HRP20170514T1 - Epitopi sklerostina - Google Patents
Epitopi sklerostina Download PDFInfo
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- HRP20170514T1 HRP20170514T1 HRP20170514TT HRP20170514T HRP20170514T1 HR P20170514 T1 HRP20170514 T1 HR P20170514T1 HR P20170514T T HRP20170514T T HR P20170514TT HR P20170514 T HRP20170514 T HR P20170514T HR P20170514 T1 HRP20170514 T1 HR P20170514T1
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- Prior art keywords
- seq
- bone loss
- disease
- bone
- monoclonal antibody
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- 102000019307 Sclerostin Human genes 0.000 title claims 2
- 108050006698 Sclerostin Proteins 0.000 title claims 2
- 206010065687 Bone loss Diseases 0.000 claims 23
- 101000711796 Homo sapiens Sclerostin Proteins 0.000 claims 13
- 102000058171 human SOST Human genes 0.000 claims 13
- 150000001413 amino acids Chemical class 0.000 claims 12
- 229920001184 polypeptide Polymers 0.000 claims 12
- 102000004196 processed proteins & peptides Human genes 0.000 claims 12
- 108090000765 processed proteins & peptides Proteins 0.000 claims 12
- 239000012634 fragment Substances 0.000 claims 8
- 208000001132 Osteoporosis Diseases 0.000 claims 7
- 125000003275 alpha amino acid group Chemical group 0.000 claims 6
- 210000000988 bone and bone Anatomy 0.000 claims 6
- 201000010099 disease Diseases 0.000 claims 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 5
- 238000000034 method Methods 0.000 claims 5
- 208000029725 Metabolic bone disease Diseases 0.000 claims 4
- 230000029087 digestion Effects 0.000 claims 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims 3
- 206010049088 Osteopenia Diseases 0.000 claims 3
- DTQVDTLACAAQTR-UHFFFAOYSA-N Trifluoroacetic acid Chemical compound OC(=O)C(F)(F)F DTQVDTLACAAQTR-UHFFFAOYSA-N 0.000 claims 3
- 102000004142 Trypsin Human genes 0.000 claims 3
- 108090000631 Trypsin Proteins 0.000 claims 3
- 239000007943 implant Substances 0.000 claims 3
- 239000012588 trypsin Substances 0.000 claims 3
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 2
- 208000027414 Legg-Calve-Perthes disease Diseases 0.000 claims 2
- 241000124008 Mammalia Species 0.000 claims 2
- 206010028980 Neoplasm Diseases 0.000 claims 2
- 206010031264 Osteonecrosis Diseases 0.000 claims 2
- 201000010103 fibrous dysplasia Diseases 0.000 claims 2
- 230000035876 healing Effects 0.000 claims 2
- 229910052500 inorganic mineral Inorganic materials 0.000 claims 2
- 239000011707 mineral Substances 0.000 claims 2
- 208000007056 sickle cell anemia Diseases 0.000 claims 2
- QCVGEOXPDFCNHA-UHFFFAOYSA-N 5,5-dimethyl-2,4-dioxo-1,3-oxazolidine-3-carboxamide Chemical compound CC1(C)OC(=O)N(C(N)=O)C1=O QCVGEOXPDFCNHA-UHFFFAOYSA-N 0.000 claims 1
- 206010000599 Acromegaly Diseases 0.000 claims 1
- 208000007848 Alcoholism Diseases 0.000 claims 1
- 201000000736 Amenorrhea Diseases 0.000 claims 1
- 206010001928 Amenorrhoea Diseases 0.000 claims 1
- 208000000103 Anorexia Nervosa Diseases 0.000 claims 1
- 208000010392 Bone Fractures Diseases 0.000 claims 1
- 208000020084 Bone disease Diseases 0.000 claims 1
- 206010006956 Calcium deficiency Diseases 0.000 claims 1
- 206010008723 Chondrodystrophy Diseases 0.000 claims 1
- 208000013725 Chronic Kidney Disease-Mineral and Bone disease Diseases 0.000 claims 1
- 201000000304 Cleidocranial dysplasia Diseases 0.000 claims 1
