HRP20190860T1 - POSTUPAK PROCJENJIVANJA RIZIKA OD PML-a - Google Patents

POSTUPAK PROCJENJIVANJA RIZIKA OD PML-a Download PDF

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Publication number
HRP20190860T1
HRP20190860T1 HRP20190860TT HRP20190860T HRP20190860T1 HR P20190860 T1 HRP20190860 T1 HR P20190860T1 HR P20190860T T HRP20190860T T HR P20190860TT HR P20190860 T HRP20190860 T HR P20190860T HR P20190860 T1 HRP20190860 T1 HR P20190860T1
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Croatia
Prior art keywords
patient
therapy
pml
vla
jcv
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HRP20190860TT
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English (en)
Inventor
Meena Subramanyam
Tatiana Plavina
Gary Lewis Bloomgren
Carmen Bozic
Sophia Lee
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Biogen Ma Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47260338&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20190860(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Biogen Ma Inc. filed Critical Biogen Ma Inc.
Publication of HRP20190860T1 publication Critical patent/HRP20190860T1/hr

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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
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983Viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2710/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA dsDNA viruses
    • C12N2710/00011Details
    • C12N2710/22011Polyomaviridae, e.g. polyoma, SV40, JC
    • 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
    • G01N2333/005Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/01DNA viruses
    • G01N2333/025Papovaviridae, e.g. papillomavirus, polyomavirus, SV40, BK virus, JC virus
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2469/00Immunoassays for the detection of microorganisms
    • G01N2469/20Detection of antibodies in sample from host which are directed against antigens from microorganisms
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/28Neurological disorders
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/28Neurological disorders
    • G01N2800/2814Dementia; Cognitive disorders
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/50Determining the risk of developing a disease
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Virology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Public Health (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Exhaust Gas After Treatment (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)

Claims (7)

1. Postupak procjene pacijentovog rizika od razvijanja progresivne multifokalne leukoencefalopatije (PML), postupak sadrži: određivanje titra antitijela JC Virusa (JCV), izraženo kao vrijednost indeksa u uzorku seruma ili plazme pacijenta pri čemu je za pacijenta ustanovljeno da ima visok rizik ako je određena vrijednost indeksa JCV antitijela >1,5; pri čemu se vrijednost indeksa određuje normaliziranjem OD vrijednosti uzorka prema odreznom kalibratoru, pri čemu je odrezni kalibrator prilagođen kako bi imao OD vrijednost od 1, pri čemu odrezni kalibrator sadrži smjesu seruma pozitivnog na JCV antitijela i seruma negativnog na JCV antitijela, pri čemu normaliziranje OD vrijednosti negativne kontrole koja sadrži serum negativan na JCV antitijela prema odreznom kalibratoru rezultira vrijednošću indeksa od 0,1, i pri čemu je titar JCV antitijela određen ELISA testom kako bi se detektirala JCV antitijela u uzorku.
2. Postupak prema zahtjevu 1, naznačen time što je titar JCV antitijela retestiran u 6-mjesečnim ili 12-mjesečnim intervalima, pri čemu povišenje u titru antitijela ili postotna inhibicija naznačuje povišenje pacijentovog rizika od razvijanja PML-a.
3. Postupak prema bilo kojem od zahtjeva 1-2, koji nadalje sadrži: (a) određivanje je li pacijent primao liječenje natalizumabom duže od 24 mjeseca; i/ili (b) određivanje je li pacijent primao specificiranu ne-anti-VLA-4 imunosupresijsku terapiju, pri čemu je specificirana ne-anti-VLA-4 imunosupresijska terapija odabrana od mitoksantrona, metotreksata, azatioprina, ciklofosfamida, mikofenolata, anti-CD20 terapije, anti-CD11a terapije i mikofenolat mofetila.
4. Postupak prema bilo kojem od zahtjeva 1-3, naznačen time što je pacijent klasificiran kao da ima viši rizik od PML-a ako je pacijent primao natalizumab duže od 24 mjeseca, te nije prethodno primao specificiranu ne-anti-VLA-4 imunosupresijsku terapiju, pri čemu je specificirana ne-anti-VLA-4 imunosupresijska terapija odabrana od mitoksantrona, metotreksata, azatioprina, ciklofosfamida, mikofenolata, anti-CD20 terapije, anti-CD11a terapije i mikofenolat mofetila.
5. Postupak prema bilo kojem od zahtjeva 1-4, koji nadalje sadrži praćenje pacijenata na razvoj PML-a, izborno pri čemu navedeno praćenje uključuje MRI skeniranje kako bi se identificirale lezije mozga.
6. Postupak procjenjivanja pacijentovog rizika od razvijanja PML-a prema zahtjevu 1, koji sadrži: (a) određivanje je li razina anti-JCV antitijela veća od vrijednosti indeksa od 1,5; (b) određivanje je li pacijent primao natalizumab duže od 24 mjeseca; i (c) određivanje je li pacijent primao ne-anti-VLA-4 imunosupresijsku terapiju, pri čemu je ne-anti-VLA-4 imunosupresijska terapija odabrana od mitoksantrona, metotreksata, azatioprina, ciklofosfamida, mikofenolata, anti-CD20 terapije, anti-CD11a terapije i mikofenolat mofetila; te ovisno o rezultatima, procjenjivanje pacijentovog rizika od razvijanja PML-a.
7. Postupak prema zahtjevu 1, naznačen time što pacijent prima terapiju natalizumabom.
HRP20190860TT 2011-05-31 2019-05-09 POSTUPAK PROCJENJIVANJA RIZIKA OD PML-a HRP20190860T1 (hr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US201161491810P 2011-05-31 2011-05-31
US201161508584P 2011-07-15 2011-07-15
US201161550257P 2011-10-21 2011-10-21
US201261636588P 2012-04-20 2012-04-20
PCT/US2012/040283 WO2012166971A2 (en) 2011-05-31 2012-05-31 Method of assessing risk of pml
EP12792375.3A EP2715352B1 (en) 2011-05-31 2012-05-31 Method of assessing risk of pml

