NASDAQ OMX

Corline Biomedical AB: Uppdatering av status i utvecklingsprojekten

22.5.2017 14:54 | NASDAQ OMX

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Corline Biomedical AB ("Corline" eller "bolaget") kommer att hålla bolagspresentation kl 15.00 den 23 maj 2017 på Erik Penser Bank och kommer där att uppdatera investerare om status i bolagets centrala utvecklingsprojekt. Följande information kommer att diskuteras.

Bolaget bedriver två fokuserade utvecklingsprojekt - Renaparin® för att förbättra njurtransplantation och Cytoparin(TM) för att öka effekten av cellterapi till patienter med diabetes typ 1.

Renaparinprojektet är i en intensiv utvecklingsfas där förberedelser för att lämna in ansökan om klinisk prövning till Läkemedelsverket pågår. Bolaget har under april och maj 2017 hållit två möten med Läkemedelsverket angående kvalitets- och produktionsfrågeställningar (CMC) och har därefter inlett sin produktion av prövningssubstans enligt GMP tillsammans med externa leverantörer. Bolagets mål är att inleda fas 1-studier med Renaparin® under 2017 och genomföra en studie med totalt 18 patienter som rapporteras under 2018. Corline har erhållit den första av två utbetalningar från EU:s Horizon 2020-program om totalt ca 23,1 MSEK som till fullo finansierar studien.

Cytoparinprojektet är godkänt av Läkemedelsverket för start av klinisk studie, men projektstarten har senarelagts till följd av den diskussion bolaget har med Nordiska nätverket för öcellstransplantation (NPITG). Corline har erhållit ett förslag från NPITG på kortare valideringsprojekt som bedöms omfatta några månaders arbete, för att säkerställa att Cytoparin-behandlingen och skeppningen av cellmaterial mellan Oslo och Stockholm ej medför att nettonyttan av behandlingen äventyras. Parallellt med denna process har Corline inlett diskussioner med ytterligare kliniska centra både i och utanför Norden, i syfte att påskynda studiestart och patientrekrytering. Baserat på diskussioner Corline har hållit, bedömer bolaget att intresset för Cytoparin(TM) är stort hos de kliniker som bolaget diskuterar med. Målet är att addera centra till studien före den förestående semesterperioden. Parallellt fortsätter samarbetet med NPITG.

Vid frågor, vänligen kontakta

Henrik Nittmar, VD

Telefon: 018-71 30 90

E-post: henrik.nittmar@corline.se

Certified Adviser

Sedermera Fondkommission är Corlines Certified Adviser.

Denna information är sådan information som Corline Biomedical AB är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 22 maj 2017.

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.




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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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