RU2006128293A - Коньюгаты гормона роста человека, монопэгилированного по n-концу, способ их получения и способы их применения - Google Patents
Коньюгаты гормона роста человека, монопэгилированного по n-концу, способ их получения и способы их применения Download PDFInfo
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- RU2006128293A RU2006128293A RU2006128293/14A RU2006128293A RU2006128293A RU 2006128293 A RU2006128293 A RU 2006128293A RU 2006128293/14 A RU2006128293/14 A RU 2006128293/14A RU 2006128293 A RU2006128293 A RU 2006128293A RU 2006128293 A RU2006128293 A RU 2006128293A
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- Prior art keywords
- growth hormone
- formula
- polyethylene glycol
- hgh
- human growth
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- 238000000034 method Methods 0.000 title claims abstract 10
- 108010000521 Human Growth Hormone Proteins 0.000 title claims abstract 9
- 102000002265 Human Growth Hormone Human genes 0.000 title claims abstract 9
- 239000000854 Human Growth Hormone Substances 0.000 title claims abstract 9
- 238000004519 manufacturing process Methods 0.000 title 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract 7
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract 7
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract 6
- 208000035475 disorder Diseases 0.000 claims abstract 4
- 108010051696 Growth Hormone Proteins 0.000 claims abstract 3
- 102000018997 Growth Hormone Human genes 0.000 claims abstract 3
- 239000000122 growth hormone Substances 0.000 claims abstract 3
- COLNVLDHVKWLRT-UHFFFAOYSA-N phenylalanine Natural products OC(=O)C(N)CC1=CC=CC=C1 COLNVLDHVKWLRT-UHFFFAOYSA-N 0.000 claims abstract 3
- 230000009286 beneficial effect Effects 0.000 claims abstract 2
- COLNVLDHVKWLRT-QMMMGPOBSA-N phenylalanine group Chemical group N[C@@H](CC1=CC=CC=C1)C(=O)O COLNVLDHVKWLRT-QMMMGPOBSA-N 0.000 claims abstract 2
- 206010056438 Growth hormone deficiency Diseases 0.000 claims 4
- 206010053759 Growth retardation Diseases 0.000 claims 4
- 201000010769 Prader-Willi syndrome Diseases 0.000 claims 3
- 208000020832 chronic kidney disease Diseases 0.000 claims 3
- 208000022831 chronic renal failure syndrome Diseases 0.000 claims 3
- 201000010099 disease Diseases 0.000 claims 3
- 208000026928 Turner syndrome Diseases 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 108700031632 somatrem Proteins 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- 206010029748 Noonan syndrome Diseases 0.000 claims 1
- 206010036590 Premature baby Diseases 0.000 claims 1
- 208000020221 Short stature Diseases 0.000 claims 1
- 208000032851 Subarachnoid Hemorrhage Diseases 0.000 claims 1
- 208000030886 Traumatic Brain injury Diseases 0.000 claims 1
- 230000001133 acceleration Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000003862 glucocorticoid Substances 0.000 claims 1
- 231100000001 growth retardation Toxicity 0.000 claims 1
- 208000018773 low birth weight Diseases 0.000 claims 1
- 231100000533 low birth weight Toxicity 0.000 claims 1
- 230000009529 traumatic brain injury Effects 0.000 claims 1
- ZTQSAGDEMFDKMZ-UHFFFAOYSA-N Butyraldehyde Chemical group CCCC=O ZTQSAGDEMFDKMZ-UHFFFAOYSA-N 0.000 abstract 1
- 230000006806 disease prevention Effects 0.000 abstract 1
- 230000000694 effects Effects 0.000 abstract 1
- 230000002045 lasting effect Effects 0.000 abstract 1
- 102000035118 modified proteins Human genes 0.000 abstract 1
- 108091005573 modified proteins Proteins 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- 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
- A61K38/27—Growth hormone [GH], i.e. somatotropin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- A61K47/50—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
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—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
- A61K47/50—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
- 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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- A—HUMAN NECESSITIES
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs 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
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A61P19/00—Drugs for skeletal disorders
