HRP20220057T1 - Varijante natriuretičnog peptida c-tipa - Google Patents
Varijante natriuretičnog peptida c-tipa Download PDFInfo
- Publication number
- HRP20220057T1 HRP20220057T1 HRP20220057TT HRP20220057T HRP20220057T1 HR P20220057 T1 HRP20220057 T1 HR P20220057T1 HR P20220057T T HRP20220057T T HR P20220057TT HR P20220057 T HRP20220057 T HR P20220057T HR P20220057 T1 HRP20220057 T1 HR P20220057T1
- Authority
- HR
- Croatia
- Prior art keywords
- cnp variant
- dysplasia
- cnp
- taf12
- fusion polypeptide
- Prior art date
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- 102000012421 C-Type Natriuretic Peptide Human genes 0.000 title claims 20
- 101800000060 C-type natriuretic peptide Proteins 0.000 title claims 20
- 108090000765 processed proteins & peptides Proteins 0.000 claims 12
- 101000788172 Homo sapiens Transcription initiation factor TFIID subunit 12 Proteins 0.000 claims 10
- 102100025171 Transcription initiation factor TFIID subunit 12 Human genes 0.000 claims 10
- 229920001184 polypeptide Polymers 0.000 claims 8
- 102000004196 processed proteins & peptides Human genes 0.000 claims 8
- 230000004927 fusion Effects 0.000 claims 7
- 238000003776 cleavage reaction Methods 0.000 claims 6
- BDAGIHXWWSANSR-UHFFFAOYSA-N methanoic acid Natural products OC=O BDAGIHXWWSANSR-UHFFFAOYSA-N 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- 102000004169 proteins and genes Human genes 0.000 claims 6
- 108090000623 proteins and genes Proteins 0.000 claims 6
- 230000007017 scission Effects 0.000 claims 6
- 229920001477 hydrophilic polymer Polymers 0.000 claims 5
- 239000003795 chemical substances by application Substances 0.000 claims 4
- 208000011580 syndromic disease Diseases 0.000 claims 4
- OSWFIVFLDKOXQC-UHFFFAOYSA-N 4-(3-methoxyphenyl)aniline Chemical compound COC1=CC=CC(C=2C=CC(N)=CC=2)=C1 OSWFIVFLDKOXQC-UHFFFAOYSA-N 0.000 claims 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 3
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 3
- 206010008723 Chondrodystrophy Diseases 0.000 claims 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- 235000019253 formic acid Nutrition 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 108091033319 polynucleotide Proteins 0.000 claims 3
- 102000040430 polynucleotide Human genes 0.000 claims 3
- 239000002157 polynucleotide Substances 0.000 claims 3
- 206010058314 Dysplasia Diseases 0.000 claims 2
- 206010019280 Heart failures Diseases 0.000 claims 2
- 206010030113 Oedema Diseases 0.000 claims 2
- 206010031243 Osteogenesis imperfecta Diseases 0.000 claims 2
- 239000002202 Polyethylene glycol Substances 0.000 claims 2
- 208000008919 achondroplasia Diseases 0.000 claims 2
- 150000001413 amino acids Chemical group 0.000 claims 2
- 210000004027 cell Anatomy 0.000 claims 2
- 208000017568 chondrodysplasia Diseases 0.000 claims 2
- ATDGTVJJHBUTRL-UHFFFAOYSA-N cyanogen bromide Chemical compound BrC#N ATDGTVJJHBUTRL-UHFFFAOYSA-N 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- 201000010072 hypochondroplasia Diseases 0.000 claims 2
- 231100000518 lethal Toxicity 0.000 claims 2
- 230000001665 lethal effect Effects 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 229920001223 polyethylene glycol Polymers 0.000 claims 2
- 208000009304 Acute Kidney Injury Diseases 0.000 claims 1
- 206010003210 Arteriosclerosis Diseases 0.000 claims 1
- 101150061927 BMP2 gene Proteins 0.000 claims 1
- 102100026189 Beta-galactosidase Human genes 0.000 claims 1
- 108010049931 Bone Morphogenetic Protein 2 Proteins 0.000 claims 1
- 102100024506 Bone morphogenetic protein 2 Human genes 0.000 claims 1
- 101000708016 Caenorhabditis elegans Sentrin-specific protease Proteins 0.000 claims 1
- 208000009447 Cardiac Edema Diseases 0.000 claims 1
- 206010007559 Cardiac failure congestive Diseases 0.000 claims 1
- 229920002101 Chitin Polymers 0.000 claims 1
- 206010010356 Congenital anomaly Diseases 0.000 claims 1
- 206010013883 Dwarfism Diseases 0.000 claims 1
- 108010013369 Enteropeptidase Proteins 0.000 claims 1
- 102100029727 Enteropeptidase Human genes 0.000 claims 1
- 108010074860 Factor Xa Proteins 0.000 claims 1
- 208000016264 Femoral agenesis/hypoplasia Diseases 0.000 claims 1
- 102000005720 Glutathione transferase Human genes 0.000 claims 1
- 108010070675 Glutathione transferase Proteins 0.000 claims 1
