HRP20160872T1 - Postupak za inhibiciju resorpcije kosti - Google Patents

Postupak za inhibiciju resorpcije kosti Download PDF

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Publication number
HRP20160872T1
HRP20160872T1 HRP20160872TT HRP20160872T HRP20160872T1 HR P20160872 T1 HRP20160872 T1 HR P20160872T1 HR P20160872T T HRP20160872T T HR P20160872TT HR P20160872 T HRP20160872 T HR P20160872T HR P20160872 T1 HRP20160872 T1 HR P20160872T1
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Croatia
Prior art keywords
antibody
bone loss
seq
fragment
disease
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HRP20160872TT
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English (en)
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Ian Desmond Padhi
Graham Richard Jang
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Amgen, Inc
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Application filed by Amgen, Inc filed Critical Amgen, Inc
Publication of HRP20160872T1 publication Critical patent/HRP20160872T1/hr

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    • CCHEMISTRY; METALLURGY
    • 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
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/08Antiepileptics; Anticonvulsants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/30Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/32Alcohol-abuse
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • A61P31/08Antibacterial agents for leprosy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Claims (13)

1. Protutijelo protiv sklerostina ili njegov fragment koji se koristi u postupku za inhibiranje resorpcije kosti kod čovjeka, postupak uključuje davanje navedenog protutijela protiv sklerostina ili njegovog fragmenta čovjeku u količini od 1 mg/kg do 5 mg/kg, naznačeno time, da protutijelo protiv sklerostina ili njegov fragment pokazuje afinitet vezanja na sklerostin SEQ ID NO: 1 koji je manji ili jednak 1 x 10-7M i poprečno blokira vezanje na sklerostin protutijela koje sadržava CDR SEQ ID br. 245, 246, 247, 78, 79 i 80 ili CDR SEQ ID br. 284, 285, 286, 296, 297 i 298, ili je poprečno blokirano protiv vezivanja na sklerostin navedenim protutijelom, pri čemu je: - SEQ ID No:245 = Asp Tyr Asn Met His; - SEQ ID No:246 = Glu Ile Asn Pro Asn Ser Gly Gly Ala Gly Tyr Asn Gln Lys Phe Lys Gly; - SEQ ID No:247 = Leu Gly Tyr Asp Asp Ile Tyr Asp Asp Trp Tyr Phe Asp Val; - SEQ ID No: 78 = Arg Ala Ser Gln Asp Ile Ser Asn Tyr Leu Asn; - SEQ ID No: 79 = Tyr Thr Ser Arg Leu Leu Ser; i - SEQ ID No: 80 = Gln Gln Gly Asp Thr Leu Pro Tyr Thr; i - SEQ ID NO: 284 = Arg Ala Ser Ser Ser Val Thr Ser Ser Tyr Leu Asn; - SEQ ID NO: 285 = Ser Thr Ser Asn Leu Ala Ser; - SEQ ID NO: 286 = Gln Gln Tyr Asp Phe Phe Pro Ser Thr; - SEQ ID NO: 296 = Asp Tyr Tyr Met Asn; - SEQ ID NO: 297 = Asp He Asn Pro Tyr Asn Asp Asp Thr Thr Tyr Asn His Lys Phe Lys Gly i - SEQ ID NO 298 = Glu Thr Ala Val He Thr Thr Asn Ala Met Asp.
2. Protutijelo ili fragment za upotrebu u skladu s patentnim zahtjevom 1, naznačeno time, da je količina protutijela protiv sklerostina koja se primjenjuje od 1 mg/kg do 3 mg/kg.
3. Protutijelo ili fragment za upotrebu u skladu s patentnim zahtjevom 1 ili 2, naznačeno time, da je količina protutijela protiv sklerostina koja se primjenjuje oko 2 mg/kg.
4. Protutijelo ili fragment za upotrebu u skladu s patentnim zahtjevom 1 ili 2, naznačeno time, da je količina protutijela protiv sklerostina koja se primjenjuje oko 3 mg/kg.
5. Protutijelo ili fragment za upotrebu u skladu s patentnim zahtjevom 1, naznačeno time, da postupak obuhvaća davanje protutijela protiv sklerostina čovjeku u dozi od 70 do 450 mg.
6. Protutijelo ili fragment za upotrebu u skladu s patentnim zahtjevom 1, naznačeno time, da postupak obuhvaća davanja doze od oko 140 mg.
7. Protutijelo ili fragment za upotrebu u skladu s patentnim zahtjevom 1, naznačeno time, da postupak obuhvaća davanja doze od oko 210 mg.
8. Protutijelo ili fragment za upotrebu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da se količina protutijela protiv sklerostina subjektu daje jednom svaka dva tjedna.
9. Protutijelo ili fragment za upotrebu u skladu s bilo kojim od zahtjeva 1 do 7, naznačeno time, da se protutijelo protiv sklerostina subjektu daje jednom mjesečno.
10. Protutijelo ili fragment za upotrebu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da je protutijelo humano protutijelo, humanizirano protutijelo, monoklonalno protutijelo ili himerno protutijelo.
11. Protutijelo ili fragment za upotrebu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da osoba pati od poremećaja povezanih s kostima odabranih iz skupine koju čine: ahondroplazija, kleidocranijalna disostoza, enhondromatoza, fibrozna displazija, Gaucherova bolest, hipofosfatemični rahitis, Marfanov sindrom, multipla nasljedna egzostoza, neurofibromatoza, osteogenesis imperfecta, osteoporoza, osteopoikilosis, sklerostične lezije, pseudoartroza, piogeni osteomijelitis, parodontna bolest, gubitak kosti induciran lijekovima protiv epilepsije, primarni i sekundarni hiperparatiroidizam, sindrom obiteljskog hiperparatiroidizma, gubitak kosti induciran bestežinskim stanjem, osteoporoza u muškaraca, gubitak koštane mase u postmenopauzi, osteoartritis, bubrežna osteodistrofija, infiltrativni poremećaji kosti, oralni gubitak kosti, osteonekroza čeljusti, juvenilna Pagetova bolest, melorheostoza, metaboličke bolesti kostiju, mastocitoza, anemija/bolest srpastih stanica, gubitak kosti povezan s presađivanjem organa, gubitak kosti uslijed transplantacije bubrega, sistemski eritemski lupus, ankilozni spondilitis, epilepsija, juvenilni artritis, talasemija, mucopolysaccharidoses, Fabrijeva bolest, Turnerov sindrom, Downov sindrom, Klinefelterov sindrom, lepra, Perthesova bolest, idiopatska skolioza adolescenata, multisistemska upalna bolest novorođenčeta, Winchester sindrom, Menkesova bolest, Wilsonova bolest, ishemijske bolesti kostiju, Legg - Calve - Perthesova bolest, regionalna migracijska osteoporoza, anemična stanja, stanja uzrokovana steroidima, gubitak koštane mase izazvan glukokortikoidima, gubitak koštane mase izazvan heparinom, poremećaj koštane srži, skorbut, pothranjenost, nedostatak kalcija, osteoporoza, osteopenija, alkoholizam, kronična bolest jetre, stanja u post-menopauzi, kronična upalna stanja, reumatoidni artritis, upalne bolesti crijeva, ulcerozni kolitis, upalni kolitis, Crohnova bolest, oligomenoreja, amenoreja, trudnoća, dijabetes melitus, hipertireoza, poremećaji štitnjače, poremećaji nusštitnjače, Cushingova bolest, akromegalija, hipogonadizam, imobilizacija ili neaktivnost, refleksna simpatička distrofija, regionalna osteoporoza, osteomalacija, gubitak kosti povezan sa instalacijom umjetnog zgloba, gubitak koštane mase povezan s HlV-om, gubitak kosti povezan sa nedostatkom hormona rasta, gubitak koštane mase povezan s cističnom fibrozom, gubitak koštane mase povezan s kemoterapijom, gubitak kosti uslijed tumora, gubitak koštane mase povezan s rakom, gubitak kosti povezan sa uklanjanjem organa koji izlučuju hormone, multipli mijelom, gubitak kosti induciran lijekovima, anoreksijska nervoza, bolesti povezane s gubitkom kosti lica, bolesti povezane s gubitkom kranijalnih kosti, bolesti povezane s gubitkom čeljustnih kosti, gubitak koštane mase povezan s bolestima lubanje, gubitak koštane mase povezan sa starenjem, gubitak kosti lica povezan sa starenjem, gubitak kranijalnih kosti povezan sa starenjem, gubitak kosti čeljusti povezan sa starenjem, gubitak kosti povezan sa starenjem lubanje i gubitak kosti povezan sa svemirskim putovanjima.
12. Protutijelo ili fragment za upotrebu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da je osoba žena nakon menopauze.
13. Protutijelo ili fragment za upotrebu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da osoba pati od osteoporoze.
HRP20160872TT 2007-09-17 2016-07-14 Postupak za inhibiciju resorpcije kosti HRP20160872T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US97302407P 2007-09-17 2007-09-17
EP12180292.0A EP2556841B9 (en) 2007-09-17 2008-09-17 Method for inhibiting bone resorption

