DK2683397T3 - Faktor xii inhibitorer til administration til medicinske procedurer omfattende kontakt med kunstige overflader - Google Patents

Faktor xii inhibitorer til administration til medicinske procedurer omfattende kontakt med kunstige overflader Download PDF

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DK2683397T3
DK2683397T3 DK12707782.4T DK12707782T DK2683397T3 DK 2683397 T3 DK2683397 T3 DK 2683397T3 DK 12707782 T DK12707782 T DK 12707782T DK 2683397 T3 DK2683397 T3 DK 2683397T3
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fxii
inhibitor
fxiia
blood
sequence
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DK12707782.4T
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Ingo Pragst
Stefan Schulte
Stefan Zeitler
Marc Nolte
Gerhard Dickneite
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Csl Behring Gmbh
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Claims (19)

1. inhibitor af FXII/FXila ti! anvendelse tii forebyggelse af dannelsen og/eller stabiliseringen af blodpropper under og/elier efter en medicinsk procedure udført på et menneske- eller dyreindivid omfattende at bringe blod fra nævnte menneske- eller dyreindivid i kontakt med kunstige overflader, hvor nævnte inhibitor af FXII/FXila er administreret før og/elier under og/eller efter den medicinske procedure og yderligere hvor (i) den kunstige overflade er udsat for mindst 80% af individets blodvolumen, og den kunstige overflade er mindst 0,2 m2eller (ii) den kunstige overflade er en beholder tii opsamling af biod uden for individet eller (iii) den kunstige overflade er en stent, klap, intraluminal kateter eller et system til indre assisteret pumpning af biod, hvor FXII/FXIla-inhibitoren omfatter (i) vildtype-lnfestin-4-polypeptidsekvensen (SEQ ID NO: 1) eller en variant deraf, hvor en variant omfatter (a) de N-terminale aminosyrer 2-13 af vi Idty pe-1 nf esti n-4-sekvensen og mindst en og op til fem aminosyremutationer uden for nævnte N-terminale aminosyrer der resulterer i forskelle fra vildtype-lnfestin-4-sekvensen ; og/eller (b) seks konserverede cystein rester fra vi idty pe-1 nf esti n-4-sekvensen og en homologi på mindst 70% til viid-type-infestin-4-sekvensen (ii) SPINK-1 (SEQ ID NO: 2), som er muteret til at inkludere de N- terminale aminosyrer 2-13 af vildtype-!nfestin-4-sekvensen eller en variant af nævnte muterede SPINK-1, hvor en variant omfatter (a) de N-terminale aminosyrer 2-13 af vildtype-lnfestin-4-sekvensen; og mindst en og op til fem aminosyremutationer uden for nævnte N-terminale aminosyrer, der resulterer i forskelle fra vildtype-SPINK-1 -sekvensen og som forøger variantens homologi til vildtype-infestin-4-sekvensen; og/eller (b) seks konserverede cysteinrester fra vildtype-SPINK-1 -sekvensen og en homologi på mindst 70% til vildtype-SPINK-1-sekvensen (lii) et anti-FXII/FXIla-antistof, hvor antistoffet binder ti! FXil/FXlia og inhiberer dens aktivitet og/eller aktivering.
2. Inhibitor af FXII/FXIIa ti! anvendelse ifølge krav 1, hvor nævnte menneskeeller dyreindivid har en blødningsrisiko som ikke er forøget og som er bestemt a) ved hjælp af øret eller fingerspids blødningstiden ifølge Duke og hvor nævnte øre- eller fingerspids blødningstid ikke er længere end 10 minutter eller b) ifølge Ivy-metoden og hvor blødningstiden ikke er længere end 10 minutter eller c) ifølge Marx-metoden og blødningstiden er ikke længere end 4 minutter.
3. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 1 og 2, hvor den medicinske procedure er i) enhver procedure der kræver en kardiopulmonal bypass eller ii) iltningen og pumpningen af blod via ekstrakorporeal membran iltning eller iii) den assisterede pumpning af blod (indre eller ydre) eller iv) dialysen af blod eller v) den ekstrakorporea! filtrering af blod eller vi) opsamiingen af blod i et hvert depot til senere brug i et dyre- eller et menneskeindivid eiier vil) anvendeisen af venøse eller arterieiie intraluminal(e) kateter(er) eller viii) anvendelsen af enhed(er) til diagnostisk eller interventionel hjertekatete ri se ring eller ix) anvendelsen af intravaskulær(e) enhed(er) eller x) anvendelsen af kunstig(e) hjerteklap(per) eller xi) anvendelsen af kunstig(e) transplantat(er).
4. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 1 til 3, hvor inhibitoren af FXII/FXila er administreret før, efter og/eller under en medicinsk procedure der kræver kardiopuimonal bypass.
5. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 1 til 3, hvor inhibitoren af FXII/FXIIa er administreret før, efter og/eller under en medicinsk procedure omfattende opsamlingen af blod i et hvert depot til senere anvendelse i et dyre- eller menneskeindivid.
6. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 5, hvor inhibitoren er: i) administreret til bloddonoren før og/eller under bloddonationsprocessen eller il) blandet med blodet i opsamlingsdepotet eller iii) administreret til biodrecipienten før, under og/eller efter at blodet er administreret til menneske- eller dyrerecipienten.
7. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 1 ti! 6, hvor FXII/FXIIa inhibitoren er administreret ved at blive coatet på den kunstige overflade.
8. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 1 til 7, hvorved en reduceret mængde heparin eller derivater deraf og/eller hirudin eller derivater deraf er tilsat ud over FXII/FXIla-inhibitoren før og/eSler under og/elier efter den medicinske procedure, sammenlignet med mængden af heparin eller derivater deraf og/eller hirudin eller derivater deraf der normalt er administreret før og/eller under nævnte medicinske procedure når der ikke er administreret inhibitor af FXII/FXI la.
9. Inhibitor af FXM/FXIIa til anvendelse ifølge krav 1 til 8, hvor ingen heparin eller et derivat deraf og/eller ingen hirudin eller et derivat deraf er anvendt ud over inhibitoren af FXII/FXI la.
10. Inhibitor af FXM/FXIIa til anvendelse ifølge krav 1 til 9, hvor nævnte menneske- eller dyreindivid har en reduceret eller ingen protrombotisk risiko efter den medicinske procedure.
11. Inhibitor af FXII/FXI la til anvendelse ifølge krav 1 ti! 10, hvor nævnte menneske- eller dyreindivid har en reduceret eller ingen protrombotisk risiko efter en postoperativ antagonisme af heparin eller derivater deraf og/eller en postoperativ antagonisme af hirudin eller derivater deraf, og eventuelt hvor den protrombotiske risiko skyldes administration af protamin.
12. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 1 til 11, hvor en reduceret mængde af eller ingen heparin-antagonist og/eller hirudin-antagonist ti! nævnte menneske- eller dyreindivid er tilsat efter den medicinske procedure sammenlignet med mængden af nævnte antagonist der normalt er administreret efter nævnte medicinske procedure når der ikke er administreret inhibitor af FXII/FXIIa.
13. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 1 til 12 til forebyggelsen eller behandlingen af postperfusions syndrom.
14. Inhibitor af FXII/FXIIa ti! anvendelse ifølge krav 1 ti! 13, hvor FXII/FXIIa- inhibitoren omfatter SPINK K1, K2 eller K3 (SEQ ID NO: 3, 4 eller 5).
15. Inhibitor af FXII/FXIIa ti! anvendelse ifølge krav 1 ti! 14, hvor FXII/FXIIa- inhibitoren er bundet tii et halveringstidsforøgende-polypeptid, hvor det halve-ringstidsforøgende-peptid eventuelt er albumin, afamin, alfa-fetøprotein eller vitamin-D-bindende protein, humant albumin eller en variant deraf, et immunoglobulin eller en variant deraf, en Fc af en IgG.
16. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 15, hvor det halvedngstids-frorøgende-polypeptid er bundet til FXII / FXIla-inhibitoren via en linker.
17. Inhibitor af FXII/FXIIa til anvendelse ifølge krav 16, hvor linkeren er mindst en af: (i) spaltelig; (ii) spaltelig af en koagulationsprotease af den indre, ydre eller generelle koagulationsvej; og (iii) spaltelig af FXI la.
18. Inhibitor af FXII/FXIIa som defineret i krav 1 til 17 til anvendelse til at forhindre blokeringen af humant blodgennemstrøm i en ekstrakorporeal medicinsk enhed, hvor den medicinske enhed eventuelt er en kardiopuimonal by-pass-enhed eller en enhed anvendt til dialyse af blod eller ekstrakorporeale filtrering af blod.
19. Medicinsk enhed belagt med en inhibitor af FXII/FXIIa som defineret i krav 1 til 18, hvor enheden er en kardiopuimonal bypass-maskine, et ekstrakorpo-ralt-membran-iltnings-system til iltning af blod, en enhed til assisteret pumpning af blod, en bioddialyseenhed, en enhed til ekstrakorporeal filtrering af blod, et depot tii anvendelse i blodopsamlingen, et intraluminalt kateter, en stent, en kunstig hjerteklap og/elier tilbehør til en hvilken som helst af de nævnte enheder, herunder slange, kanyle, centrifugalpumpe, klap, port og / eller omleder.
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