HRP20140887T1 - Dijagnoza karcinoma i lijeäśenje, koje se temelji na odc1 genotipu - Google Patents

Dijagnoza karcinoma i lijeäśenje, koje se temelji na odc1 genotipu Download PDF

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HRP20140887T1
HRP20140887T1 HRP20140887AT HRP20140887T HRP20140887T1 HR P20140887 T1 HRP20140887 T1 HR P20140887T1 HR P20140887A T HRP20140887A T HR P20140887AT HR P20140887 T HRP20140887 T HR P20140887T HR P20140887 T1 HRP20140887 T1 HR P20140887T1
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patient
preparation
aspirin
use according
dfmo
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HRP20140887AT
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Eugene Gerner
Jason Zell
Christine Mclaren
Frank Meyskens
Hoda Anton-Culver
Patricia A. Thompson
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Arizona Board Of Regents On Behalf Of University Of Arizona
The Regents Of The University Of California, A California Corporation
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
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    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • C12Q1/6886—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material for cancer
    • G01N33/57535—
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/106—Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
    • C—CHEMISTRY; METALLURGY
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    • C12Q—MEASURING 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/112—Disease subtyping, staging or classification
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q2600/00—Oligonucleotides characterized by their use
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING 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
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers
    • 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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  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Biomedical Technology (AREA)
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Claims (14)

1. Pripravak koji sadrži α-difluorometilornitin (DFMO) i nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin, za uporabu kod prevencije ili za kurativno liječenje kolorektalnog karcinoma ili njegovih faktora rizika kod pacijenta; naznačen time da genotip pacijenta na položaju +316 na barem jednom ODC1 alelu promotorskog gena je G; te naznačen time da liječenje faktora rizika kolorektalnog karcinoma kod pacijenta sprečava stvaranje novih aberantnih kripti crijevnog žljezdanog epitela, novih adenomatoznih polipa ili novih adenoma sa displazijom u pacijentu; proizvoljno pri čemu pacijent je čovjek.
2. Pripravak koji sadrži α-difluorometilornitin (DFMO), za uporabu kod prevencije ili za kurativno liječenje kolorektalnog karcinoma, ili njegovog faktora rizika kako je definirano u zahtjevu 1, kod pacijenta kao što je definirano u zahtjevu 1 naznačen time da se pacijentu također daje pripravak koji sadrži nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin, te se pacijentu daje pripravak koji sadrži nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin prije, istovremeno, ili poslije davanja pripravka koji sadrži DFMO.
3. Pripravak koji sadrži nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin, za uporabu kod prevencije ili za kurativno liječenje kolorektalnog karcinoma, ili njegovog faktora rizika kako je definirano u zahtjevu 1, kod pacijenta kao što je definirano u zahtjevu 1 naznačen time da se pacijentu također daje pripravak koji sadrži α-difluorometilornitin (DFMO), te se pacijentu daje pripravak koji sadrži DFMO prije, istovremeno, ili poslije davanja pripravka koji sadrži nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin.
4. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-3, naznačen time da se genotip pacijenta određuje primanjem izvješća koje sadrži navedeni genotip ili uzimanjem anamneze pacijenta koja otkriva rezultate; ili određivanjem nukleotidne baze na položaju +316 za jedan alel za ODC1 promotorski gen pacijenta; ili određivanjem nukleotidnih baza na položaju +316 za oba alela za ODC1 promotorski gen pacijenta.
5. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-3, naznačen time da genotip pacijenta na položaju +316 za oba alela za ODC1 promotorski gen je GG ili GA.
6. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-5, naznačen time da, prije određivanja genotipa pacijenta, pacijent je već bio liječen sa pripravkom koji sadrži DMFO i/ili nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin, ali u nižoj dozi od DMFO i/ili ne-steroidnog protuupalnog lijeka (NSAID) koji sadrži ne-aspirin.
7. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-6, naznačen time da je nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin odabran iz skupine koju čine selektivni inhibitor COX-2, sulindac i celekoksib.
8. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-7, naznačen time da nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin je sulindac, te pri čemu (i) DFMO se daje oralno, proizvoljno pri čemu je učinkovita količina DFMO 500 mg/dan; (ii) DFMO se daje intravenozno, proizvoljno pri čemu je učinkovita količina DFMO od 0.05 do 5.0 g/m2/dan; ili (iii) te se DFMO daje najmanje drugi puta.
9. Pripravak za uporabu prema bilo kojem patentnom zahtjevu 1-7, naznačen time da nesteroidni protuupalni lijek (NSAID) koji sadrži ne-aspirin je sulindac, te pri čemu je učinkovita količina sulindaca od 10 do 1500 mg/dan, kao što je od 10 do 400 mg/dan, ili kao 150 mg/dan; ili pri čemu se sulindac daje najmanje drugi puta.
10. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-7, naznačen time da navedeni pacijent ima solidni tumor, te je solidni tumor reseciran.
11. Pripravak za uporabu prema bilo kojem od patentnih zahtjeva 1-10, naznačen time da je kolorektalni karcinom u fazi I, ili fazi II, ili fazi III, ili fazi IV.
12. Pripravak za uporabu prema bilo kojem patentnom zahtjevu 1-11, naznačen time da tretman sprečava stvaranje novih napredujućih neoplazmi debelog crijeva (npr. nove napredujuće neoplazme desne strane debelog crijeva ili nove napredujuće neoplazme lijeve strane debelog crijeva) kod pacijenta, ili tretman sprečava ototoksičnost ili rizik za ototoksičnost kod pacijenta.
13. Pripravak za uporabu prema bilo kojem patentnom zahtjevu 1-12, naznačen time da pacijent je identificiran da ima - (i) jedan ili više adenomatoznih polipa u debelom crijevu, rektumu ili slijepom crijevu; (ii) jedan ili više napredujućih neoplazmi debelog crijeva; ili (iv) dijagnozu obiteljske adenomatozne polipoze.
14. Pripravak za uporabu prema bilo kojem patentnom zahtjevu 1-13, naznačen time da pacijent ima povijest resekcije jednog ili više adenoma debelog crijeva.
HRP20140887AT 2009-05-14 2010-05-14 Dijagnoza karcinoma i lijeäśenje, koje se temelji na odc1 genotipu HRP20140887T1 (hr)

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US21621609P 2009-05-14 2009-05-14
US21767909P 2009-06-03 2009-06-03
US21768209P 2009-06-03 2009-06-03
PCT/US2010/034974 WO2010132817A1 (en) 2009-05-14 2010-05-14 Carcinoma diagnosis and treatments, based on odc1 genotype

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US (4) US8329636B2 (hr)
EP (1) EP2430452B1 (hr)
JP (2) JP6083860B2 (hr)
CN (1) CN102483415B (hr)
AU (1) AU2010248803B2 (hr)
CA (1) CA2761946A1 (hr)
DK (1) DK2430452T3 (hr)
ES (1) ES2507145T3 (hr)
HR (1) HRP20140887T1 (hr)
IL (1) IL216369B (hr)
PL (1) PL2430452T3 (hr)
PT (1) PT2430452E (hr)
SI (1) SI2430452T1 (hr)
SM (1) SMT201400177B (hr)
WO (1) WO2010132817A1 (hr)

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