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Corline Biomedical AB: Etikprövningsnämnden ger godkännande till klinisk studie för Cytoparin

12.5.2016 12:08 | NASDAQ OMX

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Corline Biomedical AB ("Corline") meddelar att den Regionala Etikprövningsnämnden i Uppsala på sitt möte den 4 maj 2016 beslutat godkänna begäran om ändring som inlämnats i den sedan tidigare godkända Cytoparin -studien, där Corline är sponsor och Tomas Lorant vid Akademiska sjukhuset är prövningsledare. Beslutet har publicerats på Etikprövningsnämndens hemsidan (www.epn.se).

Corline har sedan tidigare Läkemedelsverkets och Etikprövningsnämndens godkännande att starta en klinisk prövning med Cytoparin(TM) som medicinteknisk produkt. För att ansluta projektet till det nu gällande regelverket om cellbaserade produkter (avancerande terapiläkemedel, ATMP) och därigenom effektivisera utvecklingsprocessen, beslutade Corline 2015 om att lämna in en ny ansökan för att pröva Cytoparin(TM) som läkemedel. Etikprövningsnämnden i Uppsala har nu godkänt de begärda ändringarna för den kliniska studiens upplägg. Innan Corline kan starta studien återstår att erhålla Läkemedelsverkets godkännande. 

Cytoparin(TM)-studien görs i samarbete med Akademiska sjukhuset, Rikshospitalet i Oslo och Karolinska sjukhuset i Huddinge och syftar till att pröva om det är säkert och effektivt att använda Cytoparin(TM) för att skydda insulinproducerande celler vid transplantation till svårt sjuka patienter med diabetes typ 1. Idag upphör funktionen i upp till 70 % av de transplanterade cellerna inom den första timmen efter transplantation, eftersom cellerna angrips av mottagarens immunförsvar. Det gör att sjukvården i genomsnitt måste använda 2,7 donatorer för att behandla 1 patient. En transplantation kostar ungefär 800 000 kronor att genomföra och det råder en mycket stor brist på organ för transplantation. Genom att klä in cellerna med Cytoparin(TM) inför transplantationen är målet att cellerna skyddas och bibehåller sin funktion samt att användandet av organ därmed effektiviseras . Härigenom kan betydligt fler svårt sjuka patienter med diabetes typ 1 erbjudas behandling.

Henrik Nittmar, VD i Corline Biomedical AB, kommenterar
"Etikprövningsnämndens godkännande innebär ett viktigt steg på vägen mot studiestart i Cytoparin(TM)-projektet. Nu inväntar vi svar från Läkemedelsverket på vår ansökan om prövning som läkemedel."

Certified Adviser
Sedermera Fondkommission är Corlines Certified Adviser.

För mer information om Corline, vänligen kontakta
Henrik Nittmar, VD
Telefon: 018-71 30 90
E-post: henrik.nittmar@corline.se

Corline Biomedical AB arbetar med den kroppsegna substansen heparin och har utvecklat en portfölj med läkemedelskandidater för användning i anslutning till organ- och celltransplantation. Bolaget planerar kliniska studier inom diabetes typ 1 och njurtransplantation, för vilket Corline även har erhållit särläkemedelsstatus ("Orphan Drug"). Inom ramen för helägda dotterbolaget Corline Pharma AB utvärderas in vivo-administration av Corlines heparinsubstans och sedan tidigare ytbelägger bolaget medicintekniska produkter och har bland annat behandlat över 100 000 hjärtstentar som implanterats i patienter. De nya läkemedelskandidaterna är baserade på samma grundteknologi som de medicintekniska produkterna.




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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Corline Biomedical AB via Globenewswire

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