HRP20221504T1 - Postupci procjene rizika od razvoja progresivne multifokalne leukoencefalopatije uzrokovane john cunningham virusom pomoću genetskog testiranja - Google Patents
Postupci procjene rizika od razvoja progresivne multifokalne leukoencefalopatije uzrokovane john cunningham virusom pomoću genetskog testiranja Download PDFInfo
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- HRP20221504T1 HRP20221504T1 HRP20221504TT HRP20221504T HRP20221504T1 HR P20221504 T1 HRP20221504 T1 HR P20221504T1 HR P20221504T T HRP20221504T T HR P20221504TT HR P20221504 T HRP20221504 T HR P20221504T HR P20221504 T1 HRP20221504 T1 HR P20221504T1
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- immunosuppressive drug
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Classifications
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- 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
- 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
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- 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
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- 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
- C12Q2600/156—Polymorphic or mutational markers
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Claims (11)
1. Imunosupresivni lijek za upotrebu u liječenju stanja kod subjekta kojem je potrebna terapija imunosupresivnim lijekom,
naznačen time što subjekt ima smanjen rizik od progresivne multifokalne leukoencefalopatije (PML) zbog infekcije mozga John Cunningham virusom (JCV),
pri čemu je subjektov smanjeni rizik posljedica nepostojanja genomske varijacije
izabrane iz skupine koju čine: chr1:57409459, C>A, chr22:35806756, G>A i chr21:45708278, G>A,
pri čemu je položaj kromosoma genomske varijacije definiran s obzirom na UCSC hg19.
2. Imunosupresivni lijek za upotrebu prema patentnom zahtjevu 1, naznačen time što je stanje rak, transplantacija organa ili autoimuna bolest,
izborno pri čemu:
(i) autoimuna bolest je odabrana iz skupine koju čine Addisonova bolest, encefalitis anti-NMDA receptora, sindrom antisintetaze, aplastična anemija, autoimuna anemija, autoimuna hemolitička anemija, autoimuni pankreatitis, Behcetova bolest, bulozni kožni poremećaji, celijakija - spru (enteropatija osjetljiva na gluten), sindrom kroničnog umora, kronična upalna demijelinizirajuća polineuropatija, kronična limfocitna leukemija, Crohnova bolest, dermatomiozitis, Devicova bolest, eritroblastopenija, Evansov sindrom, fokalna segmentalna glomeruloskleroza, granulomatoza s poliangiitisom, Gravesova bolest, Gravesova oftalmopatija, sindrom Guillain-Barré, Hashimotov tiroiditis, idiopatska trombocitopenična purpura (ITP), IgA nefropatija, IgA-posredovane autoimune bolesti, bolest povezana s IgG4, upalna bolest crijeva, juvenilni idiopatski artritis, multipla skleroza, miastenija gravis, mijelom, ne-Hodgkinov limfom, opsoklonus mioklonus sindrom (OMS), pemfigoid, pemfigus, pemfigus vulgaris, perniciozna anemija, polimiozitis, psorijaza, čista aplazija crvenih krvnih zrnaca, reaktivni artritis, reumatoidni artritis, sarkoidoza, sklerodermija, Sjögrenov sindrom, sistemski eritematozni lupus, trombocitopenična purpura, trombotična trombocitopenična purpura, dijabetes tipa I, ulcerozni kolitis, vaskulitis, vitiligo, i njihove kombinacije;
(ii) autoimuna bolest je multipla skleroza ili Crohnova bolest; ili
(iii) autoimuna bolest je relapsirajući oblik multiple skleroze.