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- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
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- A61P25/00—Drugs for disorders of the nervous system
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- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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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
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
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- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
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- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
- A61P5/46—Drugs for disorders of the endocrine system of the suprarenal hormones for decreasing, blocking or antagonising the activity of glucocorticosteroids
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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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
-
- 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
- C07K14/61—Growth hormone [GH], i.e. somatotropin
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Epidemiology (AREA)
- Neurology (AREA)
- Physical Education & Sports Medicine (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Toxicology (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Immunology (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
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- Hematology (AREA)
- Reproductive Health (AREA)
- Urology & Nephrology (AREA)
- Gynecology & Obstetrics (AREA)
Claims (10)
1. Способ предотвращения и/или лечения заболевания или расстройства, при котором полезно применение гормона роста, включающий введение пациенту, нуждающемуся в этом, терапевтически эффективного количества модифицированного полиэтиленгликолем ГРЧ, который имеет структуру формулы I или II
Формула I
или
Формула II
где n является целым числом от 1 до 10;
m является целым числом от 1 до 10;
R является гормоном роста человека или метионил-гормоном роста,
одного или в комбинации с другим терапевтическим средством, где указанное заболевание или расстройство, при котором полезно применение гормона роста, выбрано из группы, состоящей из недостаточности гормона роста (GHD), недостаточности гормона роста у взрослых (aGHD), синдрома Тернера; задержки роста у детей, чей рост при рождении был недостаточным для гестационного возраста (SGA); синдрома Прадера-Вилли (PWS), хронической почечной недостаточности (CRI), травматического повреждения головного мозга, субарахноидального кровоизлияния, синдрома Нунан, идиопатической низкорослости (ISS), очень низкой массы при рождении (VLBW), низкорослости у детей вследствия лечения глюкокортикоидами и отсутствия ускорения роста у низкорослых недоношенных детей.
2. Способ по п.1, где указанное заболевание или расстройство, в котором полезно применение ГР, выбрано из группы, состоящей из GHD, aGHD, синдрома Тернера, SGA, PWS, CRI и ISS.
3. Способ по п.1 или 2, где n равно 4, а m равно 3.
4. Способ по п.3, где указанный модифицированный полиэтиленгликолем ГРЧ имеет структуру формулы I, причем n равно 4 и m равно 3.
5. Способ по п.1, где указанный гормон роста человека включает аминокислотную последовательность SEQ ID NO:1.
6. Способ по п.5, где более 90% указанного полиэтиленгликоля конъюгировано с N-концевым фенилаланином аминокислотной последовательности SEQ ID NO:1.
7. Способ по 6, где более 95% указанного полиэтиленгликоля конъюгировано с N-концевым фенилаланином аминокислотной последовательности SEQ ID NO:1.
8. Способ по п.1, где каждый мПЭГ имеет молекулярную массу приблизительно 20 кДа.
9. Композиция, содержащая конъюгат гормона роста человека с с ПЭГ формулы I или II в комбинации с другим терапевтическим средством и по меньшей мере с одним фармацевтически приемлемым носителем
Формула I
или
Формула II
где n является целым числом от 1 до 10;
m является целым числом от 1 до 10;
R является гормоном роста человека или метионил-гормоном роста.
10. Композиция по п.9, где указанный модифицированный полиэтиленгликолем ГРЧ имеет структуру формулы I, причем n равно 4 и m равно 3.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/771,895 | 2004-02-04 | ||
