HRP20140251T1 - Monoklonska protutijela specifiäśna za a beta 1-42, s terapijskim svojstvima - Google Patents
Monoklonska protutijela specifiäśna za a beta 1-42, s terapijskim svojstvima Download PDFInfo
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- HRP20140251T1 HRP20140251T1 HRP20140251TT HRP20140251T HRP20140251T1 HR P20140251 T1 HRP20140251 T1 HR P20140251T1 HR P20140251T T HRP20140251T T HR P20140251TT HR P20140251 T HRP20140251 T HR P20140251T HR P20140251 T1 HRP20140251 T1 HR P20140251T1
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- 230000001225 therapeutic effect Effects 0.000 title 1
- 239000000427 antigen Substances 0.000 claims 12
- 102000036639 antigens Human genes 0.000 claims 12
- 108091007433 antigens Proteins 0.000 claims 12
- 201000010099 disease Diseases 0.000 claims 11
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 11
- 206010002022 amyloidosis Diseases 0.000 claims 9
- 238000000034 method Methods 0.000 claims 8
- 208000024827 Alzheimer disease Diseases 0.000 claims 6
- 102000009091 Amyloidogenic Proteins Human genes 0.000 claims 6
- 108010048112 Amyloidogenic Proteins Proteins 0.000 claims 6
- 208000010877 cognitive disease Diseases 0.000 claims 6
- 208000027061 mild cognitive impairment Diseases 0.000 claims 6
- 210000004408 hybridoma Anatomy 0.000 claims 5
- 241000124008 Mammalia Species 0.000 claims 4
- 230000015572 biosynthetic process Effects 0.000 claims 4
- 210000004027 cell Anatomy 0.000 claims 4
- 230000001149 cognitive effect Effects 0.000 claims 4
- 208000018282 ACys amyloidosis Diseases 0.000 claims 3
- 206010065040 AIDS dementia complex Diseases 0.000 claims 3
- 206010007509 Cardiac amyloidosis Diseases 0.000 claims 3
- 208000005145 Cerebral amyloid angiopathy Diseases 0.000 claims 3
- 208000010859 Creutzfeldt-Jakob disease Diseases 0.000 claims 3
- 206010012289 Dementia Diseases 0.000 claims 3
- 206010067889 Dementia with Lewy bodies Diseases 0.000 claims 3
- 201000010374 Down Syndrome Diseases 0.000 claims 3
- 208000001976 Endocrine Gland Neoplasms Diseases 0.000 claims 3
- 208000007487 Familial Cerebral Amyloid Angiopathy Diseases 0.000 claims 3
- 208000032849 Hereditary cerebral hemorrhage with amyloidosis Diseases 0.000 claims 3
- 201000002832 Lewy body dementia Diseases 0.000 claims 3
- 241001465754 Metazoa Species 0.000 claims 3
- 201000002481 Myositis Diseases 0.000 claims 3
- 208000012902 Nervous system disease Diseases 0.000 claims 3
- 208000025966 Neurological disease Diseases 0.000 claims 3
- 208000018737 Parkinson disease Diseases 0.000 claims 3
- 206010044688 Trisomy 21 Diseases 0.000 claims 3
- 210000004556 brain Anatomy 0.000 claims 3
- 201000011523 endocrine gland cancer Diseases 0.000 claims 3
- 239000012634 fragment Substances 0.000 claims 3
- 201000010901 lateral sclerosis Diseases 0.000 claims 3
- 208000002780 macular degeneration Diseases 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 208000005264 motor neuron disease Diseases 0.000 claims 3
- 201000006417 multiple sclerosis Diseases 0.000 claims 3
- 201000002212 progressive supranuclear palsy Diseases 0.000 claims 3
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 3
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 2
- 208000007660 Residual Neoplasm Diseases 0.000 claims 2
- 208000037765 diseases and disorders Diseases 0.000 claims 2
- 230000000694 effects Effects 0.000 claims 2
- 230000000116 mitigating effect Effects 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 102000013455 Amyloid beta-Peptides Human genes 0.000 claims 1
- 108010090849 Amyloid beta-Peptides Proteins 0.000 claims 1
- 229940088623 biologically active substance Drugs 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000002708 enhancing effect Effects 0.000 claims 1
- 230000001747 exhibiting effect Effects 0.000 claims 1
- 238000012544 monitoring process Methods 0.000 claims 1
- 239000002773 nucleotide Substances 0.000 claims 1
- 125000003729 nucleotide group Chemical group 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000002157 polynucleotide Substances 0.000 claims 1
- 102000040430 polynucleotide Human genes 0.000 claims 1
- 108091033319 polynucleotide Proteins 0.000 claims 1
- 230000009257 reactivity Effects 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
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
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- A—HUMAN NECESSITIES
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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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
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- 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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- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
- G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
- G01N2333/4701—Details
- G01N2333/4709—Amyloid plaque core protein
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Claims (21)
1. Protutijelo, ili njegov funkcionalan dio, koje može prepoznati i vezati se na specifični epitop u amiloidu beta, naznačeno time što navedeno protutijelo, ili njegov funkcionalan dio, sadrži fragment monoklonskog protutijela koji se veže na epitop, kojeg se može dobiti iz hibridomne stanične linije FP 12H3-C2, deponirane 01. prosinca 2005. kao DSM ACC2750.