- 206010009900 Colitis ulcerative Diseases 0.000 claims 1
- 208000013586 Complex regional pain syndrome type 1 Diseases 0.000 claims 1
- 206010010356 Congenital anomaly Diseases 0.000 claims 1
- 102000012437 Copper-Transporting ATPases Human genes 0.000 claims 1
- 208000011231 Crohn disease Diseases 0.000 claims 1
- 201000003883 Cystic fibrosis Diseases 0.000 claims 1
- 201000010374 Down Syndrome Diseases 0.000 claims 1
- 102000002322 Egg Proteins Human genes 0.000 claims 1
- 108010000912 Egg Proteins Proteins 0.000 claims 1
- 208000000088 Enchondromatosis Diseases 0.000 claims 1
- 208000024720 Fabry Disease Diseases 0.000 claims 1
- 206010017076 Fracture Diseases 0.000 claims 1
- 208000015872 Gaucher disease Diseases 0.000 claims 1
- 102000018997 Growth Hormone Human genes 0.000 claims 1
- 108010051696 Growth Hormone Proteins 0.000 claims 1
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 claims 1
- 208000002972 Hepatolenticular Degeneration Diseases 0.000 claims 1
- 201000002980 Hyperparathyroidism Diseases 0.000 claims 1
- 206010020707 Hyperparathyroidism primary Diseases 0.000 claims 1
- 206010020850 Hyperthyroidism Diseases 0.000 claims 1
- 206010058359 Hypogonadism Diseases 0.000 claims 1
- 208000022559 Inflammatory bowel disease Diseases 0.000 claims 1
- 208000003456 Juvenile Arthritis Diseases 0.000 claims 1
- 208000017670 Juvenile Paget disease Diseases 0.000 claims 1
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims 1
- 208000017924 Klinefelter Syndrome Diseases 0.000 claims 1
- 206010024229 Leprosy Diseases 0.000 claims 1
- 208000002720 Malnutrition Diseases 0.000 claims 1
- 208000001826 Marfan syndrome Diseases 0.000 claims 1
- 208000008948 Menkes Kinky Hair Syndrome Diseases 0.000 claims 1
- 208000012583 Menkes disease Diseases 0.000 claims 1
- 208000002678 Mucopolysaccharidoses Diseases 0.000 claims 1
- 208000034789 Multiple hereditary exostosis Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 102000016943 Muramidase Human genes 0.000 claims 1
- 108010014251 Muramidase Proteins 0.000 claims 1
- 108010062010 N-Acetylmuramoyl-L-alanine Amidase Proteins 0.000 claims 1
- 208000009905 Neurofibromatoses Diseases 0.000 claims 1
- 208000035175 Oligomenorrhea Diseases 0.000 claims 1
- 206010030295 Oligomenorrhoea Diseases 0.000 claims 1
- 206010031243 Osteogenesis imperfecta Diseases 0.000 claims 1
- 206010031252 Osteomyelitis Diseases 0.000 claims 1
- 208000013612 Parathyroid disease Diseases 0.000 claims 1
- 208000010067 Pituitary ACTH Hypersecretion Diseases 0.000 claims 1
- 208000020627 Pituitary-dependent Cushing syndrome Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 201000000981 Primary Hyperparathyroidism Diseases 0.000 claims 1
- 208000002607 Pseudarthrosis Diseases 0.000 claims 1
- 201000001947 Reflex Sympathetic Dystrophy Diseases 0.000 claims 1
- 208000005770 Secondary Hyperparathyroidism Diseases 0.000 claims 1
- 206010041591 Spinal osteoarthritis Diseases 0.000 claims 1
- 208000002903 Thalassemia Diseases 0.000 claims 1
- 208000024799 Thyroid disease Diseases 0.000 claims 1
- 208000026928 Turner syndrome Diseases 0.000 claims 1
- 201000006704 Ulcerative Colitis Diseases 0.000 claims 1
- 206010047623 Vitamin C deficiency Diseases 0.000 claims 1
- 208000018839 Wilson disease Diseases 0.000 claims 1
- 208000008321 Winchester syndrome Diseases 0.000 claims 1
- 208000008919 achondroplasia Diseases 0.000 claims 1
