HRP20140161T1 - Sastavi i postupci za uporabu protutijela protiv sklerostina - Google Patents

Sastavi i postupci za uporabu protutijela protiv sklerostina Download PDF

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HRP20140161T1
HRP20140161T1 HRP20140161AT HRP20140161T HRP20140161T1 HR P20140161 T1 HRP20140161 T1 HR P20140161T1 HR P20140161A T HRP20140161A T HR P20140161AT HR P20140161 T HRP20140161 T HR P20140161T HR P20140161 T1 HRP20140161 T1 HR P20140161T1
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sclerostin
antibody
bone loss
pathological disorder
osteonecrosis
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HRP20140161AT
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Michaela Kneissel
Christine Halleux
Shou-Ih Hu
Beate Diefenbach-Streiber
Josef Prassler
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Novartis Ag
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    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
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    • G01N2333/51—Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
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Claims (29)

1. Protutijelo protiv sklerostina, naznačeno time, da obuhvaća polipeptidnu sekvencu varijabilnog područja jakog lanca, koja sadrži SEQ ID NO: 70 i polipeptidnu sekvencu varijabilnog područja slabog lanca, koja sadrži SEQ ID NO: 81.
2. Protutijelo prema zahtjevu 1, naznačeno time, da obuhvaća aminokiselinsku sekvencu pune duljine jakog lanca, koja sadrži SEQ ID NO: 114.
3. Protutijelo prema bilo kojem od zahtjeva 1 do 2, naznačeno time, da obuhvaća aminokiselinsku sekvencu pune duljine slabog lanca, koja sadrži SEQ ID NO: 125.
4. Protutijelo, naznačeno time, da obuhvaća sekvencu jakog lanca od SEQ ID NO: 114 i sekvencu slabog lanca od SEQ ID NO: 125.
5. Protutijelo prema bilo kojem od zahtjeva 1 do 4, naznačeno time, da se upotrebljava kao lijek.
6. Uporaba protutijela prema bilo kojem od zahtjeva 1 do 4, naznačena time, da je za proizvodnju lijeka za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu je patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
7. Protutijelo prema bilo kojem od zahtjeva 1 do 4, naznačeno time, da se upotrebljava za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu je patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
8. Farmaceutski sastav, naznačen time, da obuhvaća protutijelo prema bilo kojem od zahtjeva 1 do 4.
9. Farmaceutski sastav prema zahtjevu 8, naznačen time, da je u kombinaciji s jednim ili više farmaceutski prihvatljivim pomoćnim sredstvom, razrjeđivačem ili nosačem.
10. Farmaceutski sastav prema zahtjevu 8 ili 9, naznačen time, da dodatno obuhvaća ostale aktivne sastojke.
11. Farmaceutski sastav prema zahtjevu 8 ili 9, naznačen time, da dodatno obuhvaća barem jedno sljedeće protuupalno ili anti-osteoporozno sredstvo.
12. Izolirana polinukleotidna sekvenca, naznačena time, da kodira protutijelo prema bilo kojem od zahtjeva 1 do 4.
13. Vektor kloniranja ili vektor ekspresije, naznačen time, da obuhvaća jednu ili više polinukleotidnih sekvenci prema zahtjevu 12.
14. Vektor prema zahtjevu 13, naznačen time, da taj vektor obuhvaća barem jednu sekvencu nukleinske kiseline odabranu iz skupine koju čine SEQ ID NO: 136 i SEQ ID NO: 147.
15. Stanica domaćina, naznačena time, da obuhvaća jedan ili više vektora kloniranja ili vektora ekspresije prema zahtjevima 13 do 14.
16. Postupak proizvodnje protutijela prema bilo kojem od zahtjeva 1 do 4, naznačen time, da obuhvaća kultivaciju stanice domaćina prema zahtjevu 15 i izolaciju spomenutog protutijela.
17. Protutijelo prema bilo kojem od zahtjeva 1 do 4, ili farmaceutski sastav prema bilo kojem od zahtjeva 8 do 11, naznačen(o) time, da se upotrebljava za liječenje ili profilaksu patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu je patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
18. Dijagnostička garnitura, naznačena time, da sadrži protutijelo prema bilo kojem od zahtjeva 1 do 4.
19. Postupak in vitro identifikacije stanice ili tkiva koja/e izražava sklerostin, naznačen time, da taj postupak obuhvaća stavljanje u doticaj spomenute stanice ili tkiva s protutijelom prema bilo kojem od zahtjeva 1 do 4, pri čemu spomenuto protutijelo nadalje obuhvaća prepoznatljivu oznaku, kao što je radioaktivna oznaka, fluorescentna oznaka, magnetna oznaka, paramagnetna oznaka ili kemijsko-iluminacijska oznaka.
