u00e5dan information som PledPharma \u00e4r skyldig att offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning (EU) nr 596\/2014. Informationen l\u00e4mnades enligt ovanst\u00e5ende kontaktpersons f\u00f6rsorg, f\u00f6r offentligg\u00f6rande den 10 januari 2019 kl. 08:00.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PledPharma AB (publ) och Solasia Pharma K.K. meddelar att den f\u00f6rsta patienten i Japan har inkluderats till det globala fas III-programmet f\u00f6r l\u00e4kemedelskandidaten PledOx\u00ae. Inklusionen av den f\u00f6rsta patienten utg\u00f6r en viktig milstolpe f\u00f6r b\u00e5da bolagen och utl\u00f6ser en betalning fr\u00e5n PledPharmas samarbetspartner Solasia Pharma om 600 miljoner JPY, motsvararande cirka 49 miljoner SEK. Det [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3933","post","type-post","status-publish","format-standard","hentry","category-okategoriserad"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PledPharma erh\u00e5ller 600 MJPY, cirka 49 MSEK, i samband med inklusion av den f\u00f6rsta asiatiska patienten i det globala fas III-programmet f\u00f6r PledOx\u00ae - Egetis Therapeutics<\/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.egetis.com\/sv\/pledpharma-erhaller-600-mjpy-cirka-49-msek-i-samband-med-inklusion-av-den-forsta-asiatiska-patienten-i-det-globala-fas-iii-programmet-for-pledox\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PledPharma erh\u00e5ller 600 MJPY, cirka 49 MSEK, i samband med inklusion av den f\u00f6rsta asiatiska patienten i det globala fas III-programmet f\u00f6r PledOx\u00ae - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"PledPharma AB (publ) och Solasia Pharma K.K. meddelar att den f\u00f6rsta patienten i Japan har inkluderats till det globala fas III-programmet f\u00f6r l\u00e4kemedelskandidaten PledOx\u00ae. Inklusionen av den f\u00f6rsta patienten utg\u00f6r en viktig milstolpe f\u00f6r b\u00e5da bolagen och utl\u00f6ser en betalning fr\u00e5n PledPharmas samarbetspartner Solasia Pharma om 600 miljoner JPY, motsvararande cirka 49 miljoner SEK. 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Det [&hellip;]","og_url":"https:\/\/www.egetis.com\/sv\/pledpharma-erhaller-600-mjpy-cirka-49-msek-i-samband-med-inklusion-av-den-forsta-asiatiska-patienten-i-det-globala-fas-iii-programmet-for-pledox\/","og_site_name":"Egetis Therapeutics","article_published_time":"2019-01-10T15:06:43+00:00","author":"overlord","twitter_card":"summary_large_image","twitter_misc":{"Skriven av":"overlord","Ber\u00e4knad l\u00e4stid":"5 minuter"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.egetis.com\/sv\/pledpharma-erhaller-600-mjpy-cirka-49-msek-i-samband-med-inklusion-av-den-forsta-asiatiska-patienten-i-det-globala-fas-iii-programmet-for-pledox\/","url":"https:\/\/www.egetis.com\/sv\/pledpharma-erhaller-600-mjpy-cirka-49-msek-i-samband-med-inklusion-av-den-forsta-asiatiska-patienten-i-det-globala-fas-iii-programmet-for-pledox\/","name":"PledPharma erh\u00e5ller 600 MJPY, cirka 49 MSEK, i samband med inklusion av den f\u00f6rsta asiatiska patienten i det globala fas III-programmet f\u00f6r PledOx\u00ae - 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L\u00e4nk.