Publications (1)

Publication Number Publication Date
HRP20190860T1 true HRP20190860T1 (hr) 2019-06-28

Family

ID=47260338

Family Applications (2)

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HRP20230186TT HRP20230186T1 (hr) 2011-05-31 2012-05-31 METODA PROCJENE RIZIKA OD PML-a
HRP20190860TT HRP20190860T1 (hr) 2011-05-31 2019-05-09 POSTUPAK PROCJENJIVANJA RIZIKA OD PML-a

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HRP20230186TT HRP20230186T1 (hr) 2011-05-31 2012-05-31 METODA PROCJENE RIZIKA OD PML-a

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US (2) US20190227064A1 (hr)
EP (3) EP4187248A1 (hr)
JP (5) JP6243838B2 (hr)
KR (3) KR102292563B1 (hr)
CN (1) CN103635803A (hr)
AU (1) AU2012262122B2 (hr)
CA (1) CA2836490A1 (hr)
CY (1) CY1121981T1 (hr)
DK (2) DK2715352T3 (hr)
ES (2) ES2939482T3 (hr)
FI (1) FI3575792T3 (hr)
HR (2) HRP20230186T1 (hr)
HU (2) HUE061244T2 (hr)
LT (2) LT2715352T (hr)
PL (2) PL3575792T3 (hr)
PT (2) PT3575792T (hr)
RS (2) RS58967B1 (hr)
SI (2) SI3575792T1 (hr)
WO (1) WO2012166971A2 (hr)

Families Citing this family (13)

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LT2676967T (lt) 2006-02-28 2019-09-10 Biogen Ma Inc. Uždegiminių ir autoimuninių ligų gydymo būdai su natalizumabu
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CA2776756A1 (en) 2009-10-11 2011-04-14 Biogen Idec Ma Inc. Anti-vla-4 related assays
IN2012DN06139A (hr) 2010-01-11 2015-09-18 Biogen Idec Inc
US11287423B2 (en) 2010-01-11 2022-03-29 Biogen Ma Inc. Assay for JC virus antibodies
WO2012166971A2 (en) 2011-05-31 2012-12-06 Biogen Idec Ma Inc. Method of assessing risk of pml
EP3004334A4 (en) 2013-05-28 2016-12-21 Biogen Ma Inc METHODS OF EVALUATION RISK OF DEVELOPMENT OF PML
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EP3757224A3 (en) 2014-02-27 2021-03-17 Biogen MA Inc. Method of assessing risk of pml
MA40985A (fr) 2014-11-17 2017-09-26 Biogen Ma Inc Méthodes de traitement de la sclérose en plaques
JP2021501152A (ja) 2017-10-26 2021-01-14 バイオジェン・エムエイ・インコーポレイテッドBiogen MA Inc. ナタリズマブの延長間隔投与
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EP3004334A4 (en) 2013-05-28 2016-12-21 Biogen Ma Inc METHODS OF EVALUATION RISK OF DEVELOPMENT OF PML

Also Published As

Publication number Publication date
PT3575792T (pt) 2023-02-28
KR102039751B1 (ko) 2019-11-01
JP2017191111A (ja) 2017-10-19
KR20140038440A (ko) 2014-03-28
WO2012166971A2 (en) 2012-12-06
JP6663396B2 (ja) 2020-03-11
US20190227064A1 (en) 2019-07-25
WO2012166971A8 (en) 2013-01-17
AU2012262122B2 (en) 2016-12-08
HUE043339T2 (hu) 2019-08-28
SI3575792T1 (sl) 2023-04-28
RS63989B1 (sr) 2023-03-31
JP2023169307A (ja) 2023-11-29
JP2022023126A (ja) 2022-02-07
EP2715352B1 (en) 2019-04-24
EP3575792B1 (en) 2022-11-30
JP7353338B2 (ja) 2023-09-29
KR20190122878A (ko) 2019-10-30
CA2836490A1 (en) 2012-12-06
JP2020101556A (ja) 2020-07-02
EP4187248A1 (en) 2023-05-31
JP7128221B2 (ja) 2022-08-30
AU2012262122A1 (en) 2013-11-14
FI3575792T3 (fi) 2023-03-17
HUE061244T2 (hu) 2023-06-28
CN103635803A (zh) 2014-03-12
KR102473834B1 (ko) 2022-12-02
ES2939482T3 (es) 2023-04-24
EP2715352A2 (en) 2014-04-09
SI2715352T1 (sl) 2019-06-28
DK2715352T3 (da) 2019-05-20
PL3575792T3 (pl) 2023-03-27
LT3575792T (lt) 2023-03-10
LT2715352T (lt) 2019-06-10
DK3575792T3 (da) 2023-02-27
ES2729945T3 (es) 2019-11-07
EP3575792A1 (en) 2019-12-04
PL2715352T3 (pl) 2019-09-30
JP6243838B2 (ja) 2017-12-06
HRP20230186T1 (hr) 2023-03-31
EP2715352A4 (en) 2015-10-21
JP2014518377A (ja) 2014-07-28
PT2715352T (pt) 2019-06-12
US20220011310A1 (en) 2022-01-13
KR102292563B1 (ko) 2021-08-24
CY1121981T1 (el) 2020-10-14
KR20210107138A (ko) 2021-08-31
WO2012166971A3 (en) 2013-03-07
RS58967B1 (sr) 2019-08-30

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