DK1704166T3 - M-csf-specifikt monoklonalt antistof og anvendelser deraf - Google Patents

M-csf-specifikt monoklonalt antistof og anvendelser deraf Download PDF

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DK1704166T3
DK1704166T3 DK05711308.6T DK05711308T DK1704166T3 DK 1704166 T3 DK1704166 T3 DK 1704166T3 DK 05711308 T DK05711308 T DK 05711308T DK 1704166 T3 DK1704166 T3 DK 1704166T3
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antibody
cancer
csf
antibodies
human
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DK05711308.6T
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Arnold H Horwitz
Cheng Liu
Deborah Lee Zimmerman
Kirston Koths
William Michael Kavanaugh
Li Long
Maria Calderon-Cacia
Gregory Martin Harrowe
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Novartis Vaccines & Diagnostic
Xoma Technology Ltd
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    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
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    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
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    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
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    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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    • C07K2317/54—F(ab')2
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Claims (18)

1. Humaniseret anti-M-CSF-antistof, hvor: (i) den tunge kæde omfatter den tunge kæde variable regionsekvens som vist i SEQ ID NO: 43 og en IgGl-konstant region; og (ii) den lette kæde omfatter den lette kæde variable regionsekvens som vist i SEQ ID NO: 53.
2. Antistoffet ifølge krav 1 omfattende den tunge kæde sekvens som vist i SEQ ID NO: 116.
3. Antistoffet ifølge krav 1 eller krav 2, hvor den lette kæde omfatter en human kappa-konstant region.
4. Farmaceutisk sammensætning omfattende et antistof som defineret i et hvilket som helst af kravene 1-3, og en farmaceutisk egnet bærer, excipiens eller diluent.
5. Et antistof som defineret i et hvilket som helst af kravene 1-3, til anvendelse i terapeutiske applikationer der involverer in v/Vo-administration til et menneske.
6. Antistoffet ifølge et hvilket som helst af kravene 1-3 til anvendelse i forebyggelse eller behandling af et individ ramt af en sygdom der forårsager eller bidrager til osteolyse, hvor antistoffet effektivt nedsætter alvorligheden af knogletab forbundet med sygdommen.
7. Antistoffet til anvendelse ifølge krav 6, hvor sygdommen er valgt fra gruppen bestående af metaboliske knoglesygdomme forbundet med relativt forøget osteoklastaktivitet, herunder endokrinopatier (herunder hypercortisolisme, hypogonadisme, primær eller sekundær hyperparathyroidisme, hyperthyroidisme), hypercalcæmi, mangeltilstande (herunder engelsk syge/osteomalaci, skørbug, fejlernæring), kroniske sygdomme (herunder malabsorption syndromer, kronisk nyresvigt (herunder renal osteodystrophi), kronisk leversygdom (herunder hepatisk osteodystrophi)), lægemidler (herunder glucocorticoider (glucocorticoid-induceret osteoporose), heparin, alkohol), and arvelige sygdomme (herunder osteogenese imperfecta, homocystinuri), cancer, osteoporose, osteopetrose, knogleinflammation forbundet med arthritis og rheumatoid arthritis, periodontal sygdom, fibrøs dysplasi, og/eller Paget's sygdom.
8. Antistoffet som defineret i et hvilket som helst af kravene 1-3 til anvendelse i forebyggelse eller behandling af metastatisk cancer til knogler, hvor den metastatiske cancer er bryst, lunge, nyre, multipel myelom, thyroid, prostata, adenocarcinom, blodcelleondartetheder, herunder leukæmi eller lymfom; hoved- og halscancer; fordøjelseskanalcancer, herunder øsofageal cancer, mavecancer, tyktarmscancer, tyndtarmscancer, kolorektal cancer, rektal cancer, bugspytkirtelcancer, levercancer, cancer i galdevejene eller galdeblæren; ondartede svulster i den kvindelige genitaltragt herunder ovariecarcinom, livmoder-endometriecancere, vaginal cancer, eller cervical cancer; blærecancer; hjernecancer, herunder neuroblastom; sarcom, osteosarcom; eller hudcancer, herunder malignt melanom eller skvamøs cellecancer.