- 108010033040 Histones Proteins 0.000 claims 1
- AVXURJPOCDRRFD-UHFFFAOYSA-N Hydroxylamine Chemical compound ON AVXURJPOCDRRFD-UHFFFAOYSA-N 0.000 claims 1
- 206010020772 Hypertension Diseases 0.000 claims 1
- 206010049933 Hypophosphatasia Diseases 0.000 claims 1
- 102000004195 Isomerases Human genes 0.000 claims 1
- 108090000769 Isomerases Proteins 0.000 claims 1
- 208000001182 Kniest dysplasia Diseases 0.000 claims 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
- 206010024503 Limb reduction defect Diseases 0.000 claims 1
- 101710175625 Maltose/maltodextrin-binding periplasmic protein Proteins 0.000 claims 1
- 208000037153 Mesomelic dysplasia, Nievergelt type Diseases 0.000 claims 1
- 208000011262 Micromelia Diseases 0.000 claims 1
- 206010028095 Mucopolysaccharidosis IV Diseases 0.000 claims 1
- 208000029578 Muscle disease Diseases 0.000 claims 1
- 208000021642 Muscular disease Diseases 0.000 claims 1
- -1 ProTEV Proteins 0.000 claims 1
- 208000033626 Renal failure acute Diseases 0.000 claims 1
- 201000001718 Roberts syndrome Diseases 0.000 claims 1
- 208000020221 Short stature Diseases 0.000 claims 1
- 206010072610 Skeletal dysplasia Diseases 0.000 claims 1
- 102100036407 Thioredoxin Human genes 0.000 claims 1
- 108091023040 Transcription factor Proteins 0.000 claims 1
- 102000040945 Transcription factor Human genes 0.000 claims 1
- 239000008351 acetate buffer Substances 0.000 claims 1
- 208000005065 achondrogenesis Diseases 0.000 claims 1
- 201000007047 acrodysostosis Diseases 0.000 claims 1
- 208000001884 acromesomelic dysplasia Diseases 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 201000011040 acute kidney failure Diseases 0.000 claims 1
- 208000012998 acute renal failure Diseases 0.000 claims 1
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 230000003078 antioxidant effect Effects 0.000 claims 1
- 235000006708 antioxidants Nutrition 0.000 claims 1
- 208000011775 arteriosclerosis disease Diseases 0.000 claims 1
- 235000010323 ascorbic acid Nutrition 0.000 claims 1
- 229960005070 ascorbic acid Drugs 0.000 claims 1
- 239000011668 ascorbic acid Substances 0.000 claims 1
- 201000007845 atelosteogenesis Diseases 0.000 claims 1
- 230000001580 bacterial effect Effects 0.000 claims 1
- 108010005774 beta-Galactosidase Proteins 0.000 claims 1
- 210000000988 bone and bone Anatomy 0.000 claims 1
- 239000004067 bulking agent Substances 0.000 claims 1
- 208000020832 chronic kidney disease Diseases 0.000 claims 1
- 208000022831 chronic renal failure syndrome Diseases 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 201000007394 diastrophic dysplasia Diseases 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 208000003350 fibrochondrogenesis Diseases 0.000 claims 1
- 239000001963 growth medium Substances 0.000 claims 1
- 230000002440 hepatic effect Effects 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 208000011111 hypophosphatemic rickets Diseases 0.000 claims 1
- 210000003000 inclusion body Anatomy 0.000 claims 1
- 238000002955 isolation Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 208000011426 mesomelic dysplasia Diseases 0.000 claims 1
- 201000010828 metaphyseal dysplasia Diseases 0.000 claims 1
- 229930182817 methionine Natural products 0.000 claims 1
- 229960004452 methionine Drugs 0.000 claims 1
- 235000006109 methionine Nutrition 0.000 claims 1
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 claims 1
- 208000010978 mucopolysaccharidosis type 4 Diseases 0.000 claims 1
- 210000002464 muscle smooth vascular Anatomy 0.000 claims 1
- 201000008482 osteoarthritis Diseases 0.000 claims 1
- 230000009984 peri-natal effect Effects 0.000 claims 1
- 208000027612 peripheral dysostosis Diseases 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 208000003580 polydactyly Diseases 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 208000037803 restenosis Diseases 0.000 claims 1
- 201000010809 spondyloepimetaphyseal dysplasia Diseases 0.000 claims 1
- 201000003504 spondyloepiphyseal dysplasia congenita Diseases 0.000 claims 1
- 201000003896 thanatophoric dysplasia Diseases 0.000 claims 1
- 229940035024 thioglycerol Drugs 0.000 claims 1
- 108060008226 thioredoxin Proteins 0.000 claims 1
- 229940094937 thioredoxin Drugs 0.000 claims 1
Classifications
