HRP20171068T1 - Kombinacije i postupci za potkožno davanje imunoglobulina i hijaluronidaze - Google Patents
Kombinacije i postupci za potkožno davanje imunoglobulina i hijaluronidaze Download PDFInfo
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- HRP20171068T1 HRP20171068T1 HRP20171068TT HRP20171068T HRP20171068T1 HR P20171068 T1 HRP20171068 T1 HR P20171068T1 HR P20171068T T HRP20171068T T HR P20171068TT HR P20171068 T HRP20171068 T HR P20171068T HR P20171068 T1 HRP20171068 T1 HR P20171068T1
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- hyaluronidase
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- 108060003951 Immunoglobulin Proteins 0.000 title claims 31
- 102000018358 immunoglobulin Human genes 0.000 title claims 31
- 108010003272 Hyaluronate lyase Proteins 0.000 title claims 15
- 102000001974 Hyaluronidases Human genes 0.000 title claims 15
- 229960002773 hyaluronidase Drugs 0.000 title claims 15
- 238000007920 subcutaneous administration Methods 0.000 title claims 3
- 238000000034 method Methods 0.000 title 1
- 201000003874 Common Variable Immunodeficiency Diseases 0.000 claims 6
- 208000029462 Immunodeficiency disease Diseases 0.000 claims 4
- 201000010099 disease Diseases 0.000 claims 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 4
- 206010061598 Immunodeficiency Diseases 0.000 claims 3
- 201000002481 Myositis Diseases 0.000 claims 3
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 3
- 125000003275 alpha amino acid group Chemical group 0.000 claims 3
- 230000007813 immunodeficiency Effects 0.000 claims 3
- 239000007788 liquid Substances 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 208000008190 Agammaglobulinemia Diseases 0.000 claims 2
- 208000030939 Chronic inflammatory demyelinating polyneuropathy Diseases 0.000 claims 2
- 208000002250 Hematologic Neoplasms Diseases 0.000 claims 2
- 208000035186 Hemolytic Autoimmune Anemia Diseases 0.000 claims 2
- 206010020983 Hypogammaglobulinaemia Diseases 0.000 claims 2
- 208000034578 Multiple myelomas Diseases 0.000 claims 2
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 2
- 206010034277 Pemphigoid Diseases 0.000 claims 2
- 201000011152 Pemphigus Diseases 0.000 claims 2
- 206010042033 Stevens-Johnson syndrome Diseases 0.000 claims 2
- 208000031981 Thrombocytopenic Idiopathic Purpura Diseases 0.000 claims 2
- 206010044223 Toxic epidermal necrolysis Diseases 0.000 claims 2
- 201000000448 autoimmune hemolytic anemia Diseases 0.000 claims 2
- 201000003710 autoimmune thrombocytopenic purpura Diseases 0.000 claims 2
- 230000001580 bacterial effect Effects 0.000 claims 2
- 201000005795 chronic inflammatory demyelinating polyneuritis Diseases 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 238000001802 infusion Methods 0.000 claims 2
- 230000003612 virological effect Effects 0.000 claims 2
- XGWFJBFNAQHLEF-UHFFFAOYSA-N 9-anthroic acid Chemical compound C1=CC=C2C(C(=O)O)=C(C=CC=C3)C3=CC2=C1 XGWFJBFNAQHLEF-UHFFFAOYSA-N 0.000 claims 1
- 208000024827 Alzheimer disease Diseases 0.000 claims 1
- 241000228212 Aspergillus Species 0.000 claims 1
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 1
- 208000035143 Bacterial infection Diseases 0.000 claims 1
- 208000023706 Bruton agammaglobulinaemia Diseases 0.000 claims 1
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- 241000194017 Streptococcus Species 0.000 claims 1
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- 206010047124 Vasculitis necrotising Diseases 0.000 claims 1
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- 230000000735 allogeneic effect Effects 0.000 claims 1
- 210000003719 b-lymphocyte Anatomy 0.000 claims 1
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- 208000000594 bullous pemphigoid Diseases 0.000 claims 1
- 229940095731 candida albicans Drugs 0.000 claims 1
- 208000029192 congenital agammaglobulinemia Diseases 0.000 claims 1
- 230000002950 deficient Effects 0.000 claims 1
- 201000001981 dermatomyositis Diseases 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 230000001605 fetal effect Effects 0.000 claims 1
- 230000002538 fungal effect Effects 0.000 claims 1