2. Monoklonsko protutijelo, ili njegov funkcionalan dio, u skladu s patentnim zahtjevom 1, naznačeno time što ga proizvodi hibridomna stanična linija FP 12H3-C2, deponirana 01. prosinca 2005. kao DSM ACC2750.
3. Protutijelo u skladu s bilo kojim od prethodnih patentnih zahtjeva, ili njegovi funkcionalni dijelovi, naznačeno time što je monoklonsko protutijelo, ili kimerno protutijelo.
4. Humanizirano protutijelo, ili njegov funkcionalan dio, naznačeno time što navedeno protutijelo, ili njegov funkcionalan dio, sadrži područja koja određuju komplementarnost (CDR) monoklonskog protutijela, koje se može dobiti iz hibridomne stanične linije FP 12H3-C2, deponirane 01. prosinca 2005. kao DSM ACC2750.
5. Polinukleotid, naznačen time što sadrži nukleotidni slijed koji kodira protutijelo, ili njegov funkcionalan dio, u skladu s bilo kojim od patentnih zahtjeva 1-4.
6. Stanična linija, naznačena time što proizvodi protutijelo, ili njegov funkcionalan dio, u skladu s bilo kojim od patentnih zahtjeva 1-4.
7. Stanična linija u skladu s patentnim zahtjevom 6, naznačena time što je hibridomna stanična linija FP 12H3-C2, deponirana 01. prosinca 2005. kao DSM ACC2750.
8. Postupak proizvodnje protutijela, ili njegovog funkcionalnog dijela, u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačena time što se sastoji u uzgoju stanične linije u kulturi u skladu s patentnim zahtjevom 6 ili 7.
9. Protutijelo, ili njegov funkcionalan dio, u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačeno time što se proizvodi postupkom u skladu s patentnim zahtjevom 8.
10. Pripravak, naznačen time što sadrži protutijelo, ili njegov funkcionalan dio, u skladu s bilo kojim od patentnih zahtjeva 1 do 4, i izborno dodatno sadrži farmaceutski prihvatljivu podlogu.
11. Pripravak u skladu s patentnim zahtjevom 10, naznačen time što je namijenjen upotrebi u liječenju bolesti i poremećaja koje uzrokuju ili su povezani s amiloidnim ili amiloidima sličnim proteinima, uključujući amiloidozu.
12. Smjesa, naznačena time što sadrži protutijelo, ili njegov funkcionalan dio, u skladu s bilo kojim od patentnih zahtjeva 1 do 4 i, izborno, dodatnu biološki aktivnu tvar koju se upotrebljava u liječenju bolesti i poremećaja koje uzrokuju ili su povezani s amiloidnim ili amiloidima sličnim proteinima i/ili farmaceutski prihvatljivu podlogu i/ili razrjeđivač i/ili pomoćnu tvar.
13. Upotreba protutijela i/ili njegovog funkcionalnog dijela u skladu s bilo kojim od patentnih zahtjeva 1 do 4 ili pripravka u skladu s patentnim zahtjevom 10 ili 11, ili smjese u skladu s patentnim zahtjevom 12, u pripravi medikamenta za liječenje ili ublažavanje učinaka amiloidoze, uključujući, no bez ograničavanja na:
(a) neurološke poremećaje, poput Alzheimerove bolesti (AD);
(b) bolesti ili stanja, naznačenih time što je za njih karakterističan gubitak sposobnosti kognitivnog pamćenja, poput, primjerice, blagog kognitivnog poremećaja (MCI), demencije Lewyjevih tijela, Downovog sindroma, nasljednog krvarenja u velikom mozgu uz amiloidozu (nizozemskog tipa), te guamskog Parkinson-demencijskog kompleksa; i
(c) progresivnu supranuklearnu paralizu, multiplu sklerozu, Creutzfeld-Jacobovu bolest, Parkinsonovu bolest, demenciju povezanu s HIV-om, ALS (amiotropna lateralna skleroza), inkluzivni miozitis (IBM), dijabetes s početkom u odrasloj dobi, staračku amiloidozu srca, endokrine tumore, te degeneraciju makule.