3. Imunosupresivni lijek za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, naznačen time što
(i) imunosupresivni lijek sadrži abatacept, akalabrutinib, adalimumab, agatolimod natrij, aldesleukin, alefacept, alemtuzumab, alisertib, alvespimicin hidroklorid, alvocidib, aminokamptotecin, anakinra, andekaliksimab, anifrolumab, antitimocitni Ig, apatinib, apelizib, asparaginazu, atacicept, atezolizumab, avelumab, azacitidin, azatioprin, bafetinib, baminercept, baricitinib, baziliksimab, bekatekarin, begelomab, belatacept, belimumab, bemcentinib, bendamustin, betalutin s lilotomabom, bevacizumab, bimekizumab, binimetinib, bleomicin, blinatumomab, bortezomib, brentuksimab vedotin, briostatin 1, bucilamin, buparlisib, busulfan, kanakinumab, kapecitabin, karboplatin, karfilzomib, karmustin, cediranib maleat, cemiplimab, cerdulatinib, certolizumab, cetuksimab, chidamid, klorambucil, cilengitid, cirmtuzumab, cisplatin, kladribin, clazakizumab, cliokinol, kortikosteroide, ciklofosfamid, ciklosporin, citarabin, citotoksičnu kemoterapiju, daklizumab, daratumumab, dasatinib, defaktinib, defibrotid, denosumab, deksametazon, diacerein, dimetil fumarat, dinaciklib, doksorubicin, doksorubicin, durvalumab, duvelisib, duvortuksizumab, eculizumab, efalizumab, eftilagimod alfa, enkorafenib, entinostat, entospletinib, enzastaurin, epakadostat, epirubicin, epratuzumab, eritoran tetranatrij, etanercept, etopozid, everolimus, evobrutinib, filgotinib, fingolimod, firategrast, fludarabin, fluorouracil, fontolizumab, forodesin hidroklorid, fostamatinib, galunisertib, ganetespib, ganitumab, gemcitabin, gemtuzumab ozogamicin, gerilimzumab, glasdegib, glasia, glatiramer acetat, glembatumumab vedotin, glezatinib, golimumab, guadecitabin, hidrokortizon, hidroksiklorokin sulfat, hidroksiureu, ibritumomab tiuksetan, ibrutinib, ibudilast, idarubicin, idelalisib, ifosfamid, igvratimod, imatinib, imekson, infliksimab, inotuzumab ozogamicin, interferon alfa-2, interferon beta-1a, interferon beta-Ib, interferon gama-1, ipilimumab, irofulven, isatuksimab, ispinezib, itacitinib, iksazomib, lapatinib, lakinimod, laromustin, ld-aminopterin, leflunomid, lenalidomid, lenvatinib, levamizol, lirilumab, lonafarnib, lumiliksimab, masitinib, mavrilimumab, melfalan, merkaptopurin, metotreksat, metokssalen, metilprednizon, milatuzumab, mitoksantron, mizoribin, mocetinostat, monalizumab, mosunetuzumab, motesanib difosfat, moksetumomab pasudotoks, muromonab-CD3, mikofenolat mofetil, mikofenolnu kiselinu, namilumab, natalizumab, navitoklaks, neihulizumab, neurovaks, niraparib, nivolumab, obatoklaks mezilat, obinutuzumab, oblimersen natrij, okrelizumab, ofatumumab, olokizumab, opicinumab, oprelvekin, osimertinib, oteliksizumab, oksaliplatin, ozanimod, paklitaksel, pakritinib, palifermin, panobinostat, pazopanib, pefikitinib, peginterferon beta-la, pegsunercept (peg stnf-ri), pembrolizumab, pemetreksed, penklomedin, pentostatin, perifosin, pevonedistat, peksidartinib, pikoplatin, pidilizumab, pivaneks, piksantron, pleneva, plovamer acetat, polatuzumab vedotin, pomalidomid, ponatinib, ponezimod, prednizon/prednizolon, piroksamid, rekombinantni il-12, relatlimab, rhigf-1, rhigm22, rigosertib, rilonacept, rituksimab, ruksolitinib, sarilumab, sekukinumab, selumetinib, sintilimab, siplizumab, siponimod, sirolimus, sirukumab, sitravatinib, sonidegib, sorafenib, sotrastaurin acetat, sunitinib, tabalumab, takrolimus, talabostat mezilat, talakotuzumab, tanespimicin, tegafur/gimeracil/oteracil, temozolomid, temsirolimus, tenalizib, terameprokol, teriflunomid, talidomid, tiarabin, tiotepa, tipifarnib, tirabrutinib, tislelizumab, tivozanib, tocilizumab, tofacitinib, tregalizumab, tremelimumab, treosulfan, ublituksimab, umbralisib, upadacitinib, urelumab, ustekinumab, varlilumab, vatelizumab, vedolizumab, veliparib, veltuzumab, venetoklaks, vinblastin, vinkristin, vinorelbie ditartrat, visilizumab, vismodegib, vistusertib, vorinostat, vosaroksin, ziv-aflibercept, ili 6,8-bis(benziltio) oktansku kiselinu;
(ii) imunosupresivni lijek sadrži natalizumab, interferon beta-la, interferon beta-lb, glatiramer acetat, peginterferon beta-la, teriflunomid, fingolimod, dimetil fumarat, alemtuzumab, mitoksantron, rituksimab, daklizumab, okrelizumab ili siponimod; ili
(iii) imunosupresivni lijek sadrži adalimumab, alemtuzumab, alemtuzumab, azatioprin, belimumab, bevacizumab, bortezomib, ekulizumab, leflunomid, brentuksimab vedotin, cetuksimab, ciklofosfamid, dimetil fumarat, efalizumab, fingolimod, fludarabin, fumarnu kiselinu, imatinib, infliksimab, metotreksat, mikofenolat mofetil, natalizumab, daklizumab, rituksimab, vedolizumab, ruksolitinib ili okrelizumab.
