HRP20231732T1 - Režim doziranja pegiliranog interferona - Google Patents

Režim doziranja pegiliranog interferona Download PDF

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Publication number
HRP20231732T1
HRP20231732T1 HRP20231732TT HRP20231732T HRP20231732T1 HR P20231732 T1 HRP20231732 T1 HR P20231732T1 HR P20231732T T HRP20231732T T HR P20231732TT HR P20231732 T HRP20231732 T HR P20231732T HR P20231732 T1 HRP20231732 T1 HR P20231732T1
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HR
Croatia
Prior art keywords
interferon
treatment period
pegylated type
period
treatment
Prior art date
Application number
HRP20231732TT
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English (en)
Inventor
Christoph Klade
Oleh ZAGRIJTSCHUK
Ko-Chung Lin
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Pharmaessentia Corporation
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Publication date
Application filed by Pharmaessentia Corporation filed Critical Pharmaessentia Corporation
Publication of HRP20231732T1 publication Critical patent/HRP20231732T1/hr

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    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • 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
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • A61K38/212IFN-alpha
    • 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
    • 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
    • A61P19/00Drugs for skeletal disorders
    • A61P19/04Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • 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
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/555Interferons [IFN]
    • 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
    • C07K14/52Cytokines; Lymphokines; Interferons
    • C07K14/555Interferons [IFN]
    • C07K14/56IFN-alpha

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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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Communicable Diseases (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Claims (6)

1. Pegilirani interferon tipa I za uporabu u liječenju mijeloproliferativne bolesti kod subjekta, pri čemu pegilirani interferon tipa I je [image] pri čemu mPEG ima molekulsku težinu od 20 kD i IFN je interferon-α2b i pri čemu se doza od 50 do 540 µg pegiliranog interferona tipa I primjenjuje supkutano na subjekta kojem je to potrebno u prvom redovnom intervalu od 2 tjedna tokom prvog perioda liječenja dužeg od 1 godine, nakon čega slijedi drugi period liječenja u drugom intervalu primjene svaka 4 tjedna, pri čemu mijeloproliferativna bolest je policitemija vera i pri čemu doza prvog i drugog intervala primjene ostaje nepromijenjena.
2. Pegilirani interferon tipa I za uporabu prema patentnom zahtjevu 1, naznačen time što je drugi period liječenja najmanje 2 do 12 mjeseci, ili je period liječenja najmanje 12 mjeseci.
3. Pegilirani interferon tipa I za uporabu prema patentnom zahtjevu 2, pri čemu je ukupna količina pegiliranog interferona tipa I primijenjena na subjekta u danom periodu tokom drugog perioda liječenja niža od ukupne količine primijenjene u danom periodu tokom prvog perioda liječenja.
4. Pegilirani interferon tipa I za uporabu prema patentnom zahtjevu 3, pri čemu se prvi period liječenja nastavlja sve dok subjekt ne pokaže (i) normalizaciju najmanje jednog hematološkog parametra i/ili (ii) najmanje 50% smanjenje JAK2V617F alelnog opterećenja, posebno najmanje jedan hematološki parametar je hematokrit, broj bijelih krvnih zrnaca (WBC) ili broj trombocita.
5. Pegilirani interferon tipa I za uporabu prema patentnom zahtjevu 4, naznačen time što je hematokrit manji od 45%, WBC je manji ili jednak 10 × 109/L i broj trombocita je manji ili jednak 400 × 109/L.
6. Pegilirani interferon tipa I za uporabu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time što se konstantna doza pegiliranog interferona tipa I primjenjuje tokom prvog i/ili drugog perioda liječenja, posebno ista konstantna doza se primjenjuje tokom prvog perioda liječenja i drugog perioda liječenja, ili je konstantna doza primijenjena tokom drugog perioda liječenja niža od konstantne doze primijenjene tokom prvog perioda liječenja.
HRP20231732TT 2014-11-06 2015-11-06 Režim doziranja pegiliranog interferona HRP20231732T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14192114 2014-11-06
EP15857703.1A EP3215193B1 (en) 2014-11-06 2015-11-06 Dosage regimen for pegylated interferon
PCT/US2015/059410 WO2016073825A1 (en) 2014-11-06 2015-11-06 Dosage regimen for pegylated interferon

