AU2009267052B2 - Formulations of 5-fluorocytosine and uses thereof - Google Patents

Formulations of 5-fluorocytosine and uses thereof Download PDF

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Publication number
AU2009267052B2
AU2009267052B2 AU2009267052A AU2009267052A AU2009267052B2 AU 2009267052 B2 AU2009267052 B2 AU 2009267052B2 AU 2009267052 A AU2009267052 A AU 2009267052A AU 2009267052 A AU2009267052 A AU 2009267052A AU 2009267052 B2 AU2009267052 B2 AU 2009267052B2
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AU
Australia
Prior art keywords
extended release
formulation
pharmaceutical composition
auc
fed
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Ceased
Application number
AU2009267052A
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English (en)
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AU2009267052A1 (en
Inventor
Harry E. Gruber
Douglas Jolly
Kay Olmstead
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Forte Biosciences Inc
Original Assignee
Tocagen Inc
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Filing date
Publication date
Application filed by Tocagen Inc filed Critical Tocagen Inc
Publication of AU2009267052A1 publication Critical patent/AU2009267052A1/en
Priority to AU2013205004A priority Critical patent/AU2013205004B2/en
Application granted granted Critical
Publication of AU2009267052B2 publication Critical patent/AU2009267052B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/50—Hydrolases (3) acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/51—Lyases (4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10—Antimycotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y305/00—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5)
    • C12Y305/04—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5) in cyclic amidines (3.5.4)
    • C12Y305/04001—Cytosine deaminase (3.5.4.1)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Virology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AU2009267052A 2008-06-30 2009-06-30 Formulations of 5-fluorocytosine and uses thereof Ceased AU2009267052B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2013205004A AU2013205004B2 (en) 2008-06-30 2013-04-13 Formulations of 5-fluorocytosine and Uses Thereof

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US7714208P 2008-06-30 2008-06-30
US61/077,142 2008-06-30
PCT/US2009/049322 WO2010002937A1 (en) 2008-06-30 2009-06-30 Formulations of 5-fluorocytosine and uses thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2013205004A Division AU2013205004B2 (en) 2008-06-30 2013-04-13 Formulations of 5-fluorocytosine and Uses Thereof

Publications (2)

Publication Number Publication Date
AU2009267052A1 AU2009267052A1 (en) 2010-01-07
AU2009267052B2 true AU2009267052B2 (en) 2013-07-11

Family

ID=41466310

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2009267052A Ceased AU2009267052B2 (en) 2008-06-30 2009-06-30 Formulations of 5-fluorocytosine and uses thereof

Country Status (11)

Country Link
US (4) US9320738B2 (OSRAM)
EP (1) EP2306823A4 (OSRAM)
JP (3) JP6092514B2 (OSRAM)
KR (2) KR101950635B1 (OSRAM)
CN (2) CN102076215A (OSRAM)
AU (1) AU2009267052B2 (OSRAM)
BR (1) BRPI0915284B1 (OSRAM)
CA (1) CA2724740C (OSRAM)
IL (3) IL209385A (OSRAM)
MX (2) MX337213B (OSRAM)
WO (1) WO2010002937A1 (OSRAM)