4. Imunosupresivni lijek za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, naznačen time što imunosupresivni lijek sadrži natalizumab, izborno pri čemu:
(i) natalizumab se primjenjuje putem intravenske infuzije;
(ii) primjenjuje se oko 100 mg do oko 500 mg natalizumaba;
(iii) primjenjuje se oko 100 mg do oko 500 mg natalizumaba u četiri tjedna;
(iv) primjenjuje se oko 100 mg do oko 500 mg natalizumaba putem intravenske infuzije u četiri tjedna;
(v) primjenjuje se oko 100 mg do oko 500 mg natalizumaba putem intravenske infuzije u šest tjedana;
(vi) primjenjuje se oko 100 mg do oko 500 mg natalizumaba putem intravenske infuzije u osam tjedana; ili
(vii) natalizumab primjenjuje se potkožno.
5. Imunosupresivni lijek za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, naznačen time što su genomske sekvence subjekta određene genetskim testom koji obuhvaća otkrivanje genomske varijacije u uzorku polinukleinske kiseline dobivenom od subjekta, izborno pri čemu:
(i) genetski test uključuje analizu cijelog genoma ili cijelog egzoma subjekta;
(ii) genetski test uključuje analizu informacija o nukleinskim kiselinama koje su već dobivene za cijeli genom ili cijeli egzom subjekta;
(iii) genetski test uključuje analizu informacija o nukleinskim kiselinama koje su već dobivene za cijeli genom ili cijeli egzom subjekta, pri čemu se informacije o nukleinskim kiselinama dobivaju iz in silico analize;
(iv) subjekt je ljudski subjekt; ili
(v) uzorak polinukleinske kiseline sadrži polinukleinsku kiselinu iz krvi, sline, urina, seruma, suza, kože, tkiva ili kose subjekta.
6. Imunosupresivni lijek za upotrebu prema patentnom zahtjevu 5, naznačen time što genetski test uključuje analizu mikronizova, PCR, sekvencioniranje, hibridizaciju nukleinske kiseline ili bilo koju njihovu kombinaciju, izborno pri čemu:
(i) analiza mikronizova odabrana je iz skupine koja se sastoji od analize niza komparativne genomske hibridizacije (CGH) i SNP analize niza, ili
(ii) sekvenciranje je odabrano iz skupine koja se sastoji od masivnog paralelnog signaturnog sekvenciranja (MPSS), polonijskog sekvenciranja, 454 pirosekvenciranja, sekvenciranja tehnologijom Illumina, sekvenciranja tehnologijom Illumina (Solexa) korištenjem 10X Genomics knjižnice pripreme, SOLiD sekvenciranja, ionskog poluvodičkog sekvenciranja, sekvenciranja DNK nanoloptica, heliskopskog sekvenciranja pojedinačne molekule, sekvenciranja pojedinačne molekule u stvarnom vremenu (SMRT), RNAP sekvenciranja, Nanopore DNK sekvenciranja, sekvenciranja hibridizacijom i mikrofluidnog Sangerovog sekvenciranja.
7. Imunosupresivni lijek za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, naznačen time što je genomska varijacija heterozigotni SNV ili homozigotni SNV.
8. Imunosupresivni lijek za upotrebu prema bilo kojem prethodnom patentnom zahtjevu, naznačen time što:
(a) imunosupresivni lijek za upotrebu nadalje sadrži sredstvo koje smanjuje JCV virusno opterećenje kod subjekta; ili
(b) imunosupresivni lijek je za primjenu prije ili zajedno sa sredstvom koje smanjuje količinu virusa kod subjekta,
izborno pri čemu:
(i) imunosupresivni lijek se primjenjuje nakon što je virusno opterećenje smanjeno; ili
(ii) sredstvo koje smanjuje virusno opterećenje je sredstvo koje cilja na JCV.
