HRP20140333T1 - A beta 1-42 specifiäśna monoklonalna antitijela sa terapeutskim svojstvima - Google Patents
A beta 1-42 specifiäśna monoklonalna antitijela sa terapeutskim svojstvima Download PDFInfo
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Claims (21)
1. Antitijelo ili njegov funkcionalni dio, koji može prepoznavati i vezivati specifični epitop amiloida beta pri, naznačeno time što navedeno antitijelo ili njegov funkcionalni dio sadrže epitop vezujući fragment monoklonalnog antitijela koje se može dobiti iz hibridomskog staničnog niza FP 12H3-C2, deponiranog 1. prosinca 2005. kao DSM ACC2750.
2. Monoklonalno antitijelo ili njegov funkcionalni dio prema zahtjevu 1, naznačeno time što je proizvedeno pomoću hibridomskog staničnog niza FP 12H3-C2, deponiranog 1. prosinca 2005. kao DSM ACC2750.
3. Antitijelo prema bilo kojem od prethodnih zahtjeva ili njegovi funkcionalni dijelovi, naznačeni time što su monoklonalno antitijelo ili himerno antitijelo.
4. Humanizirano antitijelo ili njegov funkcionalni dio, naznačeno time što antitijelo ili njegov funkcionalni dio sadrži komplementarnost određujuće regije (CDR) monoklonalnog antitijela koje se može dobiti iz hibridomskog staničnog niza FP 12H3-C2, deponiranog 1. prosinca 2005. kao DSM ACC2750.
5. Polinukleotid koji sadrži nukleotidnu sekvencu koja kodira antitijelo ili njegov funkcionalni dio prema bilo kojem od zahtjeva 1-4.
6. Stanični niz koji proizvodi antitijelo ili njegov funkcionalni dio prema bilo kojem od zahtjeva 1-4.
7. Stanični niz iz zahtjeva 6, naznačen time što je hibridomski stanični niz FP 12H3-C2, deponiran 1. prosinca 2005. kao DSM ACC2750.
8. Postupak za proizvodnju antitijela ili njegovog funkcionalnog dijela prema bilo kojem od zahtjeva 1-4, naznačen time što obuhvaća uzgajanje (kultiviranje) staničnog niza iz zahtjeva 6 ili 7.
9. Antitijelo ili njegov funkcionalni dio prema bilo kojem od zahtjeva 1-4, naznačeno time što se proizvodi pomoću postupka iz zahtjeva 8.
10. Sastav koja sadrži antitijelo ili njegov funkcionalni dio prema bilo kojem od zahtjeva 1-4, naznačen time što opcijski dalje sadrži farmaceutski prihvatljiv nosač.
11. Sastav prema zahtjevu 10 za primjenu u liječenju bolesti i poremećaja koji su prouzročeni sa ili asocirani sa amiloidom ili amiloidu sličnim proteinima uključujući amiloidozu.
12. Smjesa koja sadrži antitijelo ili njegov funkcionalni dio prema bilo kojem od zahtjeva 1-4, i opcijski, daljnju biološki aktivnu tvar koja se upotrebljava u liječenju bolesti i poremećaja koji su prouzročeni sa ili asocirani sa amiloidom ili amiloidu sličnim proteinima i/ili farmaceutski prihvatljiv nosač i/ili razblaživač i/ili ekscipijent.
13. Primjena antitijela i/ili njegovog funkcionalnog dijela prema bilo kojem od zahtjeva 1-4 i/ili sastava prema bilo kojem od zahtjeva 10 ili 11, ili smjese prema zahtjevu 12 za proizvodnju lijeka za liječenje (tretman) i/ili ublažavanje učinaka amiloidoze, uključujući, ali se ne ograničavajući samo na njih:
(a) neurološke poremećaje kao što je Alzheimerova bolest (AB);
(b) bolesti ili bolesna stanja okarakterizirana gubitkom kapaciteta kognitivne memorije kao što su, na primjer, blago kognitivno pogoršanje (MCI), Lewyjeva tjelesna demencija, Downov sindrom, nasljedna cerebralna hemoragija (izljev krvi u mozak) sa amiloidozom (Nizozemski tip), i Guamov kompleks Parkinsonove demencije; i
(c) progresivnu supranuklearnu (vanmoždanu) paralizu (kap), multiplu sklerozu, Creutzfeld Jacobovu bolest, Parkinsonovu bolest, demenciju u vezi sa HIV-om, ALS (amiotrofičnu lateralnu sklerozu), inkluzijski tjelesni miozitis (IBM), dijabetes melitus odraslih koji ne zavisi od inzulina, senilnu srčanu (kardijakalnu) amiloidozu, endokrine tumore i makularnu degeneraciju (mrlje).