9. Anvendelse af antistoffet som defineret i et hvilket som helst af kravene 1-3 i fremstillingen af et medikament til forebyggelse eller nedsættelse af knogletab hos en patient der udviser osteolyse.
10. Anvendelse af antistoffet som defineret i et hvilket som helst af kravene 1-3 i fremstillingen af et medikament til behandling af en patient ramt af en sygdom der forårsager eller bidrager til osteolyse.
11. Anvendelsen ifølge krav 10 hvor sygdommen er valgt fra gruppen bestående af metaboliske knoglesygdomme forbundet med relativt forøget osteoklastaktivitet, herunder endokrinopatier (herunder hypercortisolisme, hypogonadisme, primær eller sekundær hyperparathyroidisme, hyperthyroidisme), hypercalcæmi, mangeltilstande (herunder engelsk syge/osteomalaci, skørbug, fejlernæring), kroniske sygdomme (herunder malabsorptionssyndromer, kronisk nyresvigt (herunder nyreosteodystrofi), kronisk leversygdom (herunder hepatisk osteodystrofi)), lægemidler (herunder glucocorticoider (glucocorticoid-induceret osteoporose), heparin, alkohol), og arvelige sygdomme (herunder osteogenese imperfecta, homocystinuri), cancer, osteoporose, osteopetrose, inflammation eller knogler forbundet med arthritis og rheumatoid arthritis, periodontal sygdom, fibrøs dysplasi, og/eller Paget's sygdom.
12. Anvendelse af antistoffet som defineret i et hvilket som helst af kravene 1-3 i fremstillingen af et medikament til forebyggelse eller behandling af metastatisk cancer til knogler hos en patient der lider af metastatisk cancer.
13. Anvendelsen ifølge krav 12, hvor den metastatiske cancer er bryst, lunge, nyre, multipel myelom, thyroid, prostata, adenocarcinom, blodcelleondartetheder, herunder leukæmi eller lymfom; hoved- og halscancer; fordøjelseskanalcancere, herunder øsofagealcancer, mavecancer, tyktarmscancer, tyndtarmscancer, colorektalcancer, rektalcancer, bugspytkirtelcancer, levercancer, cancer i galdevejene eller galdeblæren; ondartede svulster i den kvindelige genitaltragt herunder ovariecarcinom, livmoder- endometriecancere, vaginalcancer, eller cervicalcancer; blærecancer; hjernecancer, herunder neuroblastom; sarcom, osteosarcom; eller hudcancer, herunder malignt melanom eller skvamøs cellecancer.
14. Anvendelse af antistoffet som defineret i et hvilket som helst af kravene 1-3 i fremstillingen af et medikament til behandling af en patient med cancer.
15. Anvendelse ifølge et hvilket som helst af kravene 9-14, hvor mængden af antistoffet i medikamentet er effektivt til at inhibere osteoklast-proliferation og/eller differentiering induceret af tumorcellerne.
16. Anvendelse ifølge et hvilket som helst af kravene 9-14, hvor mængden af antistoffet i medikamentet er ved en dosis der er effektiv til at nedsætte doseringen af andet terapeutisk middel der kræves til at opnå en terapeutisk virkning.
17. Anvendelse ifølge et hvilket som helst af kravene 9-14, hvor mængden af antistoffet i medikamentet er ved en dosis mellem ca. 2 pg/kg til 30 mg/kg legemsvægt.
18. Anvendelsen ifølge krav 17, hvor mængden af antistoffet i medikamentet er ved en dosis mellem ca. 0,1 mg/kg til 30 mg/kg legemsvægt, eller hvor mængden af antistoffet i medikamentet er ved en dosis mellem ca. 0,1 mg/kg til 10 mg/kg legemsvægt.
DK05711308.6T 2004-01-07 2005-01-06 M-csf-specifikt monoklonalt antistof og anvendelser deraf DK1704166T3 (da)

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