ME02062B - Primena lizozomalne kisele lipaze za lecenje nedostatka lizozomalne kisele lipaze kod pacijenata - Google Patents
Primena lizozomalne kisele lipaze za lecenje nedostatka lizozomalne kisele lipaze kod pacijenataInfo
- Publication number
- ME02062B ME02062B MEP-2015-41A MEP4115A ME02062B ME 02062 B ME02062 B ME 02062B ME P4115 A MEP4115 A ME P4115A ME 02062 B ME02062 B ME 02062B
- Authority
- ME
- Montenegro
- Prior art keywords
- recombinant human
- lal
- use according
- human lal
- sufficient
- Prior art date
Links
Classifications
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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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
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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
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
- C12N9/18—Carboxylic ester hydrolases (3.1.1)
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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
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
- C12N9/18—Carboxylic ester hydrolases (3.1.1)
- C12N9/20—Triglyceride splitting, e.g. by means of lipase
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y301/00—Hydrolases acting on ester bonds (3.1)
- C12Y301/01—Carboxylic ester hydrolases (3.1.1)
- C12Y301/01013—Sterol esterase (3.1.1.13)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Wood Science & Technology (AREA)
- Genetics & Genomics (AREA)
- Zoology (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Gastroenterology & Hepatology (AREA)
- Biotechnology (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Diabetes (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Enzymes And Modification Thereof (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Claims (33)
1.Rekombinantna humana lizozomalna kisela lipaze (Lysosomal acid lipase) (LAL) za primenu u lečenju ljudskog pacijenta koji pati od nedostatka LAL primenom na ljudskog pacijenta, pri čemu je primena dovoljna da normalizuje serumske nivoe transaminaze iz jetre navedenog ljudskog pacijenta i da smanji oštećenje jetre kod navedenog ljudskog pacijenta, i pri čemu rekombinanatna humana LAL je za primenu na ljudskog pacijenta između jednog puta svakih 7 dana i jednog puta svakih 30 dana.
2.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena transaminaza jetre je odabrana iz grupe koja se sastoji od seruma aspartata transaminaze (AST) i alanin transaminaze (ALT).
3.Rekombinantna humana LAL za primenu prema zahtevu 2, pri čemu navedena transaminaza jetre je AST.
4.Rekombinantna humana LAL za primenu prema zahtevu 2, pri čemu navedena transaminaza jetre je ALT.
5. Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da se minimizira hepatomegalija.
6. Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da poveća serumske nivoe hemoglobina.
7. Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da smanji veličinu jetre.
8.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da smanji serumske nivoe feritina.
9.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena rekombinanatna humana LAL se primenjuje jedan put svakih 7 dana.
10.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena rekombinantna humana LAL se primenjuje jedan put svakih 14 dana.
11.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedeni ljudski pacijent pati od Wolmanove bolesti.
12.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedeni ljudski pacijent pati od obolenja skladištenja holesteril estra.
13.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu rekombinantna humana LAL obuhvata bar jednu manozu ili manoza-6-fosfat.
14.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena količina rekombinantne humane LAL dovoljna da normalizuje serumske nivoe transaminaze jetre je oko 1 mg po kilogramu telesne težine navedenog ljudskog pacijenta.
15.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da se postigne LAL polu-vek (t1/2) koji je manji od 20 minuta.
16.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da se postigne LAL polu-vek (t1/2) od oko 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 ili 17 minuta.
17.Rekombinanatna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da se postigne Cmax od 200 ng/mL do 1500 ng/mL.
18.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da se postigne Cmax od 200 ng/mL do 800 ng/mL.
19.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena rekombinantna humana LAL se primenjuje intravenozno.
20.Rekombinanatna humana LAL za primenu prema zahtevu 19, pri čemu navedena primena je infuzijom.
21.Rekombinantna humana LAL za primenu prema zahtevu 20, pri čemu infuzija je za jedan do četiri sata.
22. Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedena primena je dovoljna da smanji limfadenopatiju.
23.Rekombinantna humana LAL za primenu prema zahtevu 1, pri čemu navedeni ljudski pacijent je manji od 1 godine starosti i navedena primena je dovoljna da se poveća brzina rasta navedenog ljudskog pacijenta.
24.Rekombinantna humana LAL za primenu prema zahtevu 1, dalje obuhvata primenu drugog leka.
25.Rekombinantna humana LAL za primenu prema zahtevu 24, pri čemu drugi lek je lek koji smanjuje holesterol.
26.Rekombinantna humana LAL za primenu prema zahtevu 25, pri čemu navedeni lek za smanjenje holesterola je statin.
27.Rekombinanatna humana LAL za primenu prema zahtevu 25, pri čemu navedeni lek koji smanjuje holesterol je ezetimib.
28. Rekombinantna humana LAL za primenu prema zahtevu 24, pri čemu drugi lek je imunosupresant.
29.Rekombinantna humana LAL za primenu prema zahtevu 24, pri čemu navedeni drugi lek je antihistamin.
30.Rekombinantna humana LAL za primenu prema zahtevu 29, pri čemu navedeni antihistamin je difenhidramin.
31.Rekombinanatna humana LAL za primenu prema zahtevu 29 ili 30, pri čemu antihistamin se primenjuje u dozi od 1 mg do 5 mg po kilogramu telesne težine navedenog ljudskog pacijenta.
32.Rekombinantna humana LAL za primenu prema zahtevu 29 ili 30, pri čemu antihistamin se primenjuje između 20 i 90 minuta pre primene rekombinantne humane LAL.
