DK2596010T3 - Signalbiomarkører - Google Patents

Signalbiomarkører Download PDF

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Publication number
DK2596010T3
DK2596010T3 DK11810311.8T DK11810311T DK2596010T3 DK 2596010 T3 DK2596010 T3 DK 2596010T3 DK 11810311 T DK11810311 T DK 11810311T DK 2596010 T3 DK2596010 T3 DK 2596010T3
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cnpsp
fragment
level
eposp
antibody
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DK11810311.8T
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Christopher Joseph Pemberton
Arthur Mark Richards
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Otago Innovation Ltd
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • G01N33/746Erythropoetin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K7/00Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04Linear peptides containing only normal peptide links
    • C07K7/06Linear peptides containing only normal peptide links having 5 to 11 amino acids
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K7/00Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04Linear peptides containing only normal peptide links
    • C07K7/08Linear peptides containing only normal peptide links having 12 to 20 amino acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/475Assays involving growth factors
    • G01N2333/505Erythropoietin [EPO]
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575Hormones
    • G01N2333/58Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/32Cardiovascular disorders
    • G01N2800/324Coronary artery diseases, e.g. angina pectoris, myocardial infarction
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/32Cardiovascular disorders
    • G01N2800/325Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/34Genitourinary disorders
    • G01N2800/347Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (15)