14. Postupak priprave protutijela, ili njegovog funkcionalnog dijela, u skladu s bilo kojim od patentnih zahtjeva 1 do 4, ili pripravka u skladu s patentnim zahtjevom 10 ili 11, ili smjese u skladu s patentnim zahtjevom 12, namijenjen upotrebi u liječenju ili ublažavanju učinaka amiloidoze, uključujući, no bez ograničavanja na:
(a) neurološke poremećaje, poput Alzheimerove bolesti (AD);
(b) bolesti ili stanja, naznačenih time što je za njih karakterističan gubitak sposobnosti kognitivnog pamćenja, poput, primjerice, blagog kognitivnog poremećaja (MCI), demencije Lewyjevih tijela, Downovog sindroma, nasljednog krvarenja u velikom mozgu uz amiloidozu (nizozemskog tipa), te guamskog Parkinson-demencijskog kompleksa; i
(c) progresivnu supranuklearnu paralizu, multiplu sklerozu, Creutzfeld-Jacobovu bolest, Parkinsonovu bolest, demenciju povezanu s HIV-om, ALS (amiotropna lateralna skleroza), inkluzivni miozitis (IBM), dijabetes s početkom u odrasloj dobi, staračku amiloidozu srca, endokrine tumore, te degeneraciju makule.
15. Pripravak u skladu s patentnim zahtjevom 10 ili 11, namijenjen upotrebi u:
(a) smanjivanju opterećenja plakovima ili u smanjivanju količine plakova u mozgu životinje, osobito sisavca, no prije svega čovjeka koji boluje od bolesti ili stanja povezanog s amiloidima; ili
(b) smanjivanju količine plakova u mozgu životinje, osobito sisavca, no prije svega čovjeka koji boluje od bolesti ili stanja povezanog s amiloidima; ili
(c) smanjivanju ukupne količine topljivog Aβ u mozgu životinje, osobito sisavca, no prije svega čovjeka koji boluje od bolesti ili stanja povezanog s amiloidima; ili
(d) sprječavanju, liječenju ili ublažavanju učinaka amiloidoze, uključujući, no bez ograničavanja na:
(i) neurološke poremećaje, poput Alzheimerove bolesti (AD);
(ii) bolesti ili stanja, naznačenih time što je za njih karakterističan gubitak sposobnosti kognitivnog pamćenja, poput, primjerice, blagog kognitivnog poremećaja (MCI), demencije Lewyjevih tijela, Downovog sindroma, nasljednog krvarenja u velikom mozgu uz amiloidozu (nizozemskog tipa), te guamskog Parkinson-demencijskog kompleksa; i
(iii) progresivnu supranuklearnu paralizu, multiplu sklerozu, Creutzfeld-Jacobovu bolest, Parkinsonovu bolest, demenciju povezanu s HIV-om, ALS (amiotropna lateralna skleroza), inkluzivni miozitis (IBM), dijabetes s početkom u odrasloj dobi, staračku amiloidozu srca, endokrine tumore, te degeneraciju makule; ili
(e) zadržavanju ili povećavanju sposobnost kognitivnog pamćenja kod sisavca koji pokazuje bolest ili stanje povezano s amiloidima.
16. Stanična linija u skladu s patentnim zahtjevom 6, naznačena time što je hibridomna stanična linija.
17. Postupak dijagnosticiranja bolesti ili stanja povezanog s amiloidima kod pacijenta koji se sastoji u detektiranju imunospecifičnog vezanja protutijela, ili njegovog aktivnog fragmenta, na epitop u amiloidnom proteinu u uzorku, naznačen time što uključuje korake:
a) dovođenja uzorka za kojeg se sumnja da sadrži amiloidni antigen u kontakt s protutijelom, ili njegovim funkcionalnim dijelom, u skladu s bilo kojim od patentnih zahtjeva 1-4, gdje se navedeno protutijelo, ili njegov funkcionalan dio, veže na epitop u amiloidnom proteinu;
b) omogućavanja da se protutijelo, ili njegov funkcionalan dio, veže na amiloidni antigen kako bi nastao imunološki kompleks;
c) detektiranja nastajanja imunološkog kompleksa; i
d) koreliranja prisutnosti ili odsutnosti imunološkog kompleksa s prisutnošću ili odsutnošću amiloidnog antigena u uzorku.
