HRP20140789T1 - Postupci primjene protutijela protiv il-5 - Google Patents

Postupci primjene protutijela protiv il-5 Download PDF

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HRP20140789T1
HRP20140789T1 HRP20140789AT HRP20140789T HRP20140789T1 HR P20140789 T1 HRP20140789 T1 HR P20140789T1 HR P20140789A T HRP20140789A T HR P20140789AT HR P20140789 T HRP20140789 T HR P20140789T HR P20140789 T1 HRP20140789 T1 HR P20140789T1
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antibody
intended
antibody against
accordance
administered
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HRP20140789AT
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Bela Rajiv Patel
Deborah Smith
Debra J. Tompson
Parnian Zia-Amirhosseini
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Glaxosmithkline Llc
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/04Antipruritics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • AHUMAN NECESSITIES
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    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P7/10Antioedematous agents; Diuretics
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    • C07K2317/00Immunoglobulins specific features
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

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  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
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Claims (15)

1. Protutijelo protiv IL-5, namijenjeno upotrebi u smanjivanju broja eozinofila kod čovjeka koji boluje od hipereozinofilnog sindroma, naznačeno time što navedeno protutijelo protiv IL-5 primijeniti na navedenom čovjeku u pripravku koji sadrži navedeno najmanje jedno protutijelo protiv IL-5, gdje navedeno protutijelo protiv IL-5 ima teški lanac koji sadrži SEQ ID NO: 19 i laki lanac koji sadrži SEQ ID NO: 21, te osigurava srednju najveću koncentracija u plazmi navedenog protutijela protiv IL-5 od najmanje 1,03 ± 0,21 µg/ml do 278 629 µg/ml, a vrijednost površine pod krivuljom(0-∞) za navedeno protutijelo protiv IL-5 je najmanje 15,5 ± 2,7 µg×dan/ml do 4361 6168 µg×dan/ml.
2. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 1, naznačeno time što je navedena srednja najveća koncentracija u plazmi u rasponu od 12,1 ± 2,4 µg/ml do 278 629 µg/ml i/ili što je navedeni AUC(0-∞) u rasponu od 207 634 µg×dan/ml do 4361 ± 168 µg×dan/ml.
3. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 1 ili patentni zahtjev 2, naznačeno time što navedeni pripravak koji sadrži najmanje jedno protutijelo protiv IL-5 treba primijeniti supkutano.
4. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 3, naznačeno time što navedeni pripravak koji sadrži protutijelo treba primijeniti u dozi od 250 mg.
5. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 4, naznačeno time što navedenu supkutanu dozu treba primijeniti jednom do tri puta.
6. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 5, naznačeno time što je srednja koncentracija u plazmi navedenog protutijela 34,1 ± 12,1 µg/ml do 38,2 ± 9,1 µg/ml i/ili što je AUC(0-∞) za navedeno protutijelo 1110 ± 372 µg×dan/ml do 1196 ± 254 µg×dan/ml.
7. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 1, naznačeno time što navedeni pripravak koji sadrži protutijelo treba primijeniti intramuskularno.
8. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 7, naznačeno time što se navedeni pripravak koji sadrži protutijelo primjenjuje u dozi od 250 mg.
9. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 8, naznačeno time što je navedena srednja koncentracija u plazmi navedenog protutijela 46,9 ± 10,6 µg/ml, a AUC(0-∞) za navedeno protutijelo je 1395 ± 348 µg×dan/ml.
10. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 1, naznačeno time što navedeni pripravak koji sadrži protutijelo treba primijeniti intravenski.
11. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 10, naznačeno time što navedeni pripravak koji sadrži protutijelo treba primijeniti u dozi od 250 mg ili u dozi od 750 mg.
12. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 10 ili 11, naznačeno time što se protutijelo primjenjuje infuzijom, u trajanju od otprilike 30 minuta.
13. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s patentnim zahtjevom 10, naznačeno time što je navedena srednja koncentracija u plazmi navedenog protutijela 109 ± 17,0 µg/ml, a AUC(0-∞) za navedeno protutijelo je 1557 ± 250 µg×dan/ml.
14. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačeno time što navedeno protutijelo ima serumski poluvijek od 16,2 ± 2,1 dan do 21,7 ± 2,8 dana.
15. Protutijelo protiv IL-5, namijenjeno upotrebi u skladu s bilo kojim od patentnih zahtjeva 1 do 14, naznačeno time što se navedeni pripravak koji sadrži protutijelo primjenjuje zajedno sa steroidom.
HRP20140789AT 2007-04-30 2014-08-20 Postupci primjene protutijela protiv il-5 HRP20140789T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US91483307P 2007-04-30 2007-04-30
US99071507P 2007-11-28 2007-11-28
PCT/US2008/062015 WO2008134721A1 (en) 2007-04-30 2008-04-30 Methods for administering anti-il-5 antibodies

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HRP20140789T1 true HRP20140789T1 (hr) 2014-10-10

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US (5) US20100086554A1 (hr)
EP (4) EP2152290B1 (hr)
JP (6) JP2010526088A (hr)
CY (1) CY1115456T1 (hr)
DK (1) DK2152290T3 (hr)
ES (1) ES2492943T3 (hr)
HR (1) HRP20140789T1 (hr)
LT (1) LTC2152290I2 (hr)
PL (1) PL2152290T3 (hr)
PT (1) PT2152290E (hr)
SI (1) SI2152290T1 (hr)
WO (2) WO2008134724A2 (hr)

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EP2606906A1 (en) 2013-06-26
EP2152290A1 (en) 2010-02-17
WO2008134724A2 (en) 2008-11-06
EP2152290A4 (en) 2010-06-02
JP2017036296A (ja) 2017-02-16
PL2152290T3 (pl) 2014-11-28
CY1115456T1 (el) 2017-01-04
JP2015028042A (ja) 2015-02-12
JP2020019781A (ja) 2020-02-06
LTC2152290I2 (lt) 2018-12-27
PT2152290E (pt) 2014-09-03
SI2152290T1 (sl) 2014-09-30
JP2018158934A (ja) 2018-10-11
EP2152310A2 (en) 2010-02-17
US20200040073A1 (en) 2020-02-06
DK2152290T3 (da) 2014-08-18
LTPA2016005I1 (lt) 2018-11-12
US20160096886A1 (en) 2016-04-07
US20100086554A1 (en) 2010-04-08
EP2152310A4 (en) 2010-05-26
EP2777710A1 (en) 2014-09-17
EP2152290B1 (en) 2014-06-04
JP2010526088A (ja) 2010-07-29
US20100086547A1 (en) 2010-04-08
ES2492943T3 (es) 2014-09-10
US20180022799A1 (en) 2018-01-25
WO2008134721A1 (en) 2008-11-06
JP2010526087A (ja) 2010-07-29
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