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- 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
- C07K14/575—Hormones
- C07K14/58—Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Cardionatrin; Cardiodilatin
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
-
- A—HUMAN NECESSITIES
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- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/2242—Atrial natriuretic factor complex: Atriopeptins, atrial natriuretic protein [ANP]; Cardionatrin, Cardiodilatin
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P7/10—Antioedematous agents; Diuretics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- A—HUMAN NECESSITIES
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- 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
- C12N15/70—Vectors or expression systems specially adapted for E. coli
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/58—Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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- G—PHYSICS
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- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/10—Musculoskeletal or connective tissue disorders
- G01N2800/105—Osteoarthritis, e.g. cartilage alteration, hypertrophy of bone
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- G01N2800/00—Detection or diagnosis of diseases
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- G01—MEASURING; TESTING
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- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
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- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Cardiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Endocrinology (AREA)
- Physical Education & Sports Medicine (AREA)
- Biochemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Immunology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Toxicology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Urology & Nephrology (AREA)
- Neurology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Vascular Medicine (AREA)
- Rheumatology (AREA)
- Hospice & Palliative Care (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (15)
1. Varijanta natriuretičnog peptida C-tipa (CNP) naznačena time što je odabrana iz skupine koju čine:
LQEHPNARKYKGANKKGLSKGCFGLKLDRIGSMSGLGC (CNP-38) (SEQ ID NO: 160); i
HPNARKYKGANKKGLSKGCFGLKLDRIGSMSGLGC (CNP-35) (SEQ ID NO: 162).
2. Varijanta CNP prema patentnom zahtjevu 1, naznačena time što varijanta CNP je LQEHPNARKYKGANKKGLSKGCFGLKLDRIGSMSGLGC (CNP-38) (SEQ ID NO: 160).
3. Varijanta CNP prema patentnom zahtjevu 1 ili 2, naznačena time što nadalje sadrži hidrofilni polimer.
4. Varijanta CNP prema patentnom zahtjevu 3, naznačena time što je hidrofilni polimer polietilen glikol (PEG).
5. Varijanta CNP prema patentnom zahtjevu 3 ili zahtjevu 4, naznačena time što je hidrofilni polimer konjugiran s varijantom CNP na mjestu odabranom iz skupine koju čine (1) samo na N-kraju; (2) samo na C-kraju; (3) samo na unutarnjem mjestu; (4) na oba N-kraja i C-kraju; (5) na N-kraju i unutarnjem mjestu; i (6) na C-kraju i unutarnjem mjestu.
6. Varijanta CNP prema patentnom zahtjevu 5, naznačena time što je hidrofilni polimer konjugiran s varijantom CNP na unutarnjem mjestu, pri čemu je navedeno unutarnje mjesto aminokiselinski položaj Lys-20 u SEQ.ID.No:160 ili aminokiselinski položaj Lys-17 u SEQ.ID.No:162.
7. Varijanta CNP prema bilo kojem od patentnih zahtjeva 3-6, naznačena time što nadalje sadrži vezu koja se može hidrolizirati koja konjugira hidrofilni polimer u varijantu CNP.
8. Farmaceutski pripravak koji sadrži varijantu CNP prema bilo kojem od prethodnih patentnih zahtjeva, i farmaceutski prihvatljivu pomoćnu tvar, nosač, ili razrjeđivač.
9. Farmaceutski pripravak prema patentnom zahtjevu 8, naznačen time što je liofilizirani pripravak pripravljen iz formulacije koja sadrži pufer limunska kiselina/citrat ili octena pufer kiselina/acetat koji ima pH od 4 do 6, pri čemu formulacija proizvoljno dodatno sadrži sredstvo za podešavanje izotoničnosti i/ili sredstvo za povećavanje volumena, i/ili nadalje sadrži antioksidans koji je odabran iz skupine koju čine metionin, askorbinska kiselina, oblici soli askorbinske kiseline, tioglicerol, i njihove kombinacije.