18. Postupak dijagnosticiranja sklonosti prema bolesti ili stanju povezanom s amiloidima kod pacijenta koji se sastoji u detektiranju imunospecifičnog vezanja protutijela, ili njegovog aktivnog fragmenta, na epitop u amiloidnom proteinu u uzorku, naznačen time što uključuje korake:
a) dovođenja uzorka za kojeg se sumnja da sadrži amiloidni antigen u kontakt s protutijelom, ili njegovim funkcionalnim dijelom, u skladu s bilo kojim od patentnih zahtjeva 1-4, gdje se navedeno protutijelo, ili njegov funkcionalan dio, veže na epitop u amiloidnom proteinu;
b) omogućavanja da se protutijelo, ili njegov funkcionalan dio, veže na amiloidni antigen kako bi nastao imunološki kompleks;
c) detektiranja nastajanja imunološkog kompleksa;
d) koreliranja prisutnosti ili odsutnosti imunološkog kompleksa s prisutnošću ili odsutnošću amiloidnog antigena u uzorku; i
e) uspoređivanja količine navednog imunološkog kompleksa to a normalna kontrolna vrijednost,
gdje povećanje količine navednog agregata u usporedbi s normalnom kontrolnom vrijednošću ukazuje da je navedni pacijent u opasnosti da mu se razvije bolest ili stanje povezano s amiloidima.
19. Postupak praćenja minimalne preostale bolesti kod pacijenta nakon liječenja protutijelom, ili njegovim funkcionalnim dijelom, ili pripravkom u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se navedeni postupak sastoji u:
a) dovođenju uzorka za kojeg se sumnja da sadrži amiloidni antigen u kontakt s protutijelom, ili njegovim funkcionalnim dijelom, u skladu s bilo kojim od patentnih zahtjeva 1-4, gdje se navedeno protutijelo, ili njegov funkcionalan dio, veže na epitop u amiloidnom proteinu;
b) omogućavanju da se protutijelo, ili njegov funkcionalan dio, veže na amiloidni antigen kako bi nastao imunološki kompleks;
c) detektiranju nastajanja imunološkog kompleksa;
d) koreliranju prisutnosti ili odsutnosti imunološkog kompleksa s prisutnošću ili odsutnošću amiloidnog antigena u uzorku; i
e) uspoređivanju količine navedenog imunološkog kompleksa to a normalna kontrolna vrijednost,
gdje povećanje količine navedenog agregata u usporedbi s normalnom kontrolnom vrijednošću ukazuje da navedeni pacijent i dalje boluje od minimalne preostale bolesti.
20. Postupak predviđanja reaktivnosti kod pacijenta kojeg se liječi protutijelom, ili njegovim funkcionalnim dijelom, ili pripravkom u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što se sastoji u:
a) dovođenju uzorka za kojeg se sumnja da sadrži amiloidni antigen u kontakt s protutijelom, ili njegovim funkcionalnim dijelom, u skladu s bilo kojim od patentnih zahtjeva 1-4, gdje se navedeno protutijelo, ili njegov funkcionalan dio, veže na epitop u amiloidnom proteinu;
b) omogućavanju da se protutijelo, ili njegov funkcionalan dio, veže na amiloidni antigen kako bi nastao imunološki kompleks;
c) detektiranju nastajanja imunološkog kompleksa;
d) koreliranju prisutnosti ili odsutnosti imunološkog kompleksa s prisutnošću ili odsutnošću amiloidnog antigena u uzorku; i
e) uspoređivanju količine navedenog imunološkog kompleksa prije i nakon početka liječenja,
gdje smanjenje količine navedenog agregata ukazuje da navedeni pacijent ima visoki potencijal da reagira na liječenje.
21. Komplet za ispitivanje, namijenjen detektiranju i dijagnosticiranju bolesti i stanja povezanih s amiloidima, naznačen time što sadrži protutijelo, ili njegov funkcionalan dio, u skladu s bilo kojim od patentnih zahtjeva 1-4.
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| HRP20140333TT HRP20140333T1 (hr) | 2005-12-12 | 2014-04-07 | A beta 1-42 specifiäśna monoklonalna antitijela sa terapeutskim svojstvima |
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