DK2948479T3 - Evaluering og behandling af bradykininmedierede forstyrrelser - Google Patents

Evaluering og behandling af bradykininmedierede forstyrrelser Download PDF

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DK2948479T3
DK2948479T3 DK14740444.6T DK14740444T DK2948479T3 DK 2948479 T3 DK2948479 T3 DK 2948479T3 DK 14740444 T DK14740444 T DK 14740444T DK 2948479 T3 DK2948479 T3 DK 2948479T3
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hmwk
pkal
cleaved
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disease
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Daniel J Sexton
Ryan Faucette
Jon A Kenniston
Andrew Nixon
Christopher Tenhoor
Burt Adelman
Yung Chyung
Greg Conley
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Dyax Corp
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/573—Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
    • G01N33/5735—Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes co-enzymes or co-factors, e.g. NAD, ATP
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    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/745—Assays involving non-enzymic blood coagulation factors
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    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/914—Hydrolases (3)
    • G01N2333/948—Hydrolases (3) acting on peptide bonds (3.4)
    • G01N2333/95—Proteinases, i.e. endopeptidases (3.4.21-3.4.99)
    • G01N2333/964—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue
    • G01N2333/96425—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals
    • G01N2333/96427—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals in general
    • G01N2333/9643—Proteinases, i.e. endopeptidases (3.4.21-3.4.99) derived from animal tissue from mammals in general with EC number
    • G01N2333/96433—Serine endopeptidases (3.4.21)
    • G01N2333/96441—Serine endopeptidases (3.4.21) with definite EC number
    • G01N2333/96455—Kallikrein (3.4.21.34; 3.4.21.35)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N2800/101—Diffuse connective tissue disease, e.g. Sjögren, Wegener's granulomatosis
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Claims (13)

1. Fremgangsmåde til identificering af et individ, der har risiko for at få eller har en plasmakallikrein (pKal)-medieret forstyrrelse, hvilken fremgangsmåde omfatter: måling af et niveau af et spaltet højmolekylært kininogen (HMWK) og eventuelt et niveau af et intakt HMWK i en prøve fra et individ; bestemmelse af en værdi af det spaltede HMWK; og identificering af, at individet har risiko for at få eller har en pKal-medieret forstyrrelse, hvis værdien af det spaltede HMWK er over en referenceværdi, hvor referenceværdien henviser til værdien af spaltet HMWK hos et rask individ; og hvor den pKal-medierede forstyrrelse er hereditært angioødem (HAE), rheumatoid arthritis, ulcerativ colitis eller Crohns sygdom.
2. Fremgangsmåde ifølge krav 1, hvor værdien af det spaltede HMWK er procentdelen af det spaltede HMWK i prøven.
3. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 2, hvor niveauerne af det spaltede HMWK og eventuelt intakte HMWK måles ved hjælp af et detektionsmiddel, der binder specifikt til spaltet HMWK sammenlignet med intakt HMWK eller binder specifikt til intakt HMWK sammenlignet med spaltet HMWK, hvor eventuelt detektionsmidlet ikke binder til lavmolekylært kininogen (LMWK).
4. Fremgangsmåde ifølge krav 3, hvor detektionsmidlet er et antistof; fortrinsvis hvor antistoffet binder specifikt til spaltet HMWK sammenlignet med intakt HMWK og eventuelt ikke binder til LMWK, mere fortrinsvis hvor detektionsmidlet er et antistof, der binder til C-terminalen af den lette kæde af spaltet HMWK.
5. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 4, hvor niveauerne af intakt HMWK og spaltet HMWK måles ved hjælp af Western-blotanalyse.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 5, hvor prøven er en blodprøve eller en plasmaprøve.
7. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 6, hvor individet har et symptom på den pKal-medierede forstyrrelse; eller hvor individet er resistent over for antihistaminbehandling, kortikosteroidbehandling eller begge.
8. Fremgangsmåde ifølge krav 7, hvor symptomet er ødem.
9. Fremgangsmåde ifølge krav 7, hvor symptomet er: tilbagevendende tilfælde af hævelse; hævelse, hvor hævelsen er fuldstændig eller overvejende perifer; nældefeber; rødme, smerter og hævelse uden tegn på infektion; eller ikke-histaminmedieret ødem.
10. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 9, hvor individet ikke har noget symptom på den pKal-medierede forstyrrelse på tidspunktet, hvor prøven tages, ikke tidligere har haft et symptom på den pKal-medierede forstyrrelse eller ikke tidligere har haft den pKal-medierede forstyrrelse.
11. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, der yderligere omfatter bestemmelse af, om forstyrrelse er modtagelig for behandling med en pKal-inhibitor, hvor forstyrrelsen er modtagelig for behandling med en pKal- inhibitor, hvis værdien af spaltet HMWK er over referenceværdien.
12. Fremgangsmåde til evaluering af en behandling af en pKal-medieret forstyrrelse hos et individ, hvilken fremgangsmåde omfatter: måling af niveauerne af spaltet HMWK og eventuelt niveauerne af intakt HMWK i prøver taget fra individet før og efter behandlingen eller i løbet af behandlingen; bestemmelse af en værdi af spaltet HMWK i hver prøve på baggrund af niveauerne af spaltet og eventuelt intakt HMWK i den samme prøve; og evaluering af virkningen af behandlingen på baggrund af ændringer i værdierne af spaltet HMWK i prøverne før og efter behandlingen eller i løbet af behandlingen, hvor den pKal-medieret forstyrrelse er hereditært angioødem (HAE), rheumatoid arthritis, ulcerativ colitis eller Crohns sygdom.
13. Farmaceutisk sammensætning til anvendelse til behandling af en pKal-medieret sygdom hos et individ, hvilken sammensætning omfatter en pKal-inhibitor og et farmaceutisk acceptabelt bæremateriale, hvor individet har en værdi af spaltet højmolekylært kininogen (HMWK), der er over en referenceværdi, som henviser til værdien af spaltet HMWK hos et rask individ; og hvor den pKal-medierede sygdom er hereditært angioødem (HAE), rheumatoid arthritis, ulcerativ colitis eller Crohns sygdom.
DK14740444.6T 2013-01-20 2014-01-17 Evaluering og behandling af bradykininmedierede forstyrrelser DK2948479T3 (da)

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US201361754607P 2013-01-20 2013-01-20
PCT/US2014/012107 WO2014113712A1 (en) 2013-01-20 2014-01-17 Evaluation and treatment of bradykinin-mediated disorders

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JP (4) JP6444315B2 (da)
KR (3) KR102203880B1 (da)
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AU (4) AU2014207420B2 (da)
CA (2) CA2897336C (da)
CY (1) CY1122164T1 (da)
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