DK2545380T3 - HMGB1- og anti-HMGB1-antistoffer til prognose af neurologiske lidelser - Google Patents

HMGB1- og anti-HMGB1-antistoffer til prognose af neurologiske lidelser Download PDF

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DK2545380T3
DK2545380T3 DK11710151.9T DK11710151T DK2545380T3 DK 2545380 T3 DK2545380 T3 DK 2545380T3 DK 11710151 T DK11710151 T DK 11710151T DK 2545380 T3 DK2545380 T3 DK 2545380T3
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hiv
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neurological disorders
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Marie-Lise Gougeon
Béatrice Poirier-Beaudoin
Valérie Seffer
Héla Saidi
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Pasteur Institut
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Claims (16)

1. Prognostisk fremgangsmåde in vitro for enten udviklingsstadiet af neurologiske lidelser eller udviklingsstadiet hen imod neurologiske lidelser i en patient, omfattende: a) at en cerebrospinalvæskeprøve eller en serumprøve eller både en serumprøve og en cerebrospinalvæskeprøve, der er opnået fra patienten, bringes i kontakt med nativt HMGB1-protein eller HMGB1-proteinderivater, så længe disse derivater bindes til for HMGB1 specifikke antistoffer; og b) at de i cerebrospinalvæskeprøven, serumprøven eller både serumprøven og cerebrospinalvæskeprøven indeholdte for High Mobility Group Box I (HMGB1) specifikke antistoffer mængdebestemmes; idet et højere niveau af for HMGB1 specifikke antistoffer betyder større risiko for at udvikle neurologiske lidelser eller for at udvikle et fremskredent stadium af neurologiske lidelser.
2. Prognostisk fremgangsmåde in vitro for enten udviklingsstadiet af neurologiske lidelser eller udviklingsstadiet hen imod neurologiske lidelser ifølge krav 1, omfattende endvidere mængdebestemmelse af chemokin IP-10 og/eller chemokin MCP-1 i prøven, især en serumprøve eller en cerebrospinalvæskeprøve eller i både serumprøven og cerebrospinalvæskeprøven, der er opnået fra patienten, idet et højere niveau af for HMG B1 specifikke antistoffer og mere chemokin IP-10 og/eller mere chemokin MCP-1 betyder højere risiko for at udvikle neurologiske lidelser eller for at udvikle et fremskredent stadium af neurologiske lidelser.
3. Prognostisk fremgangsmåde in vitro ifølge krav 1 eller 2, ved hvilken de neurologiske lidelser står i forbindelse med en sygdom eller lidelse, som er valgt fra gruppen bestående af (1) sygdomme eller lidelser af infektiøs oprindelse, f.eks. bakterieinfektion, pathogeninfektion, virusinfektion eller prioninfektion, såsom HIV-infektion; og (2) sygdomme eller lidelser, hvis oprindelse er ikke-infektiøs, eller hvis oprindelse er ukendt, f.eks. akut neuronal læsion, traumatisk hjernelæsion, Alzheimers sygdom, Huntingtons sygdom, postikæmisk hjernelæsion, Parkinsons sygdom, en vilkårlig lidelse, der rammer det perifere nervesystem og/eller rygmarven, såsom rygmarvslæsion, amyotrof lateral sclerose og demyelinerende sygdomme, såsom dissemineret sclerose (MS).
4. Prognostisk fremgangsmåde in vitro ifølge et hvilket som helst af kravene 1 til 3, som endvidere omfatter (a) at identificere volumetriske ændringer i patientens basalganglier, fortrinsvis ved magnetresonansbilleddannelsesmålinger; og/eller (b) at identificere stofskifteændringer i patientens basalganglier, fortrinsvis ved at beregne forholdet mellem cholin og N-acetylaspartat (Cho/NAA) i serum.
5. Prognostisk fremgangsmåde in vitro ifølge et hvilket som helst af kravene 1 til 4, ved hvilken de neurologiske lidelser står i forbindelse med HIV-infektion i en med HIV inficeret patient.
6. Prognostisk fremgangsmåde in vitro ifølge et hvilket som helst af kravene 1 til 5, ved hvilken de neurologiske lidelser står i forbindelse med HIV-infektion i en patient, der er inficeret med HIV og er under retroviral terapi.