- 208000022567 adolescent idiopathic scoliosis Diseases 0.000 claims 1
- 201000007930 alcohol dependence Diseases 0.000 claims 1
- 231100000540 amenorrhea Toxicity 0.000 claims 1
- 208000007502 anemia Diseases 0.000 claims 1
- 239000001961 anticonvulsive agent Substances 0.000 claims 1
- 238000003556 assay Methods 0.000 claims 1
- 230000033558 biomineral tissue development Effects 0.000 claims 1
- 208000015322 bone marrow disease Diseases 0.000 claims 1
- 230000037118 bone strength Effects 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 238000002512 chemotherapy Methods 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 206010009887 colitis Diseases 0.000 claims 1
- 239000002537 cosmetic Substances 0.000 claims 1
- 230000003111 delayed effect Effects 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 235000014103 egg white Nutrition 0.000 claims 1
- 210000000969 egg white Anatomy 0.000 claims 1
- 238000010828 elution Methods 0.000 claims 1
- 206010015037 epilepsy Diseases 0.000 claims 1
- 210000003054 facial bone Anatomy 0.000 claims 1
- 230000001815 facial effect Effects 0.000 claims 1
- 239000003862 glucocorticoid Substances 0.000 claims 1
- 239000000122 growth hormone Substances 0.000 claims 1
- 229960002897 heparin Drugs 0.000 claims 1
- 229920000669 heparin Polymers 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 238000001794 hormone therapy Methods 0.000 claims 1
- 208000011111 hypophosphatemic rickets Diseases 0.000 claims 1
- 230000004968 inflammatory condition Effects 0.000 claims 1
- 208000027866 inflammatory disease Diseases 0.000 claims 1
- 230000002757 inflammatory effect Effects 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 208000024884 ischemic bone disease Diseases 0.000 claims 1
- 210000003734 kidney Anatomy 0.000 claims 1
- 230000003902 lesion Effects 0.000 claims 1
- 208000019423 liver disease Diseases 0.000 claims 1
- 229960000274 lysozyme Drugs 0.000 claims 1
- 235000010335 lysozyme Nutrition 0.000 claims 1
- 239000004325 lysozyme Substances 0.000 claims 1
- 230000014759 maintenance of location Effects 0.000 claims 1
- 230000001071 malnutrition Effects 0.000 claims 1
- 235000000824 malnutrition Nutrition 0.000 claims 1
- 208000008585 mastocytosis Diseases 0.000 claims 1
- 230000009245 menopause Effects 0.000 claims 1
- 230000001617 migratory effect Effects 0.000 claims 1
- 210000000214 mouth Anatomy 0.000 claims 1
- 206010028093 mucopolysaccharidosis Diseases 0.000 claims 1
- 201000004931 neurofibromatosis Diseases 0.000 claims 1
- 208000015380 nutritional deficiency disease Diseases 0.000 claims 1
- 230000000399 orthopedic effect Effects 0.000 claims 1
- 230000011164 ossification Effects 0.000 claims 1
- 201000008482 osteoarthritis Diseases 0.000 claims 1
- 208000005368 osteomalacia Diseases 0.000 claims 1
- 206010031281 osteopoikilosis Diseases 0.000 claims 1
- 230000035935 pregnancy Effects 0.000 claims 1
- 238000000746 purification Methods 0.000 claims 1
- 201000006409 renal osteodystrophy Diseases 0.000 claims 1
- 238000004007 reversed phase HPLC Methods 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 230000002784 sclerotic effect Effects 0.000 claims 1
- 208000010233 scurvy Diseases 0.000 claims 1
- 210000003625 skull Anatomy 0.000 claims 1
- 208000005801 spondylosis Diseases 0.000 claims 1
- 150000003431 steroids Chemical class 0.000 claims 1
