{"id":4025,"date":"2020-12-10T13:30:00","date_gmt":"2020-12-10T13:30:00","guid":{"rendered":"https:\/\/www.nanexa.com\/mfn_news\/nanexa-erhaller-kliniskt-provningstillstand-for-nex-18\/"},"modified":"2020-12-10T13:30:00","modified_gmt":"2020-12-10T13:30:00","slug":"nanexa-erhaller-kliniskt-provningstillstand-for-nex-18","status":"publish","type":"mfn_news","link":"https:\/\/nanexa.com\/sv\/mfn_news\/nanexa-erhaller-kliniskt-provningstillstand-for-nex-18\/","title":{"rendered":"Nanexa erh\u00e5ller kliniskt pr\u00f6vningstillst\u00e5nd f\u00f6r NEX-18"},"content":{"rendered":"
\n

Nanexa AB (publ) meddelar idag att bolaget f\u00e5tt tillst\u00e5nd att starta klinisk pr\u00f6vning av l\u00e4kemedelskandidaten NEX-18 av L\u00e4kemedelsverket.<\/strong><\/p>\n<\/div>\n

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\u201dTillst\u00e5ndet \u00e4r en stor och viktig milstolpe f\u00f6r Nanexa d\u00e5 det \u00e4r den f\u00f6rsta kliniska studien med ett l\u00e4kemedel baserat p\u00e5 PharmaShell\u00ae. Godk\u00e4nnandet inneb\u00e4r att vi nu kan starta NEX-18-studien enligt utsatt tidplan och det \u00e4r en kvalitetsst\u00e4mpel som visar att vi har gjort r\u00e4tt saker p\u00e5 v\u00e4gen mot att bli ett riktigt l\u00e4kemedelsbolag\u201d, s\u00e4ger David Westberg, vd p\u00e5 Nanexa.<\/p>\n

NEX-18-produkten utvecklas f\u00f6r att f\u00f6rb\u00e4ttra behandlingen av MDS (Myelodysplastiskt syndrom), en form av leukemi som framf\u00f6rallt drabbar \u00e4ldre personer. Det g\u00f6rs genom att utnyttja PharmShell\u00ae-konceptets unika egenskaper f\u00f6r att skapa en egen dep\u00e5beredning med styrd fris\u00e4ttning. I dagens behandling ges injektioner p\u00e5 sjukhus sju dagar i rad varje m\u00e5nad och m\u00e5let med NEX-18-projektet \u00e4r att f\u00f6renkla behandlingen genom att endast beh\u00f6va ge en injektion. F\u00f6rutom att kraftigt f\u00f6renkla f\u00f6r patienterna r\u00e4knar bolaget med att NEX-18 \u00e4ven kommer att minska kostnaderna f\u00f6rknippade med dagens behandling. Studien, som \u00e4r en s k PK-studie (fas I), kommer att genomf\u00f6ras vid Karolinska Universitetssjukhuset i Stockholm och Akademiska Sjukhuset i Uppsala.<\/p>\n

\u201dMed detta besked i ryggen kommer vi nu intensifiera f\u00f6rberedelserna p\u00e5 klinikerna f\u00f6r att komma ig\u00e5ng med rekryteringen av patienter s\u00e5 snart som m\u00f6jligt. Inklusionen av \u00e4ldre, sk\u00f6ra leukemipatienter kan vara sv\u00e5rare \u00e4n normalt i dessa pandemitider, men med tv\u00e5 kliniker involverade minimerar vi den risken. Vi r\u00e4knar med att avsluta studien i tredje kvartalet n\u00e4sta \u00e5r\u201d, s\u00e4ger David Westberg.
\u00a0<\/p>\n<\/div>\n

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F\u00f6r mer information kontakta:<\/strong><\/p>\n

\n

David Westberg \u2013 VD, Nanexa AB (publ)\u00a0
Telefon: 0709-42 83 03
E-post:\u00a0david.westberg@nanexa.se<\/a>
www.nanexa.com<\/a><\/p>\n

Erik Penser Bank \u00e4r bolagets Certified Adviser och n\u00e5s p\u00e5 08-463 83 00, e-post: certifiedadviser@penser.se<\/p>\n<\/div>\n

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Om Nanexa AB (publ)<\/strong><\/p>\n

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Nanexa AB \u00e4r ett nanoteknologiskt drug delivery-f\u00f6retag fokuserat p\u00e5 utvecklingen av PharmaShell\u00ae, ett nytt och banbrytande drug delivery-system med stor\u00a0potential inom ett flertal substanstyper och indikationsomr\u00e5den. Inom ramen f\u00f6r PharmaShell\u00ae utvecklar Nanexa egna projekt och har samarbetsavtal med flera l\u00e4kemedelsbolag, d\u00e4ribland\u00a0AstraZeneca.<\/p>\n<\/div>\n

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Bifogade filer<\/strong><\/p>\n

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Nanexa erh\u00e5ller kliniskt pr\u00f6vningstillst\u00e5nd f\u00f6r NEX-18<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Nanexa AB (publ) meddelar idag att bolaget f\u00e5tt tillst\u00e5nd att starta klinisk pr\u00f6vning av l\u00e4kemedelskandidaten NEX-18 av L\u00e4kemedelsverket.<\/p>\n","protected":false},"template":"","class_list":["post-4025","mfn_news","type-mfn_news","status-publish","hentry","mfn-news-tag-mfn-ci_sv","mfn-news-tag-mfn-type-ir_sv","mfn-news-tag-mfn_sv","mfn-news-tag-mfn-ci-other_sv","mfn-news-tag-mfn-lang-sv_sv"],"acf":[],"yoast_head":"\nNanexa erh\u00e5ller kliniskt pr\u00f6vningstillst\u00e5nd f\u00f6r NEX-18 - Nanexa AB<\/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:\/\/nanexa.com\/mfn_news\/nanexa-erhaller-kliniskt-provningstillstand-for-nex-18\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanexa erh\u00e5ller kliniskt pr\u00f6vningstillst\u00e5nd f\u00f6r NEX-18 - 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