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HRP20160872T1 true HRP20160872T1 (hr) 2016-09-23

Family

ID=40371592

Family Applications (3)

Application Number Title Priority Date Filing Date
HRP20140153AT HRP20140153T1 (hr) 2007-09-17 2014-02-18 Anti-sklerostin antitijela
HRP20160872TT HRP20160872T1 (hr) 2007-09-17 2016-07-14 Postupak za inhibiciju resorpcije kosti
HRP20201438TT HRP20201438T1 (hr) 2007-09-17 2020-09-09 Metoda inhibiranja resorpcije kosti

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HRP20140153AT HRP20140153T1 (hr) 2007-09-17 2014-02-18 Anti-sklerostin antitijela

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20201438TT HRP20201438T1 (hr) 2007-09-17 2020-09-09 Metoda inhibiranja resorpcije kosti

Country Status (21)

Country Link
US (7) US8017120B2 (hr)
EP (5) EP2195026B1 (hr)
JP (2) JP5643094B2 (hr)
AR (2) AR068471A1 (hr)
AU (1) AU2008302313C1 (hr)
CA (2) CA2699905C (hr)
CL (1) CL2008002775A1 (hr)
CY (3) CY1114961T1 (hr)
DK (4) DK3725329T3 (hr)
ES (3) ES2815677T3 (hr)
FI (1) FI3725329T3 (hr)
HK (1) HK1182017A1 (hr)
HR (3) HRP20140153T1 (hr)
HU (2) HUE050653T2 (hr)
LT (3) LT2556841T (hr)
MX (1) MX2010002971A (hr)
PL (3) PL3085386T3 (hr)
PT (4) PT3085386T (hr)
SI (3) SI3085386T1 (hr)
TW (2) TWI526222B (hr)
WO (1) WO2009039175A2 (hr)

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