20. Uporaba protutijela prema bilo kojem od zahtjeva 1 do 4 te (i) zoledronske kiseline, (ii) protutijela anti-DKK1, (iii) alendronata, (iv) protutijela anti-LRP4, (v) sredstava za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, naznačena time, da je za proizvodnju lijeka za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu je patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
21. Uporaba protutijela prema bilo kojem od zahtjeva 1 do 4, naznačena time, da je za proizvodnju lijeka za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu se lijek upotrebljava u sjedinjenju s (i) zoledronskom kiselinom, (ii) protutijelom anti-DKK1, (iii) alendronatom, (iv) protutijelom anti-LRP4, (v) sredstvima za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, te da je pritom patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
22. Uporaba (i) zoledronske kiseline, (ii) protutijela anti-DKK1, (iii) alendronata, (iv) protutijela anti-LRP4, (v) sredstava za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, naznačena time, da je za proizvodnju lijeka za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu se lijek upotrebljava u sjedinjenju s protutijelom prema bilo kojem od zahtjeva 1 do 4, te da je pritom patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
23. Uporaba protutijela prema bilo kojem od zahtjeva 1 do 4, naznačena time, da je za proizvodnju lijeka za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu se pacijentu prethodno daju (i) zoledronska kiselina, (ii) protutijelo anti-DKK1, (iii) alendronat, (iv) protutijelo anti-LRP4, (v) sredstva za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, te da je pritom patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
24. Uporaba (i) zoledronske kiseline, (ii) protutijela anti-DKK1, (iii) alendronata, (iv) protutijela anti-LRP4, (v) sredstava za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, naznačena time, da je za proizvodnju lijeka za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu se pacijentu prethodno daje protutijelo prema bilo kojem od zahtjeva 1 do 4, te da je pritom patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
25. Protutijelo prema bilo kojem od zahtjeva 1 do 4, te (i) zoledronska kiselina, (ii) protutijelo anti-DKK1, (iii) alendronat, (iv) protutijelo anti-LRP4, (v) sredstva za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, naznačeni time, da se upotrebljavaju za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu je patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
26. Protutijelo prema bilo kojem od zahtjeva 1 do 4, koje se upotrebljava u sjedinjenju s (i) zoledronskom kiselinom, (ii) protutijelom anti-DKK1, (iii) alendronatom, (iv) protutijelom anti-LRP4, (v) sredstvima za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, naznačeno time, da se upotrebljava za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu je patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
27. Protutijelo prema bilo kojem od zahtjeva 1 do 4, naznačeno time, da se upotrebljava za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu se pacijentu prethodno daju (i) zoledronska kiselina, (ii) protutijelo anti-DKK1, (iii) alendronat, (iv) protutijelo anti-LRP4, (v) sredstva za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, te da je pritom patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
28. (i) Zoledronska kiselina, (ii) protutijelo anti-DKK1, (iii) alendronat, (iv) protutijelo anti- LRP4, (v) sredstva za oslobađanje hormona hPTH i/ili (vi) paratiroidnog hormona kao što su kalcilitici, naznačeni time, da se upotrebljavaju za liječenje patološkog poremećaja koji je posredovan sklerostinom ili je povezan s povećanjem razine sklerostina, pri čemu se pacijentu prethodno daje protutijelo prema bilo kojem od zahtjeva 1 do 4, te da je pritom patološki poremećaj barem jedan od sljedećih: primarna i sekundarna osteoporoza, osteopenija, osteomalacija, osteogenesis imperfecta, vaskularna nekroza također poznata pod nazivom osteonekroza, frakture i zacjeljivanje implantatima uključujući dentalne implantate i implantate za kuk, gubitak kostiju zbog ostalih poremećaja kao što je gubitak kostiju povezan s HIV-infekcijom, rakom ili artritisom.
29. Uporaba prema bilo kojem od zahtjeva 20 do 28, naznačena time, da hPTH je hPTH(1-34).
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