Publications (1)

Publication Number Publication Date
HRP20231732T1 true HRP20231732T1 (hr) 2024-03-15

Family

ID=51945707

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20231732TT HRP20231732T1 (hr) 2014-11-06 2015-11-06 Režim doziranja pegiliranog interferona

Country Status (30)

Country Link
US (2) US11559567B2 (hr)
EP (2) EP3215193B1 (hr)
JP (2) JP6820841B2 (hr)
KR (2) KR102540109B1 (hr)
CN (1) CN107530403A (hr)
AU (1) AU2015342908B2 (hr)
BR (1) BR112017009193A2 (hr)
CA (1) CA2964390A1 (hr)
CL (1) CL2017001088A1 (hr)
DK (1) DK3215193T3 (hr)
EA (1) EA037151B1 (hr)
ES (1) ES2966888T3 (hr)
FI (1) FI3215193T3 (hr)
HK (1) HK1243627A1 (hr)
HR (1) HRP20231732T1 (hr)
HU (1) HUE064909T2 (hr)
IL (1) IL251627B (hr)
LT (1) LT3215193T (hr)
MX (1) MX2017005244A (hr)
MY (1) MY191506A (hr)
NZ (1) NZ730924A (hr)
PH (1) PH12017500617A1 (hr)
PL (1) PL3215193T3 (hr)
PT (1) PT3215193T (hr)
RS (1) RS65015B1 (hr)
SG (1) SG11201702798PA (hr)
SI (1) SI3215193T1 (hr)
TW (1) TWI737583B (hr)
WO (1) WO2016073825A1 (hr)
ZA (1) ZA201702704B (hr)

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WO2021216801A1 (en) * 2020-04-22 2021-10-28 Southlake Pharmaceuticals, Inc. Pegylated interferon tau and compositions and methods thereof

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Also Published As

Publication number Publication date
KR20230079520A (ko) 2023-06-07
HUE064909T2 (hu) 2024-04-28
KR102540109B1 (ko) 2023-06-02
MX2017005244A (es) 2017-08-18
US11559567B2 (en) 2023-01-24
BR112017009193A2 (pt) 2018-01-30
EP3215193A1 (en) 2017-09-13
TW201618808A (zh) 2016-06-01
JP2021001184A (ja) 2021-01-07
WO2016073825A1 (en) 2016-05-12
JP6820841B2 (ja) 2021-01-27
SI3215193T1 (sl) 2024-02-29
EA201790991A1 (ru) 2017-11-30
HK1243627A1 (zh) 2018-07-20
US20230131552A1 (en) 2023-04-27
EP3215193B1 (en) 2023-10-04
EP3215193A4 (en) 2018-07-25
ZA201702704B (en) 2020-10-28
PL3215193T3 (pl) 2024-03-18
JP2017533192A (ja) 2017-11-09
AU2015342908A1 (en) 2017-05-04
NZ730924A (en) 2022-04-29
AU2015342908B2 (en) 2021-06-24
CA2964390A1 (en) 2016-05-12
PT3215193T (pt) 2023-12-15
US20170326206A1 (en) 2017-11-16
DK3215193T3 (da) 2024-01-08
RS65015B1 (sr) 2024-01-31
FI3215193T3 (fi) 2023-12-28
EP4282485A2 (en) 2023-11-29
SG11201702798PA (en) 2017-05-30
CN107530403A (zh) 2018-01-02
EP4282485A3 (en) 2024-01-17
IL251627B (en) 2021-12-01
CL2017001088A1 (es) 2018-01-12
KR20170083074A (ko) 2017-07-17
LT3215193T (lt) 2024-01-25
EA037151B1 (ru) 2021-02-11
TWI737583B (zh) 2021-09-01
PH12017500617A1 (en) 2017-09-04
MY191506A (en) 2022-06-28
IL251627A0 (en) 2017-06-29
ES2966888T3 (es) 2024-04-24

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