- 230000005484 gravity Effects 0.000 claims 1
- 229940045808 haemophilus influenzae type b Drugs 0.000 claims 1
- 238000011134 hematopoietic stem cell transplantation Methods 0.000 claims 1
- 208000014752 hemophagocytic syndrome Diseases 0.000 claims 1
- 230000000642 iatrogenic effect Effects 0.000 claims 1
- 210000003000 inclusion body Anatomy 0.000 claims 1
- 208000037797 influenza A Diseases 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
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- 229920001184 polypeptide Polymers 0.000 claims 1
- 102000004196 processed proteins & peptides Human genes 0.000 claims 1
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- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 1
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- 238000002054 transplantation Methods 0.000 claims 1
- 230000008733 trauma Effects 0.000 claims 1
- 241000701161 unidentified adenovirus Species 0.000 claims 1
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
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- C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
- C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
- C12N9/2405—Glucanases
- C12N9/2408—Glucanases acting on alpha -1,4-glucosidic bonds
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- C12N9/2474—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
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Claims (14)
1. Kombinacija pripravaka imunoglobulina (IG) i topive hijaluronidaze za uporabu za liječenje bolesti ili stanja koje se liječi pomoću IG kod subjekta, naznačena time da:
su IG i topiva hijaluronidaza formulirani odvojeno za potkožno davanje;
IG i topiva hijaluronidaza su formulirani za primjenu u jednoj dozi jednom mjesečno;
topiva hijaluronidaza se daje odvojeno od IG prije davanja IG i na istom mjestu kao IG;
koncentracija IG je 5 do 15% m/v i količina IG u pripravku je 0.5 grama (g) do 70 g;
IG je formuliran u volumenu tekućine koji iznosi 50 mL do 700 mL;
topiva hijaluronidaza je formulirana za davanje kao omjer hijaluronidaze prema IG od 10 U/gram (g) do 500 U/g IG, pri čemu je količina hijaluronidaze u pripravku dovoljna za postizanje veće bioraspoloživosti IG kada se daje u kombinaciji s IG od barem 90% bioraspoloživosti iste jednostruke doze IG koja se daje pomoću intravenozne primjene za liječenje iste bolesti ili stanja koje se liječi pomoću IG;
topiva hijaluronidaza je formulirana u volumenu tekućine koja je 5 do 30 mL; i
bolest ili stanje koje se liječi pomoću IG je odabrano iz skupa koji čine imunodeficijencija; stečena hipogamaglobulinemija koja je sekundarna uz hematološke maligne bolesti; Kawasakijeva bolest; kronična upalna demijelinacijska polineuropatija (CIDP); Guillain-Barreov sindrom; idiopatska trombocitopenična purpura; upalne miopatije; Lambert-Eaton miastenični sindrom; multifokalna motorna neuropatija; miastenija gravis; Moersch-Woltmannov sindrom; sekundarna hipogamaglobulinemija, uključujući jatrogenu imunodeficijenciju; nedostatak specifičnih antitijela; akutni diseminirani encefalomijelitis; ANCA-pozitivni sistemski nekrotizirajući vaskulitis; autoimuna hemolitička anemija; bulozni pemfigoid; ožiljkasti pemfigoid; Evansov sindrom, uključujući autoimunu hemolitičku anemiju s imunom trombocitopenijom; fetalna/neonatalna aloimuna trombocitopenija (FNATP/NATP); hemofagocitni sindrom; visoko rizična alogena transplantacija krvotvornih matičnih stanica; paraproteinaemična neuropatija IgM; transplantacija bubrega; multipla skleroza; opsoklonus-mioklonus ataksija; pemfigus foliaceus; pemfigus vulgaris; purpura nakon transfuzije krvi; toksična epidermalna nekroliza/Stevens–Johnsonov sindrom (TEN/SJS); sindrom toksičnog šoka; Alzheimerova bolest; sistemski eritematozni lupus; multipli mijelom; sepsa; tumori B stanica; trauma; te bakterijske, virusne ili gljivične infekcije.
2. Kombinacija prema zahtjevu 1, naznačena time da je količina IG u pripravku 5 g, 10 g, 15 g, 20 g, 21 g, 22 g, 23 g, 24 g, 25 g, 26 g, 27 g, 28 g, 29 g, 30 g, 31 g, 32 g, 33 g, 34 g, 35 g, 36 g, 37 g, 38 g, 39 g ili 40 g.