- 208000011580 syndromic disease Diseases 0.000 claims 1
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 210000001685 thyroid gland Anatomy 0.000 claims 1
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/475—Growth factors; Growth regulators
- C07K14/51—Bone morphogenetic factor; Osteogenins; Osteogenic factor; Bone-inducing factor
-
- 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
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Genetics & Genomics (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Zoology (AREA)
- Physical Education & Sports Medicine (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biomedical Technology (AREA)
- Wood Science & Technology (AREA)
- General Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Immunology (AREA)
- Rheumatology (AREA)
- Gastroenterology & Hepatology (AREA)
- Physics & Mathematics (AREA)
- Toxicology (AREA)
- Plant Pathology (AREA)
- Microbiology (AREA)
- Endocrinology (AREA)
- Reproductive Health (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Diaphragms For Electromechanical Transducers (AREA)
Claims (20)
1. Polipeptid koji se sastoji od aminokiselinskih odsječaka SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4 i SEQ ID NO: 5, naznačen time, da su odsječak SEQ ID NO: 2 I odsječak 4 spojeni disulfidnom vezom na aminokiselinskim položajima 57 i 111 s referencom na odsječak SEQ ID NO: 1 a odsječci SEQ ID NO: 3 i 5 su spojeni
(a) disulfidnom vezom na aminokiselinskim položajima 82 i 142 s referencom na odsječak SEQ ID NO: 1, i
(b) disulfidne veze na aminokiselinskim položajima 86 i 144 s referencom na odsječak SEQ ID NO: 1.
2. Polipeptid koji se sastoji od aminokiselinskih odsječaka SEQ ID NO: 70, SEQ ID NO: 71, SEQ ID NO: 72 i SEQ ID NO: 73, naznačen time, da su odsječak SEQ ID NO: 72 i 73 spojeni disulfidnom vezom na aminokiselinskim položajima 57 i 111 s referencom na odsječak SEQ ID NO: 1 a odsječci SEQ ID NO: 70 i 71 su spojeni (a) disulfidnom vezom na aminokiselinskim položajima 82 i 142 s referencom na odsječak SEQ ID NO: 1, i (b) disulfidnom vezom na aminokiselinskim položajima 86 i 144 s referencom na odsječak SEQ ID NO: 1.
3. Polipeptid koji se sastoji od višestruko skraćenog ljudskog proteina sklerostina odsječka SEQ ID NO: 1, naznačen time, da su aminokiseline 1-50, 65-72, 91-100, 118-137 i 150-190 od odsječka SEQ ID NO: 1 odsutne iz rečenog polipeptida te gdje je rečeni polipeptid dobiven triptičnom digestijom ljudskog sklerostina.
4. Polipeptid koji se sastoji od višestruko skraćenog ljudskog proteina sklerostina odsječka SEQ ID NO: 1, naznačen time, da su aminokiseline 1-56, 65-72, 87-110, 118-137 i 145-190 od odsječka SEQ ID NO: 1 odsutne iz rečenog polipeptida te gdje je rečeni polipeptid dobiven triptičnom digestijom ljudskog sklerostina.
5. Polipeptid u skladu patentnim zahtjevom 3 ili 4, naznačen time, da se rečeni ljudski sklerostin tretira s tripsinom, kako bi se postigla potpuna digestija tripsina, a rečeni polipeptid se izolira tekućom kromatografijom visokog učinka (HPLC).
6. Dio ljudskog sklerostina koji se sastoji od aminokiselina 51-64, 73-90, 101-117 i 138-149 odsječka SEQ ID NO: 1, naznačen time, da rečeni dio ima stablo sastavljeno od:
(a) disulfidne veze između aminokiselina 57 i 111;
(b) disulfidne veze između aminokiselina 82 i 142; te
(c) disulfidne veze između aminokiselina 86 i 144.