7. Diagnostisk fremgangsmåde in vitro for tilstedeværelsen af neurologiske lidelser i en patient, omfattende: (a) at bedømme tilstedeværelsen eller fraværet af neurologiske lidelser ved traditionelle kliniske kriterier; og (b) at mængdebestemme de i en cerebrospinalvæskeprøve, en serumprøve eller både en serumprøve og en cerebrospinalvæskeprøve, der er opnået fra patienten, indeholdte for High Mobility Group Box I (HMGB1) specifikke antistoffer, efter at prøven er bragt i kontakt med nativt HMGB1-protein eller HMGB1-proteinderivater, så længe disse derivater bindes til for HMGB1 specifikke antistoffer; idet niveauet af for HMGB1 specifikke antistoffer korrelerer med diagnosen for tilstedeværelsen af neurologiske lidelser ved traditionelle kliniske kriterier.
8. Fremgangsmåde in vitro ifølge krav 7, som endvidere omfatter mængdebestemmelse af andre molekyler, der findes i prøven, såsom chemokiner, og fortrinsvis mængdebestemmelse af chemokin IP-10 og/eller chemokin MCP-1.
9. Fremgangsmåde in vitro ifølge krav 7 eller 8, ved hvilken de neurologiske lidelser står i forbindelse med AIDS i en HIV-inficieret patient.
10. Fremgangsmåde in vitro ifølge et hvilket som helst af kravene 1 til 9, som omfatter et trin, inden prøven bringes i kontakt med nativt HMGB1-protein eller HMGB1-proteinderivater, så længe disse derivater bindes til for HMGB1 specifikke antistoffer, til behandling af prøven ved en syrebehandling for at dissociere de immunkomplekser, der findes i prøven, fortrinsvis med 1,5 M glycin ved lavt pH, og idet de mængdebestemte for High Mobility Group Box I (HMGB1) specifikke antistoffer ved den fremgangsmåde angår den samlede mængde for HMGB1 specifikke antistoffer.
11. Fremgangsmåde in vitro ifølge et hvilket som helst af kravene 1 til 10, ved hvilken de mængdebestemte for High Mobility Group Box I (HMGB1) specifikke antistoffer er den cirkulerende fraktion af antistofferne (cirkulerende antistoffer) eller den immunologisk kompleksbundne fraktion af dem.
12. Fremgangsmåde in vitro ifølge et hvilket som helst af kravene 1 til 11, ved hvilken HMGB1-proteinderivatet er valgt fra gruppen bestående af en rekombinant HMGB1, en immunologisk reaktionsdygtig del af HMGB1, en immunologisk reaktionsdygtig del af HMGB1, hvis sekvens er fælles for HMGB1-proteiner af forskellige oprindelser, og den rekombinante BOXB fra HMGB1 svarende til den sekvens, der er fælles for human og murin HMGB1.
13. Anvendelse af et sæt til at udføre prognosen for enten udviklingsstadiet af neurologiske lidelser i en patient eller udviklingsstadiet hen imod neurologiske lidelser i en patient, hvor sættet omfatter: a) nativt HMGB1-protein eller HMGB1-proteinderivater, så længe disse derivater bindes til for HMGB1 specifikke antistoffer; b) eventuelt en sur dissociationsopløsning, der har en pH-værdi mellem 1 og 3 til at dissociere immunologiske HMGB1/anti-HMGB1-antistofkomplekser, der findes i den biologiske prøve, når den tages fra patienten, uden at ændre anti-HMGB1-antistoffets bindingsevne; c) eventuelt midler til at mængdebestemme chemokiner; d) eventuelt en neutraliseringspuffer; e) eventuelt sekundære antistoffer, der binder sig til komplekset af HMGB1 og specifikke antistoffer; og f) eventuelt en brugsanvisning, især en indlægsseddel.
14. Anvendelse af et sæt ifølge krav 13, hvor sættet omfatter: a) nativt HMGB1-protein eller de nævnte HMGB1-proteinderivater; og b) den sure dissociationsopløsning.
15. Anvendelse af et sæt ifølge krav 13, hvor sættet omfatter: a) nativt HMGB1-protein eller de nævnte HMGB1-proteinderivater; og b) midler til mængdebestemmelse af chemokiner.
16. Anvendelse af et sæt ifølge krav 13 eller 15, ved hvilken chemokinet er chemokin IP-10 og/eller chemokin MCP-1.
DK11710151.9T 2010-03-10 2011-03-10 HMGB1- og anti-HMGB1-antistoffer til prognose af neurologiske lidelser DK2545380T3 (da)

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EP10290124.6A EP2365332B1 (en) 2010-03-10 2010-03-10 HMGB1 and anti-HMGB1 antibodies in HIV infected patients especially with neurological disorders
PCT/EP2011/053656 WO2011110650A2 (en) 2010-03-10 2011-03-10 Hmgb1 and anti-hmgb1 antibodies for the prognostic of neurological disorders

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US (3) US8728748B2 (da)
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JP (3) JP5703314B2 (da)
KR (1) KR101972602B1 (da)
CN (1) CN102884432B (da)
CA (2) CA2944657C (da)
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