10. Varijanta CNP prema bilo kojem od patentnih zahtjeva 1-7 ili farmaceutski pripravak prema zahtjevu 8 ili zahtjevu 9 naznačen time što je za uporabu u postupku za liječenje poremećaja povezanog s kostima ili skeletne displazije koji su odabrani iz skupine koja se sastoji od osteoartritisa, hipofosfatemijskog rahitisa, ahondroplazije, hipohondroplazije, niskog rasta, patuljastog rasta, osteohondroplazija, tanatoforne displazije, osteogenesis imperfecta, ahondrogeneze, homozigotne ahondroplazije, hondrodisplazije punktata, kamptomelijske displazije, kongenitalne smrtonosne hipofosfatazije, perinatalnog smrtonosnog tipa osteogenesis imperfecta, sindroma polidaktilije s kratkim rebrima, hipohondroplazije, rizomelijskog tipa hondrodisplazije punktata, Jansenovog tipa metafizalne displazije, spondiloepifizealne displazije kongenita, atelosteogeneze, dijastrofične displazije, kongenitalnog kratkog femura, Langerovog tipa mezomelične displazije, Nievergeltovog tipa mezomelične displazije, Robinowog sindroma, Reinhardtovog sindroma, akrodisostoze, periferne disostoze, Kniestove displazije, fibrohondrogeneze, Robertsovog sindroma, akromezomelične displazije, mikromelije, Morquio sindroma, Kniestovog sindroma, metatrofične displazije, te spondiloepimetafizealne displazije.
11. Varijanta CNP prema bilo kojem od patentnih zahtjeva 1-7 ili farmaceutski pripravak prema zahtjevu 8 ili zahtjevu 9 naznačen time što je za uporabu u postupku liječenja vaskularnog poremećaja glatkih mišića koji je odabran iz skupine koju čine hipertenzija, restenoza, arterioskleroza, akutno dekompenzacijsko zatajenje srca, kongestivno zatajenje srca, srčani edem, bubrežni edem, jetreni edem, akutna insuficijencija bubrega, te kronična insuficijencija bubrega.
12. Postupak za rekombinantnu proizvodnju varijante CNP prema bilo kojem od patentnih zahtjeva 1-7, naznačen time što sadrži:
(i) kultiviranje bakterijske stanice domaćina koja sadrži prvi polinukleotid koji kodira CNP varijantu polipeptida prema zahtjevu 1 vezan na drugi polinukleotid koji kodira cijepajući peptid ili bjelančevina pod uvjetima koji rezultiraju ekspresijom fuzijskog polipeptida koji je kodiran s navedenim prvim i drugim polinukleotidima, pri čemu fuzijski polipeptid sadrži navedenu CNP varijantu izravno vezanu na navedeni cijepajući peptid ili bjelančevina ili neizravno vezanu na njih preko poveznice i pri čemu je cijepajući peptid ili bjelančevina odabran iz skupine koju čine histidinske oznake, ljudski transkripcijski faktor r TAF12, TAF12 histonsku višekratnu domenu, TAF12(C/A), TAF12(D/E), TAF12(6D/6E), TAF12(10D/10E), TAF12(C/A & D/E), TAF12(C/A & 4D/4E), TAF12(C/A & 6D/6E), TAF12(C/A & 10D/10E), ketosteroidna izomeraza, bjelančevina koja veže maltozu, ß-galaktozidaza, glutation-S-transferaza, tioredoksin, domena koja veže hitin, BMP-2, i BMP-2(C/A), i
(ii) cijepanje navedenog cijepajućeg peptida ili bjelančevina iz navedenog fuzijskog polipeptida radi oslobađanja navedene varijante CNP.
13. Postupak prema patentnom zahtjevu 12, naznačen time što je fuzijski polipeptid eksprimiran kao topivi protein ili kao inkluzijsko tijelo, te dodatno sadrži izoliranje eksprimiranog fuzijskog polipeptida iz stanice domaćina ili medija za kultiviranje.
14. Postupak prema patentnom zahtjevu 12 ili 13, naznačen time što nadalje sadrži dovođenje u kontakt izoliranog fuzijskog polipeptida sa sredstvom za cijepanje koje se bira iz skupine koju čine mravlja kiselina, cijanogen bromid (CNBr), hidroksilamin, samo cijepajući protein, Faktor Xa, enterokinaza, ProTEV, i SUMO proteaza.
15. Postupak prema patentnom zahtjevu 14, naznačen time što je sredstvo za cijepanje mravlja kiselina, te pri čemu se dovođenje u kontakt izoliranog fuzijskog polipeptida sa sredstvom za cijepanje provodi u prisutnosti od 1% do 10% mravlje kiseline kod temperature od 50 °C do 70 °C u vremenskom periodu od 5 sati do 36 sati.
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