US10/771,895 US20040142870A1 (en) | 2002-11-20 | 2004-02-04 | N-terminally monopegylated human growth hormone conjugates, process for their preparation, and methods of use thereof |
Publications (1)
Publication Number | Publication Date |
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RU2006128293A true RU2006128293A (ru) | 2008-02-10 |
Family
ID=34886516
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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RU2006128293/14A RU2006128293A (ru) | 2004-02-04 | 2005-01-24 | Коньюгаты гормона роста человека, монопэгилированного по n-концу, способ их получения и способы их применения |
Country Status (21)
Country | Link |
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US (1) | US20040142870A1 (ru) |
EP (2) | EP1715887B1 (ru) |
JP (3) | JP2007520544A (ru) |
KR (2) | KR100776862B1 (ru) |
CN (1) | CN1929857A (ru) |
AT (1) | ATE365047T1 (ru) |
AU (1) | AU2005215250A1 (ru) |
BR (1) | BRPI0507427A (ru) |
CA (1) | CA2555772A1 (ru) |
CY (1) | CY1106723T1 (ru) |
DE (1) | DE602005001445T2 (ru) |
DK (1) | DK1715887T3 (ru) |
ES (1) | ES2286787T3 (ru) |
IL (1) | IL176998A0 (ru) |
NO (1) | NO20063926L (ru) |
PL (1) | PL1715887T3 (ru) |
PT (1) | PT1715887E (ru) |
RU (1) | RU2006128293A (ru) |
TW (2) | TW200529868A (ru) |
WO (1) | WO2005079838A1 (ru) |
ZA (2) | ZA200706349B (ru) |
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US20040142870A1 (en) * | 2002-11-20 | 2004-07-22 | Finn Rory F. | N-terminally monopegylated human growth hormone conjugates, process for their preparation, and methods of use thereof |
PL396711A1 (pl) * | 2002-12-26 | 2011-12-19 | Mountain View Pharmaceuticals, Inc. | Koniugaty polimerów z cytokinami, chemokinami, czynnikami wzrostu, hormonami polipeptydowymi i ich antagonistami, kompozycja farmaceutyczna i sposób zapobiegania, diagnozowania lub leczenia |
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EP2113256A1 (en) | 2008-04-29 | 2009-11-04 | Ascendis Pharma AS | PEGylated rhGH compounds |
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WO2011018515A1 (en) * | 2009-08-14 | 2011-02-17 | Novo Nordisk Health Care Ag | Method of purifying pegylated proteins |
WO2011073234A2 (en) | 2009-12-15 | 2011-06-23 | Ascendis Pharma As | Growth hormone composition |
CN102453089B (zh) * | 2010-10-25 | 2014-06-04 | 北京凯因科技股份有限公司 | 重组集成干扰素变异体聚乙二醇偶联物的制备和应用 |
EP2788014B8 (en) * | 2011-12-09 | 2019-10-23 | Metabolic Pharmaceuticals Pty Ltd | Use of growth hormone fragments |
CN102964588A (zh) * | 2012-11-09 | 2013-03-13 | 河南工业大学 | 末端连接氨基苯丙酸的聚乙二醇的酸或活性酯的制法和应用 |
KR101599415B1 (ko) | 2015-05-29 | 2016-03-03 | (주)신명이앤씨 | 건축물 층간 바닥 전기 케이블 보호관 |
CN114539384A (zh) * | 2020-11-19 | 2022-05-27 | 江苏众红生物工程创药研究院有限公司 | 聚乙二醇化长效生长激素及其制备方法和医药应用 |
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RS53104A (en) * | 2001-11-20 | 2006-10-27 | Pharmacia Corporation | Chemically-modified human growth hormone conjugates |
US20040142870A1 (en) * | 2002-11-20 | 2004-07-22 | Finn Rory F. | N-terminally monopegylated human growth hormone conjugates, process for their preparation, and methods of use thereof |
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- 2005-01-24 AU AU2005215250A patent/AU2005215250A1/en not_active Abandoned
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BRPI0507427A (pt) | 2007-06-26 |
TW200529868A (en) | 2005-09-16 |
KR20060120240A (ko) | 2006-11-24 |
CA2555772A1 (en) | 2005-09-01 |
JP2008037872A (ja) | 2008-02-21 |
US20040142870A1 (en) | 2004-07-22 |
NO20063926L (no) | 2006-10-30 |
DE602005001445D1 (de) | 2007-08-02 |
ATE365047T1 (de) | 2007-07-15 |
JP2008001713A (ja) | 2008-01-10 |
AU2005215250A1 (en) | 2005-09-01 |
KR100776862B1 (ko) | 2007-11-28 |
PT1715887E (pt) | 2007-08-29 |
TW200812610A (en) | 2008-03-16 |
CN1929857A (zh) | 2007-03-14 |
CY1106723T1 (el) | 2012-05-23 |
ZA200606375B (en) | 2007-11-28 |
PL1715887T3 (pl) | 2007-12-31 |
DE602005001445T2 (de) | 2008-02-14 |
KR20070039623A (ko) | 2007-04-12 |
DK1715887T3 (da) | 2007-09-17 |
WO2005079838A1 (en) | 2005-09-01 |
ES2286787T3 (es) | 2007-12-01 |
JP2007520544A (ja) | 2007-07-26 |
EP1715887B1 (en) | 2007-06-20 |
EP1715887A1 (en) | 2006-11-02 |
IL176998A0 (en) | 2006-12-10 |
ZA200706349B (en) | 2008-06-25 |
EP1915999A1 (en) | 2008-04-30 |
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