9. Postupak smanjenja rizika da subjekt razvije progresivnu multifokalnu leukoencefalopatiju (PML) naznačen time što obuhvaća
(a) testiranje subjekta na prisutnost genomske varijacije odabrane iz skupine koju čine: chr1:57409459, C>A, chr22:35806756, G>A i chr21:45708278, G>A, pri čemu je položaj kromosoma genoma varijacija definirana s obzirom na UCSC hg19;
(b) određivanje da subjekt ima genomsku varijaciju, i
(c) savjetovanje protiv primjene imunosupresivnog lijeka subjektu za kojeg je utvrđeno da ima genomsku varijaciju, pri čemu imunosupresivni lijek sadrži natalizumab,
izborno pri čemu:
(i) savjetovanje uključuje savjetovanje da je primjena imunosupresivnog lijeka kontraindicirana;
(ii) savjetovanje uključuje savjetovanje da primjena imunosupresivnog lijeka povećava rizik da subjekt razvije progresivnu multifokalnu leukoencefalopatiju (PML);
(iii) savjetovanje uključuje savjetovanje da je primjena imunosupresivnog lijeka čimbenik koji povećava rizik da subjekt razvije progresivnu multifokalnu leukoencefalopatiju (PML); ili
(iv) pri čemu imunosupresivni lijek sadrži natalizumab.
10. Postupak identificiranja subjekta koji ima rizik od razvoja progresivne multifokalne leukoencefalopatije (PML) naznačen time što obuhvaća:
(a) analiziranje uzorka polinukleinske kiseline subjekta na genomsku varijaciju odabranu iz skupine koju čine: chr1:57409459, C>A, chr22:35806756, G>A i chr21:45708278, G>A, pri čemu je položaj kromosoma genomska varijacija definirana s obzirom na UCSC hg19;
(b) utvrđivanje prisutnosti genetske varijacije u uzorku polinukleinske kiseline; i
(c) identificiranje ispitanika kao subjekta s visokim rizikom od razvoja PML;
pri čemu je subjekt imunosuprimiran,
izborno pri čemu subjekt ima HIV, primio je transplantaciju organa ili pati od stanja odabranog od raka, hematološke maligne bolesti, autoimune bolesti ili idiopatske CD4+ limfocitopenije (ICL).
11. Imunosupresivni lijek za upotrebu prema bilo kojem od patentnih zahtjeva 1 do 8, ili postupak prema zahtjevu 9 ili 10, naznačen time što nadalje uključuje analizu prisutnosti JCV u biološkom uzorku subjekta, pri čemu analiza prisutnosti JCV uključuje JCV-test na protutijela ili test CSF IgM oligoklonalne trake,
izborno pri čemu:
analiza na prisutnost JCV-a uključuje testiranje subjekta testom JCV-protutijela, pri čemu test JCV-protutijela otkriva ili ne otkriva prisutnost JCV, ili
test JCV-protutijela uključuje dovođenje u kontakt reagensa za otkrivanje JCV s biološkim uzorkom subjekta, izborno pri čemu je reagens za otkrivanje JCV odabran iz skupine koja se sastoji od anti-JCV protutijela, početnice specifične za JCV i njihovih kombinacija.
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| US201862716072P | 2018-08-08 | 2018-08-08 | |
| US201862716183P | 2018-08-08 | 2018-08-08 | |
| PCT/US2019/045721 WO2020033700A1 (en) | 2018-08-08 | 2019-08-08 | Mathods for assessing the risk of developing progressive multifocal leukoencephalopathy caused by john cunningham virus by genetic testing |
| EP19765344.7A EP3625368B8 (en) | 2018-08-08 | 2019-08-08 | Methods for assessing the risk of developing progressive multifocal leukoencephalopathy caused by john cunningham virus by genetic testing |
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| AU (1) | AU2019316556B9 (hr) |
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| DK (1) | DK3625368T3 (hr) |
| ES (1) | ES2935891T3 (hr) |
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| HR (1) | HRP20221504T1 (hr) |
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| TW202214874A (zh) * | 2020-06-08 | 2022-04-16 | 印度商裘拉德製藥私人有限公司 | 用於人類個體中基因分型sting變體之快速方法 |
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| US10961585B2 (en) | 2021-03-30 |
| DK3625368T3 (da) | 2022-12-19 |
| AU2019316556B2 (en) | 2023-12-14 |
| EP3625368B1 (en) | 2022-11-09 |
| EP3625368A1 (en) | 2020-03-25 |
| AU2019316556B9 (en) | 2024-01-04 |
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