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[41],"tags":[],"class_list":["post-3927","post","type-post","status-publish","format-standard","hentry","category-icke-regulatoriskt"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Japanska kliniker klara f\u00f6r patientrekrytering - Egetis Therapeutics<\/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.egetis.com\/sv\/japanska-kliniker-klara-for-patientrekrytering\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Japanska kliniker klara f\u00f6r patientrekrytering - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"(Icke regulatoriskt) PledPharmas asiatiska partner Solasia Pharma har meddelat att de japanska klinikerna st\u00e5r redo f\u00f6r patientrekrytering f\u00f6r fas III-studien POLAR. 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PledPharma AB (publ) meddelar att bolaget har l\u00e4mnat in en ans\u00f6kan till amerikanska l\u00e4kemedelsmyndigheten FDA om s\u00e4rl\u00e4kemedelsstatus (ODD, Orphan Drug Designation) f\u00f6r l\u00e4kemedelskandidaten Aladote\u00ae som utvecklas f\u00f6r att minska leverskador till f\u00f6ljd av paracetamol\u00f6verdosering.<\/p>\n<p>Dagens behandling vid \u00f6verdosering av paracetamol, N-acetylcystein (NAC), \u00e4r som effektivast om den ges inom \u00e5tta timmar efter \u00f6verdoseringen. F\u00f6r patienter som anl\u00e4nder till sjukhus senare \u00e4n s\u00e5, och f\u00f6r de patienterna med h\u00f6ga \u00f6verdoseringar, finns behov av ett mer effektivt behandlingsalternativ. Aladote\u00ae \u00e4r en \u201dfirst-in-class\u201d l\u00e4kemedelskandidat som utvecklas f\u00f6r att minska leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning.<\/p>\n<p>PledPharma bed\u00f6mer att FDA:s krav f\u00f6r s\u00e4rl\u00e4kemedelsstatus i USA kan uppfyllas, dvs att f\u00e4rre \u00e4n 200 000 personer per \u00e5r drabbas av paracetamol\u00f6verdosering och att den vetenskapliga rationalen s\u00e5v\u00e4l som de kliniska resultaten fr\u00e5n den genomf\u00f6rda proof-of-principle studien indikerar att Aladote\u00ae har potential f\u00f6r att minska leverskadorna f\u00f6r dessa patienter. Ett svar p\u00e5 ans\u00f6kan fr\u00e5n FDA bed\u00f6ms inkomma under f\u00f6rsta halv\u00e5ret 2019.<\/p>\n<p>\u201dAnledningen till v\u00e5r ans\u00f6kan beror p\u00e5 s\u00e4rl\u00e4kemedelsstatusens f\u00f6rdelar. Vid ett beviljande f\u00e5r vi sannolikt totalt l\u00e4gre utvecklingskostnader och kortare utvecklingstid. Vidare f\u00e5r vi ytterligare dedikerat st\u00f6d fr\u00e5n FDA under l\u00e4kemedelsutvecklingen och sju \u00e5rs marknadsexklusivitet efter ett marknadsgodk\u00e4nnande\u201d s\u00e4ger Nicklas Westerholm, vd, PledPharma AB.<\/p>\n<p>F\u00f6r ytterligare information, kontakta:<br \/>\nNicklas Westerholm, Verkst\u00e4llande direkt\u00f6r<br \/>\nTel. 073 354 20 62<br \/>\nnicklas.westerholm@pledpharma.se<\/p>\n<p>Yilmaz Mahshid, Finansdirekt\u00f6r<br \/>\nTel. 072 231 68 00<br \/>\nyilmaz.mahshid@pledpharma.se<\/p>\n<p><strong>Om Aladote\u00ae<\/strong><br \/>\nAladote\u00ae \u00e4r en \u201dfirst-in-class\u201d l\u00e4kemedelskandidat som utvecklas f\u00f6r att minska leverskador till f\u00f6ljd av paracetamolf\u00f6rgiftning. Aladote\u00ae har i relevanta prekliniska studier visat god effekt \u00e4ven i det tidsf\u00f6nster d\u00e4r behandling med N-acetylcystein (NAC) inte l\u00e4ngre fungerar tillfredsst\u00e4llande (&gt;8 timmar). En proof of principle studie i patienter med paracetamolf\u00f6rgiftning f\u00f6r att f\u00f6rebygga akut leversvikt har framg\u00e5ngsrikt slutf\u00f6rts.Paracetamol \u00e4r ett av det mest anv\u00e4nda l\u00e4kemedlet i v\u00e4rlden vid behandling av feber och sm\u00e4rttillst\u00e5nd, men samtidigt ett av de l\u00e4kemedel som oftast \u00f6verdoseras \u2013 avsiktligt eller oavsiktligt. Avsiktlig \u00f6verdosering av paracetamol \u00e4r en av de vanligaste metoderna vid sj\u00e4lvmordsf\u00f6rs\u00f6k. N\u00e4r alltf\u00f6r stora m\u00e4ngder paracetamol bryts ner i levern, bildas den skadliga metaboliten NAPQI, som kan orsaka akut leversvikt. Den befintliga behandlingen vid \u00f6verdosering (NAC) \u00e4r som effektivast om den ges inom \u00e5tta timmar efter intag av paracetamol. F\u00f6r patienter som anl\u00e4nder till sjukhus senare \u00e4n s\u00e5 finns idag inget v\u00e4l fungerande behandlingsalternativ.<\/p>\n<p><strong>Om Aladotes proof of principle-studie<\/strong><br \/>\nDet prim\u00e4ra syftet med studien var att utv\u00e4rdera s\u00e4kerheten och tolerabiliteten av Aladote\u00ae i kombination med dagens standardbehandling N-acetylcystein (NAC). Dessutom studerades ett flertal biomark\u00f6rer f\u00f6r leverskada. Totalt 24 patienter f\u00f6rdelades mellan tre olika dosgrupper om \u00e5tta patienter vardera. I varje dosgrupp behandlades sex patienter med en kombination av Aladote\u00ae och NAC, och tv\u00e5 patienter behandlades med enbart NAC. Studieresultaten visade att Aladote\u00ae \u00e4r s\u00e4kert och tolerabelt n\u00e4r det ges tillsammans med NAC. Resultaten indikerar ocks\u00e5 att Aladote\u00ae kan minska leverskador i den aktuella patientpopulationen. Detta baseras p\u00e5 analyser av de f\u00f6rdefinierade explorativa biomark\u00f6rerna Keratin-18 (K18) och microRNA-122 (miR-122) vilka utgjorde sekund\u00e4ra m\u00e5l i studien i en j\u00e4mf\u00f6relse mellan patienter behandlade med Aladote\u00ae i kombination med NAC och en kontrollgrupp som endast erh\u00f6ll NAC. Det uppm\u00e4ttes ingen skillnad p\u00e5 alanintransaminas (ALT) aktivitet mellan behandlingsgrupperna.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Stockholm, 24 december 2018. PledPharma AB (publ) meddelar att bolaget har l\u00e4mnat in en ans\u00f6kan till amerikanska l\u00e4kemedelsmyndigheten FDA om s\u00e4rl\u00e4kemedelsstatus (ODD, Orphan Drug Designation) f\u00f6r l\u00e4kemedelskandidaten Aladote\u00ae som utvecklas f\u00f6r att minska leverskador till f\u00f6ljd av paracetamol\u00f6verdosering. Dagens behandling vid \u00f6verdosering av paracetamol, N-acetylcystein (NAC), \u00e4r som effektivast om den ges inom \u00e5tta timmar [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-4086","post","type-post","status-publish","format-standard","hentry","category-okategoriserad"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>PledPharma har ans\u00f6kt om s\u00e4rl\u00e4kemedelsstatus (ODD) f\u00f6r Aladote i USA - Egetis Therapeutics<\/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.egetis.com\/sv\/pledpharma-har-ansokt-om-sarlakemedelsstatus-odd-for-aladote-i-usa\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PledPharma har ans\u00f6kt om s\u00e4rl\u00e4kemedelsstatus (ODD) f\u00f6r Aladote i USA - Egetis Therapeutics\" \/>\n<meta property=\"og:description\" content=\"Stockholm, 24 december 2018. 