14. Postupak za proizvodnju antitijela i/ili njegovog funkcionalnog dijela prema bilo kojem od zahtjeva 1-4, i/ili kompozicije prema bilo kojem od zahtjeva 10 ili 11, ili smjese prema zahtjevu 12 za primjenu u liječenju (tretmanu) i/ili ublažavanju učinaka amiloidoze, uključujući, ali se ne ograničavajući samo na njih:
(a) neurološke poremećaje kao što je Alzheimerova bolest (AB);
(b) bolesti ili bolesna stanja okarakterizirana gubitkom kapaciteta kognitivne memorije kao što su, na primjer, blago kognitivno pogoršanje (MCI), Lewyjeva tjelesna demencija, Downov sindrom, nasljedna cerebralna hemoragija (izljev krvi u mozak) sa amiloidozom (Nizozemski tip), i Guamov kompleks Parkinsonove demencije; i
(c) progresivnu supranuklearnu (vanmoždanu) paralizu (kap), multiplu sklerozu, Creutzfeld Jacobovu bolest, Parkinsonovu bolest, demenciju u vezi sa HIV-om, ALS (amiotrofičnu lateralnu sklerozu), inkluzijski tjelesni miozitis (IBM), dijabetes melitus odraslih koji ne zavisi od inzulina, senilnu srčanu (kardijakalnu) amiloidozu, endokrine tumore i makularnu degeneraciju (mrlje).
15. Sastav prema zahtjevu 10 ili 11, za primjenu u:
(a) smanjenju tereta plakova (pločica) ili smanjenju količine plakova u mozgu neke životinje, posebno sisavaca, ali naročito humanog bića koje pati od bolesti ili bolesnog stanja asociranih sa amiloidom; ili
(b) smanjenju količine plakova u mozgu neke životinje, posebno sisavaca, ali naročito humanog bića koje pati od bolesti ili bolesnog stanja asociranih sa amiloidom; ili
(c) smanjenju ukupne količine otopinskog Aβ u mozgu neke životinje, posebno sisavaca, ali naročito humanog bića koje pati od bolesti ili bolesnog stanja asociranih sa amiloidom; ili
(d) sprječavanju, liječenju (tretmanu) i/ili ublažavanju učinaka amiloidoze, uključujući, ali se ne ograničavajući samo na njih:
(i) neurološke poremećaje kao što je Alzheimerova bolest (AB);
(ii) bolesti ili bolesna stanja okarakterizirana gubitkom kapaciteta kognitivne memorije kao što su, na primjer, blago kognitivno pogoršanje (MCI), Lewyjeva tjelesna demencija, Downov sindrom, nasljedna cerebralna hemoragija (izljev krvi u mozak) sa amiloidozom (Nizozemski tip), i Guamov kompleks Parkinsonove demencije; i
(iii) progresivnu supranuklearnu (vanmoždanu) paralizu (kap), multiplu sklerozu, Creutzfeld Jacobovu bolest, Parkinsonovu bolest, demenciju u vezi sa HIV-om, ALS (amiotrofičnu lateralnu sklerozu), inkluzijski tjelesni miozitis (IBM), dijabetes melitus odraslih koji ne zavisi od inzulina, senilnu srčanu (kardijakalnu) amiloidozu, endokrine tumore i makularnu degeneraciju (mrlje); ili
(e) očuvanju (zadržavanju) ili povećanju kapaciteta kognitivne memorije u sisavcu koji pokazuje bolest ili bolesno stanje asocirano sa amiloidom.
16. Stanični niz iz zahtjeva 6, naznačen time, što je hibridomski stanični niz.
17. Postupak za dijagnozu bolesti ili bolesnog stanja vezanih sa amiloidom u pacijentu koji obuhvaća detektiranje imunospecifičnog vezivanja antitijela ili njegovog aktivnog fragmenta za epitop amiloidnog proteina u nekom uzorku, koji uključuje slijedeće stupnjeve:
a) dovođenje ovog uzorka na koji se sumnja da sadrži amiloidni antigen u dodir sa antitijelom ili njegovim funkcionalnim dijelom prema bilo kojem od zahtjeva 1-4, pri čemu ovo antitijelo ili njegov funkcionalni dio vezuje epitop ovog amiloidnog proteina;
b) omogućavanje ovom antitijelu ili njegovom funkcionalnom dijelu da se veže za amiloidni antigen tako da se formira imunološki kompleks;
c) detektiranje formiranja ovog imunološkog kompleksa; i
d) koreliranje prisustva ili izostanka ovog imunološkog kompleksa sa prisustvom ili izostankom amiloidnog antigena u ovom uzorku.
