HRP20240164T1 - Pripravci i postupci za liječenje aktivne tuberkulozne infekcije mikobakterijama - Google Patents

Pripravci i postupci za liječenje aktivne tuberkulozne infekcije mikobakterijama Download PDF

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HRP20240164T1
HRP20240164T1 HRP20240164TT HRP20240164T HRP20240164T1 HR P20240164 T1 HRP20240164 T1 HR P20240164T1 HR P20240164T T HRP20240164T T HR P20240164TT HR P20240164 T HRP20240164 T HR P20240164T HR P20240164 T1 HRP20240164 T1 HR P20240164T1
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vaccine
tuberculosis infection
use according
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alkyl
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HRP20240164TT
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Steven G. Reed
Rhea N. Coler
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Access To Advanced Health Institute
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/04Mycobacterium, e.g. Mycobacterium tuberculosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4409Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • A61P31/06Antibacterial agents for tuberculosis
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Pulmonology (AREA)
  • Communicable Diseases (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Claims (14)

1. Cjepivo koje sadrži farmaceutski pripravak koji sadrži fuzijski polipeptid, pri čemu fuzijski polipeptid: (a) sadrži kombinaciju antigena Rv1813, Rv3620 i Rv2608 iz vrsta mikobakterija, pri čemu antigen Rv1813 sadrži slijed aminokiselina SEQ ID NO: 5, antigen Rv3620 sadrži slijed aminokiselina SEQ ID NO: 6, a antigen Rv2608 sadrži slijed aminokiselina SEQ ID NO: 7 i antigeni su kovalentno povezani, ili (b) sadrži kombinaciju antigena Rv1813, Rv3620, Rv2608 i Rv3619 iz vrsta mikobakterija, pri čemu antigen Rv1813 sadrži slijed aminokiselina SEQ ID NO: 5, antigen Rv3620 sadrži slijed aminokiselina SEQ ID NO: 6, antigen Rv2608 sadrži slijed aminokiselina SEQ ID NO: 7, a antigen Rv3619 sadrži slijed aminokiselina SEQ ID NO: 8 i antigeni su kovalentno povezani, ili, (c) izabran je iz polipeptida koji sadrži slijed aminokiselina naveden u SEQ ID NO: 1, polipeptida koji sadrži slijed aminokiselina naveden u SEQ ID NO: 2, ili polipeptida koji sadrži slijed aminokiselina naveden u SEQ ID NO: 3 ili SEQ ID NO: 4, pri čemu cjepivo sadrži adjuvant, za upotrebu u postupku liječenja aktivne tuberkulozne infekcije u sisavaca, pri čemu je aktivna tuberkulozna infekcija naznačena time da se mikobakterije tuberkuloze umnožavaju, razmnožavaju, šire ili aktivno množe eksponencijalnom, logaritamskom ili polulogaritamskom brzinom u organu sisavca i pri čemu je navedeno liječenje u kombinaciji s jednim ili više kemoterapijskih agensa učinkovito protiv infekcije bakterijom M. tuberculosis.
2. Cjepivo za upotrebu prema zahtjevu 1, pri čemu cjepivo potiče imunosni odgovor na tuberkulozu i pri čemu liječenje umanjuje vrijeme potrebno za djelovanje kemoterapije protiv aktivne tuberkulozne infekcije.
3. Cjepivo za upotrebu prema zahtjevu 2, pri čemu je vrijeme potrebno za djelovanje kemoterapije umanjeno na najviše 3 mjeseca, 5 mjeseci ili 7 mjeseci.
4. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu se aktivna tuberkulozna infekcija dovodi u vezu s kliničkim simptomom slabosti, umora, groznice, zimice, gubitka tjelesne težine, gubitka apetita, anoreksije ili noćnog znojenja ili bilo kojom kombinacijom tih simptoma.
5. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je aktivna tuberkulozna infekcija aktivna primarna infekcija bakterijom M. tuberculosis, reaktivacijska tuberkulozna infekcija, plućna aktivna tuberkulozna infekcija ili višestruko rezistentna (MDR) infekcija bakterijom M. tuberculosis.
6. Cjepivo za upotrebu prema zahtjevu 5, pri čemu se plućna aktivna tuberkulozna infekcija dovodi u vezu s kliničkim simptomom ustrajnog kašlja, guste sluzi, boli u prsima ili hemoptize ili bilo kojom kombinacijom tih simptoma.
7. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je aktivna tuberkulozna infekcija utvrđena testom odabranim iz skupine koja se sastoji od testa bojenja acidorezistentnih bacila (AFS), testa bakterijskih kultura, testa otpuštanja interferona gama (IGR), kožnog testa i bojenja unutarstaničnih citokina u punoj krvi ili izoliranih mononuklearnih stanica iz periferne krvi nakon antigenske stimulacije.
8. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je sisavac prethodno imuniziran bacilom Calmette-Guérin (BCG).
9. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je jedan ili više kemoterapijskih agensa amikacin, aminosalicilna kiselina, kapreomicin, cikloserin, etambutol, etionamid, izoniazid, kanamicin, pirazinamid, rifamicini, streptomicin, ofloksacin, ciprofloksacin, klaritromicin, azitromicin ili fluorokinoloni ili kombinacija tih agensa.
10. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu: sisavac prvo prima jedan ili više kemoterapijskih agensa tijekom duljeg vremenskog razdoblja, a potom primi terapijsko cjepivo, sisavac prvo primi terapijsko cjepivo, a potom prima jedan ili više kemoterapijskih agensa tijekom duljeg vremenskog razdoblja ili primjena jednog ili više kemoterapijskih agensa i terapijskog cjepiva je istodobna.
11. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je adjuvant glukopiranozil lipid A (GLA), koji ima sljedeću strukturu: [image] pri čemu su R1, R3, R5 i R6 alkil C11-C20, a R2 i R4 alkil C9-C20.
12. Cjepivo za upotrebu prema zahtjevu 11, pri čemu su: R1, R3, R5 i R6 alkil C11-C14, a R2 i R4 alkil C12-15, R1, R3, R5 i R6 su alkil C11, a R2 i R4 alkil C13 ili su R1, R3, R5 i R6 alkil C11, a R2 i R4 alkil C9.
13. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu je sisavac čovjek.
14. Cjepivo za upotrebu prema bilo kojem od prethodnih zahtjeva, pri čemu sisavac prima terapijsko cjepivo jednom ili više puta zaredom nakon početne primjene, pri čemu tuberkulozna infekcija koja ostane u sisavcu nakon jedne primjene ili više primjena zaredom može biti, ali ne mora, aktivna tuberkulozna infekcija.
HRP20240164TT 2012-08-03 2013-08-02 Pripravci i postupci za liječenje aktivne tuberkulozne infekcije mikobakterijama HRP20240164T1 (hr)