1. Fremgangsmåde til forudsigelse, diagnosticering eller monitorering af en hjerteforstyrrelse hos en person udvalgt fra gruppen bestående af akut koronart syndrom, indbefattende akut myokardieinfarkt (AMI) og angina, hjerteinsufficiens, vulnerable plaques og karsygdom, indbefattende atherosklerose, eller til forudsigelse, diagnosticering eller monitorering af en akut og/eller kronisk nyresygdom, -læsion eller -forstyrrelse hos en person, hvilken fremgangsmåde omfatter: (a) måling af niveauet af CNPsp-fragmentet ifølge SEQ ID NO: 6 i en biologisk prøve fra personen; og (b) sammenligning af niveauet af CNPsp-fragmentet med niveauet fra en kontrol, hvor et målt niveau af CNPsp-fragmentet, der er større end kontrolniveauet, indikerer hjerteforstyrrelsen eller nyresygdommen, -læsionen eller -forstyrrelsen.
2. Fremgangsmåde ifølge krav 1, hvor fremgangsmåden anvendes til at evaluere eller monitorere et respons på behandling af en akut eller kronisk hj erteforstyrrelse hos en person, eller til at evaluere eller monitorere et respons på behandling af en akut eller kronisk nyresygdom eller -forstyrrelse hos en person, hvor en ændring i det målte niveau af CNPsp-fragmentet i forhold til kontrolniveauet indikerer et respons på behandlingen.
3. Fremgangsmåde ifølge krav 1, hvilken fremgangsmåde omfatter: (i) måling af niveauet af CNPsp-fragmentet i en biologisk prøve fra personen inden for de første 48 timer, 24 timer, 12 timer, seks timer, fire timer, to timer, én time eller 30 minutter efter indtræden af, eller klinisk præsentation med hjerteforstyrrelsen eller nyreforstyrrelsen eller -sygdommen.
4. Fremgangsmåde ifølge krav 1 eller 3, hvor: (i) et niveau af CNPsp-fragmentet deraf i prøven inden for intervallet 40 til 250 pmol/L, 65 til 200 pmol/L, 70 til 150 eller 70 til 130 pmoFL, indikerer et AKS; og/eller (ii) et niveau af CNPsp-fragmentet deraf i prøven der er 1,5 til 10, 1,5 til 5, eller 2 til 3 gange større end kontrolniveauet, indikerer indtræden af et AKS; og/eller (iii) den akutte hjerteforstyrrelse er et akut myokardieinfarkt (AMI) med ST-elevation på EKG, ustabilt angina, et akut ikke ST-eleveret myokardieinfarkt; hjerteiskæmi, akut hjerte læsion, akut hjerteskade som følge af akut lægemiddelforgiftning eller et akut kardiomyopati.
5. Fremgangsmåde ifølge et hvilket som helst af de foregående krav: (i) hvor den biologiske prøve er en blod-, veneblod-, arterieblod-, plasma-, serum-, spyt-, interstitielvæske, urin- eller hjertevævsprøve; og/eller niveauet af CNPsp-fragmentet måles ved anvendelse af et assay udvalgt fra massespektroskopi (indbefattende SELDI, ESI, MALDI eller FTIC), RIA, ELISA, fluoroimmunoassay, immunofluorometrisk assay og immunoradiometrisk assay.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, der endvidere omfatter måling af niveauet af én eller flere ikke-CNPsp-markører af AKS, og sammenligning af niveauerne med markømiveauer fra en kontrol, hvor en afvigelse i det målte niveau i forhold til kontrolniveauet, sammen med et målt niveau af CNPsp-fragmentet, der er større end kontrolniveauet af CNPsp-fragmentet, forudsiger eller diagnosticerer AKS, eller kan anvendes til at monitorere AKS, og hvor ikke-CNPsp-markøren er udvalgt fra gruppen bestående af troponin T, troponin I, creatinkinase-MB, myoglobin, ANP, ANP-SP, BNP, NT-BNP, BNP-SP, LDH, aspartataminotransferase, H-FABP, iskæmimodificeret albumin, endothelin, adrenomedullin, renin og angiotensin II.
7. Anvendelse af et antistof eller en antigenbindende del deraf, der specifikt eller selektivt binder til CNPsp-fragmentet ifølge SEQ ID NO: 6 i et assay til vurdering af en biologisk event eller forstyrrelse udført på en biologisk prøve fra en person; hvor den biologiske event eller forstyrrelse er AKS eller en nyreforstyrrelse.
8. Anvendelse ifølge krav 7, hvor antistoffet eller antigenbindende fragment deraf er et polyklonalt, monoklonalt, kimærisk eller humaniseret antistof eller det antigenbindende fragment deraf, og/eller hvor antistoffet eller det antigenbindende fragment deraf er mærket med en detekterbar markør.
9. Antistof eller antigenbindende del deraf, der selektivt eller specifikt binder til CNPsp-fragmentet ifølge SEQ ID NO: 6.
10. Antistof eller antigenbindende fragment deraf ifølge krav 9, der er et polyklonalt, monoklonalt, kimærisk eller humaniseret antistof eller antigenbindende fragment deraf, og/eller der er mærket med en detekterbar markør.
11. Isoleret peptid, der er CNPsp-fragmentet ifølge SEQ ID NO: 6.
12. Anvendelse af et peptid ifølge krav 11 i fremstillingen af et antistof.
13. Assay til et peptid ifølge krav 11 i en biologisk prøve fra en person, hvilket assay omfatter etablering af kontakt mellem prøven og et antistof eller antigenbindende del deraf ifølge lerav 9 eller 10, og detektering og måling af niveauet af peptidet i prøven anvendelse af en hvilken som helst kendt fremgangsmåde.
14. Assay ifølge krav 13 hvor: (i) den biologiske prøve er en prøve fra blod, veneblod, arterieblod, plasma, serum, spyt, interstitielvæske, urin, en hjerte vævsprøve eller nyrevævsprøve; (ii) niveauet af peptidet måles ved anvendelse af massespektroskopi, eller (iii) niveauet af peptidet måles ved anvendelse af et assay udvalgt fra RIA, ELISA, immunofluorometrisk assay og immunoradiometrisk assay.
15. Kit til forudsigelse, diagnosticering eller monitorering af en akut hjerteforstyrrelse, omfattende et antistof eller en antigenbindende del deraf ifølge krav 9; og eventuelt omfattende instruktioner til forudsigelse, diagnosticering eller monitorering af den akutte hjerteforstyrrelse hos en person inden seks til fire timer fra indtræden, eller klinisk præsentation, fra niveauet af et CNPsp-, eller CNPsp-fragment deraf, målt i en biologisk prøve, der er opnået inden seks eller fire timer fra indtræden, eller klinisk præsentation med AKS, og eventuelt hvor kittet er kalibreret til at måle niveauer af CNPsp, eller CNPsp-fragment deraf, inden for intervallet fra 0,1 til 1500 pmol/L, 0,1 til 350 pmol/L, 1 til 300 pmol/L, 10 til 250 eller 20 til 150 pmol/L.
DK11810311.8T 2010-07-19 2011-07-19 Signalbiomarkører DK2596010T3 (da)

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US36567710P 2010-07-19 2010-07-19
PCT/US2011/044586 WO2012012469A2 (en) 2010-07-19 2011-07-19 Signal biomarkers

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US (3) US9103840B2 (da)
EP (2) EP2596010B1 (da)
JP (2) JP6087816B2 (da)
CN (1) CN103140498B (da)
AU (2) AU2011282245B2 (da)
CA (1) CA2805794A1 (da)
DK (1) DK2596010T3 (da)
ES (1) ES2629850T3 (da)
NZ (2) NZ605640A (da)
WO (1) WO2012012469A2 (da)

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JP2011516038A (ja) 2008-03-12 2011-05-26 オタゴ イノベーション リミテッド バイオマーカー
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CA2805794A1 (en) 2012-01-26
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