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Dagens behandling vid \u00f6verdosering av paracetamol, N-acetylcystein (NAC), \u00e4r som effektivast om den ges inom \u00e5tta timmar [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.egetis.com\/sv\/pledpharma-har-ansokt-om-sarlakemedelsstatus-odd-for-aladote-i-usa\/\" \/>\n<meta property=\"og:site_name\" content=\"Egetis Therapeutics\" \/>\n<meta property=\"article:published_time\" content=\"2018-12-24T17:29:18+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-19T17:30:33+00:00\" \/>\n<meta name=\"author\" content=\"Jakob Ivarsson\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Skriven av\" \/>\n\t<meta name=\"twitter:data1\" content=\"Jakob Ivarsson\" \/>\n\t<meta name=\"twitter:label2\" content=\"Ber\u00e4knad l\u00e4stid\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minuter\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-har-ansokt-om-sarlakemedelsstatus-odd-for-aladote-i-usa\/\",\"url\":\"https:\/\/www.egetis.com\/sv\/pledpharma-har-ansokt-om-sarlakemedelsstatus-odd-for-aladote-i-usa\/\",\"name\":\"PledPharma har ans\u00f6kt om s\u00e4rl\u00e4kemedelsstatus (ODD) f\u00f6r Aladote i USA - Egetis Therapeutics\",\"isPartOf\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/#website\"},\"datePublished\":\"2018-12-24T17:29:18+00:00\",\"dateModified\":\"2019-02-19T17:30:33+00:00\",\"author\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/e011ef98939540a4da6d3c07289f970c\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-har-ansokt-om-sarlakemedelsstatus-odd-for-aladote-i-usa\/#breadcrumb\"},\"inLanguage\":\"sv-SE\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.egetis.com\/sv\/pledpharma-har-ansokt-om-sarlakemedelsstatus-odd-for-aladote-i-usa\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.egetis.com\/sv\/pledpharma-har-ansokt-om-sarlakemedelsstatus-odd-for-aladote-i-usa\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\/\/www.egetis.com\/sv\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"PledPharma har ans\u00f6kt om s\u00e4rl\u00e4kemedelsstatus (ODD) f\u00f6r Aladote i USA\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#website\",\"url\":\"https:\/\/www.egetis.com\/sv\/\",\"name\":\"Egetis Therapeutics\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.egetis.com\/sv\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"sv-SE\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/e011ef98939540a4da6d3c07289f970c\",\"name\":\"Jakob Ivarsson\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"sv-SE\",\"@id\":\"https:\/\/www.egetis.com\/sv\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/5533c578f8531a8b79ed01ab3270d10410d2405da3934c2105cad3963de7eb62?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/5533c578f8531a8b79ed01ab3270d10410d2405da3934c2105cad3963de7eb62?s=96&d=mm&r=g\",\"caption\":\"Jakob Ivarsson\"},\"sameAs\":[\"http:\/\/www.stakeholder.se\"],\"url\":\"https:\/\/www.egetis.com\/sv\/author\/pled-jakob\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"PledPharma har ans\u00f6kt om s\u00e4rl\u00e4kemedelsstatus (ODD) f\u00f6r Aladote i USA - Egetis Therapeutics","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.egetis.com\/sv\/pledpharma-har-ansokt-om-sarlakemedelsstatus-odd-for-aladote-i-usa\/","og_locale":"sv_SE","og_type":"article","og_title":"PledPharma har ans\u00f6kt om s\u00e4rl\u00e4kemedelsstatus (ODD) f\u00f6r Aladote i USA - Egetis Therapeutics","og_description":"Stockholm, 24 december 2018. 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