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Application Number Priority Date Filing Date Title
US201261679612P 2012-08-03 2012-08-03
US201361791213P 2013-03-15 2013-03-15
PCT/US2013/053482 WO2014042780A1 (en) 2012-08-03 2013-08-02 Compositions and methods for treating an active mycobacterium tuberculosis infection
EP13836324.7A EP2879701B1 (en) 2012-08-03 2013-08-02 Compositions and methods for treating an active mycobacterium tuberculosis infection

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US (2) US20150182612A1 (hr)
EP (2) EP2879701B1 (hr)
JP (1) JP2015525784A (hr)
CN (1) CN104812404A (hr)
BR (1) BR112015002483A2 (hr)
ES (1) ES2969734T3 (hr)
HR (1) HRP20240164T1 (hr)
MX (1) MX2015001557A (hr)
PT (1) PT2879701T (hr)
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EP2879701A1 (en) 2015-06-10
ZA201501242B (en) 2017-08-30
JP2015525784A (ja) 2015-09-07
RU2659149C2 (ru) 2018-06-28
PT2879701T (pt) 2024-02-12
EP2879701A4 (en) 2016-01-20
ZA201702091B (en) 2018-12-19
US20150182612A1 (en) 2015-07-02
ES2969734T3 (es) 2024-05-22
RU2015107435A (ru) 2016-09-27
CN104812404A (zh) 2015-07-29
EP2879701B1 (en) 2023-11-15
BR112015002483A2 (pt) 2017-11-07
US11369672B2 (en) 2022-06-28
WO2014042780A1 (en) 2014-03-20
MX2015001557A (es) 2015-10-08
US20200038498A1 (en) 2020-02-06
EP4299138A2 (en) 2024-01-03

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