7. Dio ljudskog sklerostina koji se sastoji od aminokiselina 57-64, 73-86, 111-117 i 138-144 odsječka SEQ ID NO: 1, naznačen time, da rečeni dio ima stablo sastavljeno od:
(a) disulfidne veze između aminokiselina 57 i 111;
(b) disulfidne veze između aminokiselina 82 i 142; te
(c) disulfidne veze između aminokiselina 86 i 144.
8. Postupak proizvodnje dijela ljudskog sklerostina, naznačen time, da se sastoji iz sljedećih koraka:
(a) tretiranja ljudskog sklerostina s tripsinom kako bi se postigla potpuna triptična digestija;
(b) prikupljanja uzorka triptične digestije koja ima prosječnu molekulsku masu od 7122.0D (teorijska masa 7121.5D) ili vrijeme zadržavanja od otprilike 20.6 minuta kako je utvrđeno ispiranjem iz reverzne faze HPLC kolone s ravnim gradijentom od 0.05% trifluoroctene kiseline do 90% acetonitrila u 0.05% TFA pri protoku od 0.2ml/min; i
(c) pročišćavanja rečenog dijela.
9. Neterapijski postupak stvaranja protutijela, naznačen time, da se postupak sastoji od primjene polipeptida kako je definiran u bilo kojem od patentnih zahtjeva 1 do 5 na sisavca.
10. Monoklonsko protutijelo koje se veže za polipeptid prema bilo kojem od patentnih zahtjeva 1 do 5 ili na dio ljudskog sklerostina iz patentnog zahtjeva 6 ili 7, naznačen time, da ima afinitet vezivanja za ljudski sklerostin koji je manji od ili jednak 1 x 10-10.
11. Monoklonsko protutijelo u skladu s patentnim zahtjevom 10, naznačen time, da je fragment F(ab')2, Fab, Fab' ili Fv.
12. Monoklonsko protutijelo u skladu s patentnim zahtjevom 10 ili 11, naznačen time, da je humanizirano protutijelo ili ljudsko protutijelo.
13. Monoklonsko protutijelo u skladu s bilo kojim od patentnih zahtjeva 10 do 12, naznačen time, da se veže za ljudski sklerostin s afinitetom vezanja koji je manji od ili jednak 1x10-10 M ili manji od ili jednak 1 x 10-12 M.
14. Monoklonsko protutijelo u skladu s bilo kojim od patentnih zahtjeva 10 do 12, naznačen time, da se veže za ljudski sklerostin s afinitetom koji je najmanje 50, 100, 250, 500, 1000 ili 10,000 puta veći od afiniteta za lizozim bjelanjka jajeta.
15. Monoklonsko protutijelo u skladu s bilo kojim od patentnih zahtjeva 10 do 14, naznačen time, da se također spaja za petlju 2 epitopa odsječka SEQ ID NO: 6.
16. Monoklonsko protutijelo prema patentnom zahtjevu 10, naznačeno time, da sadrži sljedeće CDR odsječke:
CDR-L1 odsječka SEQ ID NO: 284 CDR-L2 odsječka SEQ ID NO: 285 CDR-L3 odsječka SEQ ID NO: 286 CDR-H1 odsječka SEQ ID NO: 296 CDR-H2 odsječka SEQ ID NO: 297 CDR-H3 odsječka SEQ ID NO: 298.
17. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 10 do 16, naznačen time, da povećava najmanje jednu koštanu formaciju, mineralnu koštanu gustoću, sadržaj minerala u kosti, koštanu masu, kvalitetu kosti i čvrstinu kosti u sisavca ili koja blokira inhibitorni učinak sklerostina u testu mineralizacije koji se temelji na stanici.
18. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 10 do 17, naznačeno time. da se koristi u postupku liječenja osteopenije, osteoporoze ili gubitka kosti uslijed ahondroplazije, kleidokranialne disostoze, enhondromatoze, fibrozne displazije, Gaucherove bolesti, hipofosfatemičnog rahitisa, Marfanovog sindroma, višestruke nasljedne egzostoze, neurofibromatoze, nesavršene osteogeneze, osteopoikilozisa, sklerotične lezije, pseudoartroze, piogenog osteomijelitisa, bolesti usne šupljine, gubitka kosti uzrokovane uzimanjem protu-epileptičnog lijeka, primarne i sekundarne hiperparatiroidoze, sličnih sindroma hiperparatiroidoze, gubitka kosti uslijed bestežinskog stanja, osteoporoze u muškaraca, gubitka kosti nakon menopauze, osteoartritisa, bubrežne osteodistrofije, infiltracijskog poremećaja kosti, gubitka oralne kosti, osteonekroze čeljusti, juvenilne Pagetove bolesti, meloreostoze, metaboličke bolesti kostiju, mastocitoze, sipaste anemije/bolesti, gubitka kosti uslijed usadka, gubitka kosti uslijed usadka bubrega, sistemskog lupusa eritematozusa, ankiloznog spondilitisa, epilepsije, juvenilnog artritisa, talasemije, mukopolisaharidoze, Fabrijeve bolesti, Turnerovog sindroma, Downovog sindroma, Klinefelterovog sindroma, lepre, Perthesove bolesti, adolescentske idiopatske skolioze, početne infantilne višesustavne upalne bolesti, Winchesterovog sindroma, Menkesove bolesti, Wilsonove bolesti, ishemične koštane bolesti (poput primjerice Legg-Calve-Perthesove bolesti, regionalne migratorne osteoporoze), anemičnih stanja, stanja uzrokovanih steroidima, gubitka kosti izazvane glukokortikoidima, gubitka kosti izazvane heparinom, poremećaja koštane srži, skorbuta, pothranjenosti, nedostatka kalcija, idiopatske osteopcnije ili osteoporoze, kongenitalne osteopenije ili osteoporoze, alkoholizma, kronične bolesti jetre, stanja poslije menopauze, kroničnih upalnih stanja, reumatoidnog artritisa, upalnih bolesti crijeva, ulceroznog kolitisa, upalnog kolitisa, Crohnove bolesti, oligomenoreje, amenoreje, trudnoće, šećerne bolesti, hipcrtiroidizma, poremećaja štitnjače, paratiroidnih poremećaja, Cushingove bolesti, akromegalije, hipogonadizma, nepokretljivosti ili neuporabe, sindroma refleksne simpatetičke distrofije, regionalne osteoporoze, osteomalacijc, gubitka kosti povezane sa zamjenom zgloba, gubitka kosti povezane s HlV-om, gubitka kosti povezane s hormonom rasta, gubitka kosti povezane s cističnom fibrozom, fibrozne displazije, gubitka kosti povezane s kemoterapijom, gubitka kosti izazvane tumorom, gubitka kosti povezane s karcinomom, gubitka kosti zbog ablativne hormonske terapije, višestrukog mijeloma, gubitkom kosti uslijed uzimanja lijekova, anoreksije nervoza, gubitka kostiju lica uslijed bolesti, gubitka kranijalne kosti uslijed bolesti, gubitka čeljusne kosti uslijed bolesti, gubitka kosti lubanje uslijed bolesti ili gubitka kosti uslijed putovanja u svemir.
19. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 10 do 17, naznačeno time, da se koristi za liječenje osteoporoze ili osteopenije.
20. Monoklonsko protutijelo prema bilo kojem od patentnih zahtjeva 10 do 17, naznačeno time, da se koristi u postupku poboljšanja ishoda kod ortopedskih zahvata, dentalnih zahvata, operacija usadka, zamjene zgloba, presađivanja kosti, kozmetičke operacije kosti i reparacije poput liječenja lomova, zacjeljivanja bez srastanja, zakašnjelog zacjeljivanja bez srastanja ili rekonstrukcije lica.
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