33.Primena rekombinantne humane lizozomalne kisele lipaze (Lysosomal acid lipase) (LAL) u proizvodnji medikamenta za lečenje ljudskog pacijenta koji pati od nedostatka LAL normalizovanjem serumskih nivoa transaminaze jetre navedenog ljudskog pacijenta i smanjenjem oštećenja jetre kod navedenog ljudskog pacijenta između jednog puta svakih 7 dana i jednog puta svakih 30 dana kao što je definisano u bilo kom od zahteva 1 do 32.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US40301110P | 2010-09-09 | 2010-09-09 | |
| US45601410P | 2010-10-29 | 2010-10-29 | |
| US201161432372P | 2011-01-13 | 2011-01-13 | |
| PCT/US2011/033699 WO2011133960A2 (en) | 2010-04-23 | 2011-04-23 | Lysosomal storage disease enzyme |
| PCT/US2011/051096 WO2012050695A1 (en) | 2010-09-09 | 2011-09-09 | Use of lysosomal acid lipase for treating lysosomal acid lipase deficiency in patients |
| EP11758644.6A EP2613798B2 (en) | 2010-09-09 | 2011-09-09 | Use of lysosomal acid lipase for treating lysosomal acid lipase deficiency in patients |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME02062B true ME02062B (me) | 2015-05-20 |
Family
ID=45806910
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2015-41A ME02062B (me) | 2010-09-09 | 2011-09-09 | Primena lizozomalne kisele lipaze za lecenje nedostatka lizozomalne kisele lipaze kod pacijenata |
Country Status (30)
| Country | Link |
|---|---|
| US (6) | US8663631B2 (me) |
| EP (3) | EP2613798B2 (me) |
| JP (3) | JP5693728B2 (me) |
| KR (1) | KR20150038636A (me) |
| CN (2) | CN105457018A (me) |
| AR (1) | AR082953A1 (me) |
| AU (1) | AU2011314293B2 (me) |
| BR (2) | BR112013005673B1 (me) |
| CA (2) | CA2810999C (me) |
| CL (1) | CL2013000664A1 (me) |
| CO (1) | CO6710913A2 (me) |
| CY (1) | CY1116544T1 (me) |
| DK (2) | DK2977057T3 (me) |
| ES (2) | ES2535605T5 (me) |
| HK (2) | HK1220907A1 (me) |
| HR (1) | HRP20150438T1 (me) |
| HU (1) | HUE048688T2 (me) |
| IL (2) | IL225095A (me) |
| ME (1) | ME02062B (me) |
| MX (2) | MX2013002704A (me) |
| NZ (3) | NZ700824A (me) |
| PL (2) | PL2613798T5 (me) |
| PT (2) | PT2977057T (me) |
| RS (1) | RS53947B1 (me) |
| RU (1) | RU2550961C2 (me) |
| SG (2) | SG188456A1 (me) |
| SI (2) | SI2977057T1 (me) |
| SM (1) | SMT201500108B (me) |
| TW (1) | TWI482625B (me) |
| WO (1) | WO2012050695A1 (me) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP1267914B2 (en) * | 2000-02-04 | 2013-11-06 | Children's Hospital Research Foundation | Use of lysosomal acid lipase for treating atherosclerosis and related diseases |
| WO2007030375A2 (en) * | 2005-09-08 | 2007-03-15 | Children's Hospital Medical Center | Lysosomal acid lipase therapy for nafld and related diseases |
| AU2011242461B2 (en) | 2010-04-23 | 2015-10-01 | Alexion Pharmaceuticals, Inc. | Lysosomal storage disease enzyme |
| AR082953A1 (es) | 2010-09-09 | 2013-01-23 | Synageva Biopharma Corp | Metodos para tratar deficiencia de acido lisosomal lipasa en pacientes |
| KR20140006037A (ko) | 2011-02-15 | 2014-01-15 | 시나게바 바이오파르마, 코포레이션 | 리소좀의 산 리파제 결핍을 치료하는 방법들 |
| RU2014117291A (ru) | 2011-10-12 | 2015-11-20 | Синаджева Биофарма Корп. | Рекомбинантный человеческий белок naglu и его применение |
| US20150098933A1 (en) * | 2012-03-02 | 2015-04-09 | Synageva Biopharma Corp. | Truncated lysosomal acid lipase |
| CN106885910B (zh) * | 2015-12-15 | 2018-12-21 | 上海吉涛生物科技有限公司 | 肿瘤易感微环境检测装置及试剂盒 |
| EP3472352A1 (en) | 2016-06-17 | 2019-04-24 | Alexion Pharmaceuticals, Inc. | Lysosomal acid lipase deficiency compositions and methods |
| US11155794B2 (en) | 2016-08-23 | 2021-10-26 | Alexion Pharmaceuticals, Inc. | Method of purifying a heterologous protein from an egg white |
| US10633705B2 (en) | 2016-10-14 | 2020-04-28 | Alexion Pharmaceuticals, Inc. | N-acetyl-alpha-D-glucosaminidase deficiency compositions and methods |
| US10738338B2 (en) | 2016-10-18 | 2020-08-11 | The Research Foundation for the State University | Method and composition for biocatalytic protein-oligonucleotide conjugation and protein-oligonucleotide conjugate |
| US11396499B2 (en) | 2018-12-12 | 2022-07-26 | University Of Washington | Lysosomal acid lipase assay |
| WO2021117122A1 (ja) * | 2019-12-10 | 2021-06-17 | 株式会社リボルナバイオサイエンス | ライソゾーム酸性リパーゼ欠損症の予防または治療剤 |
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