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DK2481405T3 - Nanopartikler af paclitaxel og albumin i kombination med bevacizumab mod kræft - Google Patents

Nanopartikler af paclitaxel og albumin i kombination med bevacizumab mod kræft Download PDF

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Publication number
DK2481405T3
DK2481405T3 DK12154995.0T DK12154995T DK2481405T3 DK 2481405 T3 DK2481405 T3 DK 2481405T3 DK 12154995 T DK12154995 T DK 12154995T DK 2481405 T3 DK2481405 T3 DK 2481405T3
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Denmark
Prior art keywords
variations
taxane
composition
abraxane
effective amount
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DK12154995.0T
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English (en)
Inventor
Neil P Desai
Patrick Soon-Shiong
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Abraxis Bioscience Llc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/513Organic macromolecular compounds; Dendrimers
    • A61K9/5169Proteins, e.g. albumin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/28Compounds containing heavy metals
    • A61K31/282Platinum compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • A61K31/7072Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/243Platinum; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/02Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
    • A61K35/04Tars; Bitumens; Mineral oils; Ammonium bituminosulfonate
    • 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
    • A61K38/38Albumins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • 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

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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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Oncology (AREA)
  • Nanotechnology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Optics & Photonics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (21)

1. Sammensætning omfattende nanopartikler, omfattende en virksom mængde af taxan og et bærerprotein, til anvendelse i en fremgangsmåde til behandling af kræft hos et individ, hvor nanopartikelsammensætningen anvendes i kombination med en virksom mængde af et anti-VEGF-antistof, hvor den virksomme mængde af taxan i nanopartikelsammensætningen er mellem cirka 45 mg/m2 og cirka 350 mg/m2, og hvor den virksomme mængde af anti-VEGF-antistoffet er mellem cirka 1 mg/kg og cirka 10 mg/kg, hvor kræften er brystkræft eller æggestokkræft.
2. Sammensætning til anvendelse ifølge krav 1, hvor sammensætningen omfattende nanopartikler, omfattende taxan og et bærerprotein, indgives ugentligt.
3. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-2, hvor kræften er metastatisk brystkræft eller metastatisk æggestokkræft.
4. Sammensætning til anvendelse ifølge krav 3, hvor den metastatiske brystkræft er refraktær over for taxan eller intensivt forbehandlet med taxan og/eller anthracyclin.
5. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-4, hvor den virksomme mængde af anti-VEGF-antistoffet er en mængde, der er virksom til at hæmme taxan-medieret induktion af VEGF in vivo.
6. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-5, hvor den virksomme mængde af anti-VEGF-antistoffet er cirka 6 mg/kg eller er cirka 8 mg/kg eller er cirka 10 mg/kg.
7. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-6, hvor den virksomme mængde af taxan i nanopartikelsammensætningen er mellem cirka 80 mg/m2 til cirka 150 mg/m2, eller mellem cirka 200 mg/m2 til cirka 350 mg/m2 taxan i nanopartikelsammensætningen.
8. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-7, hvor nanopartikelsammensætningen og anti-VEGF-antistoffet indgives samtidigt til individet.
9. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-7, hvor nanopartikelsammensætningen og anti-VEGF-antistoffet indgives sekventielt til individet.
10. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-7, hvor nanopartikelsammensætningen indgives til individet i mindst en cyklus før indgivelsen af anti-VEGF-antistoffet.
11. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-7, hvor indgivelsen af nanopartikelsammensætningen til individet efterfølges af indgivelsen af anti-VEGF-antistoffet i mindst cirka 3 uger.
12. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1-7, hvor nanopartikelsammensætningen og anti-VEGF-antistoffet er i den samme sammensætning.
13. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1- 12, hvor den gennemsnitlige diameter af nanopartiklerne i sammensætningen ikke er mere end cirka 200 nm.
14. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1- 13, hvor bærerproteinet er albumin.
15. Sammensætning til anvendelse ifølge krav 14, hvor vægtforholdet mellem albuminet og taxanet i nanopartikelsammensætningen er mindre end cirka 9:1.
16. Sammensætning til anvendelse ifølge krav 14 eller 15, hvor nanopartikelsammensætningen omfatter taxan coatet med albumin.
17. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 14-16, hvor albuminet er humant albumin eller humant serumalbumin.
18. Sammensætning til anvendelse ifølge krav 1-17, hvor taxanet er pacli-taxel.
19. Sammensætning til anvendelse ifølge krav 1-18, hvor anti-VEGF-antistoffet er bevacizumab.
20. Sammensætning til anvendelse ifølge krav 1-19, hvor fremgangsmåden yderligere omfatter indgivelse af en virksom mængde af mindst et andet kemoterapeutisk middel.
21. Sammensætning til anvendelse ifølge krav 1-20, hvor individet er et menneske.
DK12154995.0T 2006-11-06 2007-11-06 Nanopartikler af paclitaxel og albumin i kombination med bevacizumab mod kræft DK2481405T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/594,417 US20070166388A1 (en) 2005-02-18 2006-11-06 Combinations and modes of administration of therapeutic agents and combination therapy
EP07839976.3A EP2097078B1 (en) 2006-11-06 2007-11-06 Nanoparticles of paclitaxel and albumin in combination with bevacizumab against cancer

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DK2481405T3 true DK2481405T3 (da) 2016-06-06

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DK12154995.0T DK2481405T3 (da) 2006-11-06 2007-11-06 Nanopartikler af paclitaxel og albumin i kombination med bevacizumab mod kræft

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US (1) US20070166388A1 (da)
EP (3) EP2481405B1 (da)
JP (3) JP5931323B2 (da)
KR (4) KR101857142B1 (da)
CN (2) CN101573108A (da)
AU (1) AU2007317859B2 (da)
BR (1) BRPI0718528A2 (da)
CA (1) CA2668607A1 (da)
CY (2) CY1115271T1 (da)
DK (2) DK2097078T3 (da)
ES (2) ES2576289T3 (da)
HK (1) HK1173976A1 (da)
HU (1) HUE028472T2 (da)
IL (2) IL198576A (da)
MX (1) MX2009004803A (da)
NO (1) NO343908B1 (da)
NZ (1) NZ576856A (da)
PL (2) PL2481405T3 (da)
PT (2) PT2481405E (da)
RU (2) RU2009121568A (da)
SI (2) SI2481405T1 (da)
WO (1) WO2008057562A1 (da)
ZA (1) ZA200903132B (da)

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