ES2601892T3 - Pentapolímero aleatorio para el tratamiento de enfermedades autoinmunes - Google Patents

Pentapolímero aleatorio para el tratamiento de enfermedades autoinmunes Download PDF

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Publication number
ES2601892T3
ES2601892T3 ES12774372.2T ES12774372T ES2601892T3 ES 2601892 T3 ES2601892 T3 ES 2601892T3 ES 12774372 T ES12774372 T ES 12774372T ES 2601892 T3 ES2601892 T3 ES 2601892T3
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Prior art keywords
pentapolymer
treatment
random
autoimmune diseases
vehicle
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ES12774372.2T
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English (en)
Inventor
Ehud Marom
Shai Rubnov
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Mapi Pharma Ltd
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Mapi Pharma Ltd
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    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G69/00—Macromolecular compounds obtained by reactions forming a carboxylic amide link in the main chain of the macromolecule
    • C08G69/02—Polyamides derived from amino-carboxylic acids or from polyamines and polycarboxylic acids
    • C08G69/08—Polyamides derived from amino-carboxylic acids or from polyamines and polycarboxylic acids derived from amino-carboxylic acids
    • C08G69/10—Alpha-amino-carboxylic acids
    • 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
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/001—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof by chemical synthesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Polymers & Plastics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

Un pentapolímero o una sal del mismo, que es un copolímero lineal de alanina, ácido glutámico, lisina, tirosina y fenilalanina.

Description

imagen1
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suspensión blanca homogénea, capaz de ser extraída e inyectada a través de una aguja adecuada.
Formación de vehículos:
5 Vehículo 1: solución salina, 0,9% de NaCL en agua estéril Vehículo 2: agua para inyección (WFI)
Reactivos:
MOG 35-55: (GL BiochemCo. Ltd; Shanghái, P.R. China). MOG 35-55. El MOG 35-55 se disuelve en solución salina a una concentración de 2 mg/ml.
Adyuvante Completo de Freund (CFA) (Cat: F5881; Sigma-Aldrich; St. Louis, MO, USA).Se añade la cepa Mycobacterium tuberculosis H37RA matada por calor (Cat: 231141; Difco; Detroit, MI, USA) al adyuvante completo 15 de Freund a una concentración final de 4 mg/ml.
Toxina de Bordetella pertussis (PTX): (Cat: P7208; Sigma-Aldrich; St. Louis, MO, USA).
Usando un homogeneizador de alta velocidad, la solución MOG anterior se emulsifica con volumen igual del CFA modificado en hielo para 30.000 rpm durante 1,5 horas.
Animales:
Ratones C57BL/6, hembra, 7 -9 semanas, 17 -20 g.
25 Adaptación: no menos de 7 días. Ambiente: ambiente Libre de Patógenos Específicos (SPF) Temperatura ambiente: 20 -26C Humedad relativa ambiente: 40 -70% Ciclo de luz: luz fluorescente durante 12 horas de luz (08:00 -20:00) y 12 horas de oscuridad. Alojamiento de animales: 3-4 ratones/caja por grupo de tratamiento Alimentación: acceso libre a comida (irradiada, Shanghai SLAC Laboratory Animal Co. Ltd., China). Agua: acceso libre a agua (agua del grifo filtrada por Mol Ultrapure Water System).
Asignación a grupos de tratamiento: 35 Los animales se asignaron a los grupos de tratamiento por aleatorización en software Biobook para lograr peso medio de grupo similar, que proporciona control del error sistemático.
Tabla 1 -Grupo y régimen de dosificación
45
55
Grupo Artículo de Prueba N Vía Conc. Dosificción Régimen Dosis en (días)
mg/ml ml/ratones mg/ratone s
1 PPb 10 s.c. 10 0.2 2 q.d. DO-9
2 GAb 10 i.m. 25 0.2 5 q.d. D0, 1, 14, 15, 28,29
3 GAb 10 i.m. 25 0.2 5 q.d. D0, 14, 28
4 GAb 10 i.m. 25 0.2 5 q.d. D0, 7, 14,21, 28
5 GA-depósitob 10 i.m. 312 0.2 62.5* q.d. D0, 1, 14, 15, 28,29
6 GA-depósitob 10 i.m. 312 0.2 62.5* q.d. D0, 14, 28
7 GA-depósitob 10 i.m. 312 0.2 62.5* q.d. D0, 7, 14,21, 28
8 GAb 10 s.c. 10 0.2 2 q.d. DO-9
9 Veha 10 s.c. N/A 0.2 N / q.d. DO-9
a: Vehículo en solución salina b: Vehículo es WFI * contenido de Ga es 80 mg/g de producto formulado "GA-depósito", es decir 5 mg/ratones/día de GA.
11
imagen10

Claims (1)

  1. imagen1
ES12774372.2T 2011-04-21 2012-04-16 Pentapolímero aleatorio para el tratamiento de enfermedades autoinmunes Active ES2601892T3 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161477610P 2011-04-21 2011-04-21
US201161477610P 2011-04-21
PCT/IL2012/050138 WO2012143924A1 (en) 2011-04-21 2012-04-16 Random pentapolymer for treatment of autoimmune diseases

Publications (1)

Publication Number Publication Date
ES2601892T3 true ES2601892T3 (es) 2017-02-16

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US (1) US9200114B2 (es)
EP (1) EP2699317B1 (es)
ES (1) ES2601892T3 (es)
WO (1) WO2012143924A1 (es)

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US12097292B2 (en) 2016-08-28 2024-09-24 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
WO2018042423A1 (en) 2016-08-28 2018-03-08 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
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IL316573A (en) 2017-03-26 2024-12-01 Mapi Pharma Ltd Storage systems containing glatiramer acetate for the treatment of multiple sclerosis
IL269893B2 (en) 2017-05-15 2023-10-01 Stem Cell Medicine Ltd Treatment of multiple sclerosis with adipose-derived stem cells
EP3624815A4 (en) 2017-05-15 2021-01-20 Stem Cell Medicine Ltd. TREATMENT OF MULTIPLE SCLEROSIS WITH LONG-ACTING GLATIRAMER AND ADAPTIVE STEM CELLS

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Also Published As

Publication number Publication date
US9200114B2 (en) 2015-12-01
WO2012143924A1 (en) 2012-10-26
EP2699317B1 (en) 2016-08-10
US20130156725A1 (en) 2013-06-20
EP2699317A1 (en) 2014-02-26
EP2699317A4 (en) 2014-12-03

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