DK2089722T3 - Biomarkør til tidlig detektering af akutte hjerteforstyrrelser - Google Patents

Biomarkør til tidlig detektering af akutte hjerteforstyrrelser Download PDF

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DK2089722T3
DK2089722T3 DK07834867.9T DK07834867T DK2089722T3 DK 2089722 T3 DK2089722 T3 DK 2089722T3 DK 07834867 T DK07834867 T DK 07834867T DK 2089722 T3 DK2089722 T3 DK 2089722T3
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bnp
fragment
disorder
acute
gdp
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DK07834867.9T
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Christopher Joseph Pemberton
Arthur Mark Richards
Michael Gary Nicholls
Timothy Grant Yandle
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Otago Innovation Ltd
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74—Chemical 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/58—Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Cardionatrin; Cardiodilatin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/26—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against hormones ; against hormone releasing or inhibiting factors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • 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
    • G01N33/6887—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids from muscle, cartilage or connective tissue
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • 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
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575—Hormones
    • G01N2333/58—Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/32—Cardiovascular disorders
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/32—Cardiovascular disorders
    • G01N2800/324—Coronary artery diseases, e.g. angina pectoris, myocardial infarction
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • General Physics & Mathematics (AREA)
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  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Cardiology (AREA)
  • Peptides Or Proteins (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Claims (17)