3. Kombinacija prema zahtjevu 1, naznačena time da je IG u pripravku formuliran za supkutanu infuziju gravitacijom, pumpnom infuzijom ili ubrizgavanjem u količini koja je 20 do 30 grama.
4. Kombinacija prema zahtjevu 1, naznačena time da pripravak IG je 10% tekuća IG formulacija.
5. Kombinacija prema bilo kojem od zahtjeva 1-4, naznačena time da hijaluronidaza u pripravku je 5000 jedinica do 7500 jedinica ili 1,000 jedinica do 10,000 jedinica.
6. Kombinacija prema bilo kojem od zahtjeva 1-5, naznačena time da je hijaluronidaza u pripravku u količini koja je u omjeru (jedinica hijaluronidaze/grama IG) od 10 U/ gram (g), 20 U/g, 30 U/g, 35 U/g, 40 U/g, 50 U/g, 60 U/g, 70 U/g, 80 U/g, 90 U/g, 100 U/g, 150 U/g, ili 300 U/g.
7. Kombinacija prema zahtjevu 6, naznačena time da se hijaluronidaza u pripravku primjenjuje u omjeru od 50 U/ gram IG.
8. Kombinacija prema bilo kojem od zahtjeva 1-7, naznačena time da hijaluronidaza u pripravku je PH20, ili njezin skraćeni oblik.
9. Kombinacija ili pripravak prema zahtjevu 8, naznačen time da skraćeni ljudski PH20:
zadržava aktivnost hijaluronidaze i topiv je; te je
odabran od polipeptida koji imaju sekvencu aminokiselina navedenu u bilo kojem od SEQ ID NOS:4-9, ili sekvencu aminokiselina koja ima barem 91% identičnosti sekvence sa sekvencom aminokiselina navedenom u bilo kojem od SEQ ID NOS: 4-9.
10. Kombinacija prema bilo kojem od zahtjeva 1-9, naznačena time da je IG u pripravku pročišćen iz ljudske plazme.
11. Kombinacija prema bilo kojem od zahtjeva 1-10, naznačena time da IG u pripravku sadrži više od 95% IgG.
12. Kombinacija prema bilo kojem od zahtjeva 1-11, naznačena time da koncentracija IG je 6 do 15% m/v, ili 8 do 12% m/v pripravka IG.
13. Kombinacija prema zahtjevu 12, naznačena time da koncentracija IG je 10% m/v.
14. Kombinacija prema zahtjevu 1, naznačena time da je bolest ili stanje koje liječi IG odabrano od:
imunodeficijencije izabrane od obične varijabilne imunodeficijencije (CVID), urođene agamaglobulinemije, Wiskott-Aldrichovog sindroma, teške kombinirane imunodeficijencije (SCID), primarne hipogamaglobulinemije, primarnih bolesti imunodeficijencije s nedostatkom antitijela, spolno vezane agamaglobulinemije (XLA), hipogamaglobulinemije od djetinjstva, te paraneoplastične cerebelarne degeneracije bez antitijela;
stečene hipogamaglobulinemije pored hematoloških malignih bolesti odabranih od kronične limfocitne leukemije (CLL), multiplog mijeloma (MM) i ne-Hodgkinovog limfoma (NHL);
upalne miopatije odabrane od polimiozitisa, dermatomiozitisa i miozitisa s inkluzijskim tjelešcima; i
bakterijskog, virusnog ili gljivičnog stanja koje se bira od Haemophilus influenzae tip B, Pseudomonas aeruginosa tipovi A i B, Staphilococcus aureus, Streptococcus skupina B, Streptococcus pneumoniae tipovi 1, 3, 4, 6, 7, 8, 9, 12, 14, 18, 19, i 23, Adenovirus tipovi 2 i 5, citomegalovirusa, virusa Epstein Barr VCA, virusa hepatitisa A, virusa hepatitisa B, virusa Herpes simplex-1, virusa Herpes simplex-2, influence A, ospica, Parainfluence tipovi 1, 2 i 3, Polio, virusa Varicella zoster, Aspergillus i Candida albicans.
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| EP09721669.1A EP2271363B1 (en) | 2008-03-17 | 2009-03-16 | Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase |
| PCT/US2009/001670 WO2009117085A1 (en) | 2008-03-17 | 2009-03-16 | Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase |
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