DK2329259T3 - Markører og fremgangsmåder til bedømmelse og behandling af ulcerativ colitis og beslægtede sygdomme under anvendelse af et 20-genpanel - Google Patents

Markører og fremgangsmåder til bedømmelse og behandling af ulcerativ colitis og beslægtede sygdomme under anvendelse af et 20-genpanel Download PDF

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DK2329259T3
DK2329259T3 DK09810643.8T DK09810643T DK2329259T3 DK 2329259 T3 DK2329259 T3 DK 2329259T3 DK 09810643 T DK09810643 T DK 09810643T DK 2329259 T3 DK2329259 T3 DK 2329259T3
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sample
nucleic acid
patient
tnfα antibody
ulcerative colitis
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Xilin Li
Frederic Baribaud
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Janssen Biotech Inc
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    • 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
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/106Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/156Polymorphic or mutational markers
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00Oligonucleotides characterized by their use
    • C12Q2600/158Expression markers
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/06Gastro-intestinal diseases
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/06Gastro-intestinal diseases
    • G01N2800/065Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
    • 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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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
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  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
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  • Hematology (AREA)
  • Biomedical Technology (AREA)
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  • Cell Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (15)

1. Fremgangsmåde til forudsige egnetheden af behandling med målterapi til en gastrointestinal-beslægtet sygdom i et individ, hvor individet er en patient tilvejebringe prøven før administration af terapien, og hvor terapien er et anti-TNFa-antistof, omfattende: a) tilvejebringe en prøve af nukleinsyrer fra et prøvemateriale opnået fra individet; b) bringe prøven i kontakt med et panel af nukleinsyresegmenter bestående af SEQ ID NO: 1-20 for at påvise niveauerne af panelsegmenterne; c) bedømme prøven mod en referencestandard fra en responder til terapien for at bestemme de relative ekspressionsniveauer fra alle medlemmer fra gruppen bestående af nukleotidsekvenser svarende til SEQ ID NO: 1-20 sammenlignet med referencestandarden; og d) korrelere de relative ekspressionsniveauer fra prøven og referencestandarden med egnetheden af behandling med mål-terapien for den gastrointestinalt-beslægtede forstyrrelse.
2. Fremgangsmåden ifølge krav 1, hvor anti-TNFa-antistoffet er infliximab.
3. Fremgangsmåden ifølge krav 2, hvor den gastrointestinalt-beslægtede forstyrrelse er ulcerativ colitis.
4. Fremgangsmåden ifølge krav 3, hvor referencestandarden er fra en colonbiopsi fra en responder til målterapien.
5. Fremgangsmåden ifølge krav 1, hvor panelet er et array af nukleinsyresegmenter.
6. Fremgangsmåden ifølge krav 1, hvor prøven omfatter en colonbiopsiprøve eller perifere blodceller.
7. Fremgangsmåde ifølge krav 1, der er en array-baseret testfremgangsmåde til at forudsige egnetheden af behandling med målterapi til en gastrointestinal-beslægtet forstyrrelse hos en patient, omfattende: a) fremstille en blanding af nukleinsyrer fra et prøvemateriale opnået fra patienten; b) mærke disse nukleinsyreprøver med en påviselig markør for at danne en prøve; c) bringe prøven i kontakt med et array omfattende en flerhed af nukleinsyresegmenter, hvor hvert nukleinsyresegment er er immobiliseret til en diskret og kendt adresse på en substratoverflade af arrayet, hvor et gastrointestinal-beslægtet genpanel bestående af nukleotidsekvenser svarende til SEQ ID NO: 1-20 identificeres som træk af arrayet ved adresse, og hvor arrayet yderligere omfatter mindst én kalibreringsnukleinsyre ved en kendt adresse på substratet; d) bestemme bindingsgraden af nukleinsyreprøverne til nukleinsyresegmenterne; og e) sammenligne bindingsgraden med referencestandarden for at muliggøre bedømmelsen af egnetheden for behandling.
8. Fremgangsmåden ifølge krav 7, hvor sammenligningstrinnet omfatter at bedømme prøven mod en referencestandard for at bestemme styrkeændringen i mængderne af nukleotidsekvenser svarende til SEQ ID NOS: 1-20.
9. Fremgangsmåden ifølge krav 8, hvor: i) den gastrointestinalt-beslægtede forstyrrelse er ulcerativ colitis og det gastrointestinal-beslægtede genpanel er et ulcerativ colitis-beslægtet genpanel; ii) mål-terapien er et anti-TNFa-antistof; iii) prøven er fra en colonbiopsi fra en patient valgt fra gruppen bestående af patienter der er mistænkt for at have ulcerativ colitis og patienter diagnosticeret med ulcerativ colitis der ikke undergår behandling; iv) prøven er fra en kilde valgt fra gruppen bestående af en patient der tilvejebringer prøven før administration af terapi, en patient havende en lignende sygdom eller tilstand behandlet med placebo, og en prøve fra en biobank; v) prøven omfatter en colon-biopsiprøve eller perifere blodceller; eller vi) sammenligne graden af bindingstrinnet yderligere omfatter en stringent test af sammenlignelighed af trækintensitetsændringer af arrayet af det ulcerative colitis-beslægtede genpanel.
10. Reagens til testning af egnetheden af et anti-TNFa-antistof til en gastrointestinal-beslægtet forstyrrelse i en celle eller individ før administration af anti-TNFa-antistoffet, omfattende oligonukleotider omfattende mindst 15 nukleotider omfattende eller komplementær med en nukleotidsekvens for hver af nukleotidsekvenserne svarende til SEQ ID NOS: 1-20,
11. Reagenset ifølge krav 10, hvor den gastrointestinalt-beslægtede forstyrrelse er ulcerativ colitis og eventuelt hvor anti-TNFa-antistoffet er infliximab.
12. Fremgangsmåde til testning af egnetheden af et anti-TNFa-antistof til en gastrointestinal-beslægtet forstyrrelse i en patientprøve fra en patient før administration af anti-TNFa-antistoffet, omfattende at bringe patientprøven i kontakt med reagenset ifølge krav 10 og sammenligne niveauerne på mindst en del af hver af generne fra nukleotidsekvenser svarende til SEQ ID NO: 1-20 med en referencestandard, hvor referencestandarden er fra en responder til anti-TNFa-antistoffet.
13. Fremgangsmåden ifølge krav 12: i) hvor testningen foretages ved RT-PCR eller ii) hvor anti-TNFa-antistoffet er infliximab.
14. Fremgangsmåde til testning af effektiviteten af et anti-TNFa-antistof for ulcerativ colitis, omfattende: a) at bringe en prøve fra en patient der bliver behandlet for ulcerativ colitis i kontakt med reagenset ifølge krav 10; b) måle niveauerne fra de 20 medlemmer; og c) korrelere niveauerne fra de 20 medlemmer med effektiviteten af anti-TNFa-antistoffet ved at sammenligne niveauerne med niveauer i en referencestandard, hvor referencestandarden er fra en responder til anti-TNFa-antistoffet.
15. Fremgangsmåden ifølge krav 14, hvor anti-TNFa-antistoffet er infliximab.
DK09810643.8T 2008-08-29 2009-08-28 Markører og fremgangsmåder til bedømmelse og behandling af ulcerativ colitis og beslægtede sygdomme under anvendelse af et 20-genpanel DK2329259T3 (da)