1. BNP-SP-fragment-assay-fremgangsmåde til diagnosticering af en akut hjerteforstyrrelse hos et individ, hvor BNP-SP-fragmentet er BNP-SP (17-26) (SEQ ID NO: 19), og hvor assayet omfatter detektering af BNP-SP-fragmentet i en prøve opnået fra et individ inden for to timer efter forekomst af forstyrrelsen eller inden for to timer efter klinisk præsentation af forstyrrelsen.
2. BNP-SP-fragment-assay-fremgangsmåde til at monitorere en akut hjerteforstyrrelse hos et individ, monitorere et respons på behandling af en akut koronar forstyrrelse hos et individ, forudsige, diagnosticere eller monitorere en hjertetransplantatafvisningsepisode hos et individ eller skelne mellem en lungeforstyrrelse og en akut hjerteforstyrrelse hos et individ, hvor BNP-SP-fragmentet er BNP-SP (17-26) (SEQ ID NO: 19), og hvor assayet omfatter detektering af BNP-SP-fragmentet i en prøve opnået fra et individ inden for to timer efter forekomst af forstyrrelsen eller inden for to timer efter klinisk præsentation af forstyrrelsen.
3. Assay-fremgangsmåde ifølge krav 1 eller 2, der er et RIA, et ELISA, et fluorimmunoassay, et immunofluorometrisk assay eller et immunoradiometrisk assay, eller udføres ved anvendelse af massespektroskopi (indbefattende SELDI, ESI, MALDI og FTICR).
4. Anvendelse af et BNP-SP-fragment-specifikt bindingsmiddel til fremstilling af et BNP-SP-fragment-assay-kit til at evaluere en akut hjerteforstyrrelse hos et individ, hvor BNP-SP-fragmentet er BNP-SP (17-26) (SEQ ID NO: 19), hvor assayet omfatter detektering af BNP-SP-fragmentet i en prøve opnået fra et individ inden for to timer efter forekomst af forstyrrelsen eller inden for to timer efter klinisk præsentation af forstyrrelsen.
5. Anvendelse ifølge krav 4, hvor bindingsmidlet er et antistof eller antistoffragment, der indbefatter monoklonale, polyklonale, kimæriske og humaniserede antistoffer og antistoffragmenter.
6. BNP-SP-fragment-bindingsmiddel-assay-fremgangsmåde, der omfatter trinnene med: a) evaluering af niveauet af et BNP-SP-fragment hos et individ i de to første timer efter forekomst eller klinisk præsentation af en mistænkt akut hjerteforstyrrelse, en hjertetransplantatafvisningsepisode eller en lunge-/akut hjerteforstyrrelse, b) sammenligning af niveauet af BNP-SP-fragmentet med en BNP-SP-fragmentkontrolværdi og c) bestemmelse af, om der er en afvigelse fra kontrollen, hvor BNP-SP-fragmentet er BNP-SP (17-26) (SEQ ID NO: 19).
7. Assay-fremgangsmåde ifølge krav 6, hvor det bestemmes, hvorvidt der er en ændring fra afvigelse fra kontrollen på 5 % eller mere, på 10 % eller mere, på 20 % eller mere eller på 50 % eller mere eller alternativt, hvorvidt niveauet af BNP-SP-fragment er fire til ti gange højere end kontrollen.
8. Assay-fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3 og 6 til 7, hvor den akutte hjerteforstyrrelse er en akut hjerteiskæmi.
9. Assay-fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3 og 6 til 7, hvor den akutte hjerteforstyrrelse er et akut myokardieinfarkt, et akut myokardieinfarkt med ST-forhøjelse ved præsentation af EKG, ustabil angina, et akut ikke-ST-forhøjet myokardieinfarkt, en akut hjertelæsion, en akut hjerteskade som følge af akut lægemiddeltoksicitet, en akut kardiomyopati eller en hjertetransplantatafvisning.
10. Assay-fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3 og 6 til 9, hvor BNP-SP-fragment-assayet eller bindingsmidlet anvendes til at evaluere BNP-SP-fragmentniveauer hos et individ inden for 30 minutter, inden for én time eller inden for to timer efter forekomst af en akut hjerteforstyrrelse eller klinisk præsentation af en akut hjerteforstyrrelse, en hjertetransplantatafvisningsepisode eller en lunge-/akut koronar forstyrrelse.
11. Assay-fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3 og 6 til 10, hvor BNP-SP-fragmentet evalueres i blod, plasma, serum, spyt eller en hjertevævsprøve fra individet.
12. Assay-fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3 og 6 til 11, hvor individet er et menneske.
13. Kit til forudsigelse, diagnosticering eller monitorering af en akut hjerteforstyrrelse, en hjertetransplantatafvisningsepisode, eller en lunge-/akut hjerteforstyrrelse, der omfatter BNP-SP-fragmentbindingsmidlet, der selektivt binder til BNP-SP-fragmentpolypeptidet ifølge SEQ ID NO: 19, hvor kittet er beregnet til anvendelse med en biologisk prøve opnået fra et individ inden for to timer efter forekomst eller klinisk præsentation af akut hjerteforstyrrelse, hjertetransplantatafvisning eller lungeforstyrrelse/akut hjerteforstyrrelse, hvilket kit eventuelt indbefatter instruktioner til forudsigelse, diagnosticering eller monitorering af en akut hjerteforstyrrelse, en hjertetransplantatafvisningsepisode eller en lunge-/akut hjerteforstyrrelse.
14. Antistof eller antistoffragment, der selektivt binder til BNP-SP- fragmentpolypeptidet ifølge SEQ ID NO: 19, hvilket antistof eller antistoffragment er mærket med en detekterbar markør eller ikke-mærket.
15. Isoleret BNP-SP-fragmentpolypeptid, der er polypeptidet ifølge SEQ ID NO: 19.
16. Anvendelse af BNP-SP-fragmentpolypeptidet ifølge SEQ ID NO: 19 i fremstillingen af et anti-BNP-SP-fragmentantistof.
17. Assay-fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3 og 6 til 7, der endvidere omfatter måling af en ikke-BNP-SP-fragmentmarkør udvalgt fra gruppen bestående af troponin T, troponin I, kreatinkinase-MB, myoglobin, BNP, NT-BNP og H-FABP.
DK07834867.9T 2006-09-07 2007-09-07 Biomarkør til tidlig detektering af akutte hjerteforstyrrelser DK2089722T3 (da)

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US84264906P 2006-09-07 2006-09-07
PCT/NZ2007/000265 WO2008030122A1 (en) 2006-09-07 2007-09-07 Biomarkers

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EP (1) EP2089722B1 (da)
JP (1) JP5994121B2 (da)
CN (1) CN101611318B (da)
AU (1) AU2007293777B2 (da)
CA (1) CA2662629C (da)
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ES (1) ES2655564T3 (da)
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US8298772B2 (en) 2012-10-30
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US20090239246A1 (en) 2009-09-24
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