AR087091A1 - Polipeptidos quimericos e hibridos del factor viii, y sus metodos de uso - Google Patents

Polipeptidos quimericos e hibridos del factor viii, y sus metodos de uso

Info

Publication number
AR087091A1
AR087091A1 ARP120102464A ARP120102464A AR087091A1 AR 087091 A1 AR087091 A1 AR 087091A1 AR P120102464 A ARP120102464 A AR P120102464A AR P120102464 A ARP120102464 A AR P120102464A AR 087091 A1 AR087091 A1 AR 087091A1
Authority
AR
Argentina
Prior art keywords
factor viii
subject
chain
administering
level
Prior art date
Application number
ARP120102464A
Other languages
English (en)
Original Assignee
Biogen Idec Hemophilia Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biogen Idec Hemophilia Inc filed Critical Biogen Idec Hemophilia Inc
Publication of AR087091A1 publication Critical patent/AR087091A1/es

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/56Medicinal 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
    • A61K47/59Medicinal 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
    • A61K47/60Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/31Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Urology & Nephrology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Food Science & Technology (AREA)
  • Toxicology (AREA)
  • General Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Analytical Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dermatology (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Reivindicación 1: Un método de administrar Factor VIII a un sujeto que lo necesita, que comprende administrar al sujeto una dosis terapéutica de un polipéptido quimérico que comprende una porción del Factor VIII y una segunda porción en un intervalo de dosis al menos aproximadamente una y medio veces más largo que el intervalo de dosis requerido para una dosis equivalente de un polipéptido que consiste en dicha porción del Factor VIII, donde dicha porción del Factor VIII comprende el Factor VIII procesado, que tiene dos cadenas, una primera cadena que comprende una cadena pesada y una segunda cadena que comprende una cadena liviana, donde dicha primera cadena y dicha segunda cadena se asocian con un enlace metálico. Reivindicación 39: Una composición que comprende un polipéptido quimérico que tiene actividad de Factor VIII, donde al menos aproximadamente 30%, aproximadamente 40%, aproximadamente 50%, aproximadamente 60%, aproximadamente 70%, aproximadamente 80%, aproximadamente 90%, aproximadamente 95%, aproximadamente 96%, aproximadamente 97%, aproximadamente 98%, aproximadamente 99%, o aproximadamente 100% de dicho polipéptido comprende a porción del Factor VIII, que es el Factor VIII de cadena simple, y una segunda porción, donde dicho Factor VIII de cadena simple es al menos 90% ó 95% idéntica a una secuencia de aminoácidos del Factor VIII que se muestra en la Tabla 2 sin una secuencia señal (aminoácidos 20 a 1457 de la SEQ ID Nº 2 o aminoácidos 20 a 2351 de la SEQ ID Nº 6). Reivindicación 73: Un método de tratar una afección de sangrado que comprende administrar una cantidad terapéuticamente efectiva de la composición de acuerdo con cualquiera de las reivindicaciones 39 - 72. Reivindicación 81: Un método de mantener el Factor VIII en una población de pacientes a un nivel superior a 1% durante al menos un día, dos días, o tres días que comprende administrar una cantidad terapéuticamente efectiva de rFVIIIFc a dicha población, donde la cantidad terapéuticamente efectiva es al menos 25 IU/kg de rFVIIIFc y donde al menos 90% de dicha población mantiene el nivel mínimo del Factor VIII al menos 1% o más. Reivindicación 105: Un método de prevenir, disminuir, o tratar un episodio de sangrado en un sujeto que comprende: (a) identifican un sujeto que tiene niveles altos de VWF por la medición del nivel de VWF en el plasma de dicho sujeto, donde un nivel de VWF de al menos aproximadamente 100 IU/dL identifica el sujeto que tiene un alto nivel de VWF; y (b) administrar al sujeto una cantidad efectiva de una proteína de FVIII de acción prolongada.
ARP120102464A 2011-07-08 2012-07-06 Polipeptidos quimericos e hibridos del factor viii, y sus metodos de uso AR087091A1 (es)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201161506015P 2011-07-08 2011-07-08
US201161522647P 2011-08-11 2011-08-11
US201161541561P 2011-09-30 2011-09-30
US201161569158P 2011-12-09 2011-12-09
US201261586443P 2012-01-13 2012-01-13
US201261622789P 2012-04-11 2012-04-11
US201261657641P 2012-06-08 2012-06-08

Publications (1)

Publication Number Publication Date
AR087091A1 true AR087091A1 (es) 2014-02-12

Family

ID=47506823

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP120102464A AR087091A1 (es) 2011-07-08 2012-07-06 Polipeptidos quimericos e hibridos del factor viii, y sus metodos de uso

Country Status (27)

Country Link
US (3) US10010622B2 (es)
EP (3) EP3513804B1 (es)
JP (5) JP2014522838A (es)
KR (2) KR102110736B1 (es)
CN (2) CN103796670A (es)
AR (1) AR087091A1 (es)
AU (3) AU2012282875B2 (es)
BR (1) BR112014000466A2 (es)
CA (1) CA2841066C (es)
CL (1) CL2014000024A1 (es)
CO (1) CO6940381A2 (es)
CY (1) CY1122900T1 (es)
DK (2) DK2729161T3 (es)
EA (1) EA029045B1 (es)
ES (2) ES2722209T3 (es)
HR (2) HRP20220639T1 (es)
HU (1) HUE043763T2 (es)
IL (2) IL230333B (es)
LT (2) LT3513804T (es)
MX (1) MX350581B (es)
MY (1) MY180714A (es)
PL (2) PL2729161T3 (es)
PT (2) PT2729161T (es)
RS (2) RS58578B1 (es)
SI (2) SI2729161T1 (es)
TW (3) TWI626947B (es)
WO (1) WO2013009627A2 (es)

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