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US9296608P 2008-08-29 2008-08-29
PCT/US2009/055323 WO2010025340A2 (en) 2008-08-29 2009-08-28 Markers and methods for assessing and treating ulcerative colitis and related disorders using a 20 gene panel

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US (1) US20100069256A1 (da)
EP (1) EP2329259B1 (da)
JP (1) JP5586607B2 (da)
CN (1) CN102165315B (da)
AU (1) AU2009285644B2 (da)
BR (1) BRPI0917379A2 (da)
CA (1) CA2734519C (da)
DK (1) DK2329259T3 (da)
ES (1) ES2581774T3 (da)
IL (1) IL211154A0 (da)
RU (1) RU2011111748A (da)
WO (1) WO2010025340A2 (da)

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WO2010025340A2 (en) 2010-03-04
AU2009285644B2 (en) 2015-08-20
CN102165315B (zh) 2014-06-18
JP2012501452A (ja) 2012-01-19
AU2009285644A1 (en) 2010-03-04
EP2329259A2 (en) 2011-06-08
EP2329259A4 (en) 2012-05-16
IL211154A0 (en) 2011-04-28
CA2734519A1 (en) 2010-03-04
WO2010025340A3 (en) 2010-04-22
JP5586607B2 (ja) 2014-09-10
EP2329259B1 (en) 2016-04-20
CN102165315A (zh) 2011-08-24
BRPI0917379A2 (pt) 2015-11-17
US20100069256A1 (en) 2010-03-18
CA2734519C (en) 2018-11-13
ES2581774T3 (es) 2016-09-07
RU2011111748A (ru) 2012-10-10

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