18. Postupak za dijagnosticiranje predispozicije za bolest ili bolesno stanje vezane sa amiloidom u nekom pacijentu koji obuhvaća detektiranje imunospecifičnog vezivanja antitijela ili njegovog aktivnog fragmenta za epitop amiloidnog proteina u nekom uzorku, koji uključuje slijedeće stupnjeve:
a) dovođenje ovog uzorka na koji se sumnja da sadrži amiloidni antigen u dodir sa antitijelom ili njegovim funkcionalnim dijelom prema bilo kojem od zahtjeva 1-4, pri čemu ovo antitijelo ili njegov funkcionalni dio vezuje epitop ovog amiloidnog proteina;
b) omogućavanje ovom antitijelu ili njegovom funkcionalnom dijelu da se veže za amiloidni antigen tako da se formira imunološki kompleks;
c) detektiranje formiranja ovog imunološkog kompleksa; i
d) koreliranje prisustva ili izostanka ovog imunološkog kompleksa sa prisustvom ili izostankom amiloidnog antigena u ovom uzorku; i
e) usporedbu količine navedenog imunološkog kompleksa sa normalnom kontrolnom vrijednošću,
pri čemu povećanje u količini navedenog agregata u usporedbi sa normalnom kontrolnom vrijednošću pokazuje da je navedeni pacijent u opasnosti od razvoja bolesti ili bolesnog stanja koji su vezani sa amiloidom.
19. Postupak za monitoriranje minimalne rezidualne bolesti u nekom pacijentu nakon liječenja (tretmana) sa antitijelom ili njegovim funkcionalnim dijelom ili sastavom prema bilo kojem od prethodnih zahtjeva, pri čemu navedeni postupak uključuje slijedeće stupnjeve:
(a) dovođenje ovog uzorka na koji se sumnja da sadrži amiloidni antigen u dodir sa antitijelom ili njegovim funkcionalnim dijelom prema bilo kojem od zahtjeva 1-4, pri čemu ovo antitijelo ili njegov funkcionalni dio vezuje epitop ovog amiloidnog proteina;
(b) omogućavanje antitijelu ili njegovom funkcionalnom dijelu da se veže za amiloidni antigen tako da se formira imunološki kompleks;
(c) detektiranje formiranja ovog imunološkog kompleksa; i
(d) koreliranje (dovođenje u korelaciju) prisustva ili izostanka ovog imunološkog kompleksa sa prisustvom ili izostankom amiloidnog antigena u ovom uzorku; i
(e) usporedbu količine navedenog ili specifičnom dijelu tijela ili površini tijela,
(f) usporedbu količine navedenog imunološkog kompleksa sa normalnom kontrolnom vrijednošću,
pri čemu povećanje u količini navedenog agregata koja je uspoređena sa normalnom kontrolnom vrijednošću pokazuje da navedeni pacijent još pati od minimalne rezidualne bolesti.
20. Postupak za predviđanje prijemčivosti nekog pacijenta koji se liječi (tretira) sa antitijelom ili njegovim funkcionalnim dijelom ili sastavom prema bilo kojem od prethodnih zahtjeva, koji obuhvaća slijedeće stupnjeve:
(a) dovođenje uzorka na koji se sumnja da sadrži amiloidni antigen u dodir sa antitijelom ili njegovim funkcionalnim dijelom prema bilo kojem od zahtjeva 1-4, pri čemu ovo antitijelo ili njegov funkcionalni dio vezuje epitop ovog amiloidnog proteina;
(b) omogućavanje antitijelu da se veže za amiloidni antigen tako da se formira imunološki kompleks;
(c) detektiranje formiranja ovog imunološkog kompleksa; i
(d) koreliranje (dovođenje u korelaciju) prisustva ili izostanka ovog imunološkog kompleksa sa prisustvom ili izostankom amiloidnog antigena u ovom uzorku ili specifičnom dijelu tijela ili površini tijela,
(e) usporedbu količine navedenog imunološkog kompleksa prije i poslije početka liječenja (tretmana),
pri čemu smanjenje u količini navedenog agregata pokazuje da navedeni pacijent ima visok potencijal da bude prijemčiv za ovo liječenje (tretman).
21. Testirajuća oprema za detekciju i dijagnozu bolesti i bolesnih stanja vezanih za amiloid koja obuhvaća antitijela prema bilo kojem od zahtjeva 1-65.
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