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DE69940521D1 (de) 1998-10-01 2009-04-16 Univ Southern California Retrovirales genübertragungssystem und entsprechendes verwendungverfahren
US9320738B2 (en) * 2008-06-30 2016-04-26 Tocagen Inc. Formulations of 5-fluorocytosine and uses thereof
CN105624193B (zh) 2008-09-26 2021-07-13 索元生物医药(美国)有限公司 重组载体
US8829173B2 (en) 2008-09-26 2014-09-09 Tocagen Inc. Recombinant vectors
CA2764107A1 (en) 2009-06-17 2010-12-23 Tocagen Inc. Producer cells for replication competent retroviral vectors
WO2011057176A1 (en) * 2009-11-06 2011-05-12 Forest Laboratories Holding Limited Novel crystalline forms of (1s,2r)-2-(amino methyl)-n,n-diethyl-1-phenyl cyclopropane carboxamide
US9669049B2 (en) 2010-10-31 2017-06-06 Tocagen Inc. Compositions comprising gamma retrovirus vectors and methods of treating proliferative disorders
EP2670368A4 (en) * 2011-02-03 2015-04-15 Pharmedica Ltd NEW ORAL DISSOLUTION FILMS FOR INSULIN DELIVERY FOR THE TREATMENT OF DIABETES
WO2013004658A1 (en) * 2011-07-01 2013-01-10 Transgene Sa Formulations of 5-fluorocytosine and uses thereof.
CN102579450B (zh) * 2012-02-10 2013-07-24 上海市嘉定区南翔医院 5-氟尿嘧啶在制备局限性慢性湿疹治疗药物上的应用
EP2668945A1 (de) 2012-06-01 2013-12-04 Bayer Technology Services GmbH Genotyp- bzw. Phänotyp-basierte Arzeimittelformulierungen
US11065311B2 (en) 2012-10-25 2021-07-20 Denovo Biopharma Llc Retroviral vector with mini-promoter cassette
US9642921B2 (en) 2012-12-20 2017-05-09 Tocagen Inc. Cancer combination therapy and recombinant vectors
MX2018002744A (es) 2015-09-04 2018-04-13 Tocagen Inc Vectores recombinantes que comprenden peptido 2a.
CA3056603A1 (en) * 2017-03-14 2018-09-20 Memorial Sloan Kettering Cancer Center Labeling, isolation, & analysis of rna from rare cell populations
US20190380965A1 (en) * 2018-06-15 2019-12-19 Hemant N. Joshi Quick Water-Dispersible Pharmaceutical Compositions of Flucytosine
EP3955943A4 (en) * 2019-02-22 2023-10-25 Candel Therapeutics, Inc. Gmci and ddri combination therapy for treating cancer
US11483244B2 (en) 2020-03-18 2022-10-25 Marvell Israel (M.I.S.L) Ltd. Packet buffer spill-over in network devices
CN111937887B (zh) * 2020-07-15 2021-09-07 南京师范大学 5-氟-2’-脱氧尿苷在抑制和/或防治螺旋藻规模化生产中褶皱臂尾轮虫的应用

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US6667155B2 (en) * 2000-03-22 2003-12-23 Kabushiki Kaisha Toshiba Carrier for gene detection and its use for detecting validity of interferon therapy
US20050186179A1 (en) * 2000-11-17 2005-08-25 Dror Harats Promoters exhibiting endothelial cell specificity and methods of using same for regulation of angiogenesis
US20060003005A1 (en) * 2004-07-02 2006-01-05 Bruce Cao Tablet for pulsed delivery
US7186699B2 (en) * 2003-06-03 2007-03-06 Cell Genesys, Inc. Method for treating cancer by vector-mediated delivery of one or more anti-angiogenic or pro-apoptotic genes

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US6667155B2 (en) * 2000-03-22 2003-12-23 Kabushiki Kaisha Toshiba Carrier for gene detection and its use for detecting validity of interferon therapy
US20050186179A1 (en) * 2000-11-17 2005-08-25 Dror Harats Promoters exhibiting endothelial cell specificity and methods of using same for regulation of angiogenesis
US7186699B2 (en) * 2003-06-03 2007-03-06 Cell Genesys, Inc. Method for treating cancer by vector-mediated delivery of one or more anti-angiogenic or pro-apoptotic genes
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Publication number Publication date
US20200281929A1 (en) 2020-09-10
JP6170896B2 (ja) 2017-07-26
CA2724740A1 (en) 2010-01-07
KR20110039544A (ko) 2011-04-19
EP2306823A4 (en) 2012-09-26
WO2010002937A1 (en) 2010-01-07
CA2724740C (en) 2017-02-21
IL246473B (en) 2018-06-28
US10449194B2 (en) 2019-10-22
IL209385A (en) 2016-10-31
KR101813721B1 (ko) 2017-12-29
US9320738B2 (en) 2016-04-26
US20110268720A1 (en) 2011-11-03
CN102076215A (zh) 2011-05-25
JP2017214398A (ja) 2017-12-07
AU2009267052A1 (en) 2010-01-07
MX366570B (es) 2019-07-12
US20160235751A1 (en) 2016-08-18
MX2010014256A (es) 2011-07-01
JP2011526918A (ja) 2011-10-20
IL255813A (en) 2018-01-31
US11191764B2 (en) 2021-12-07
EP2306823A1 (en) 2011-04-13
KR101950635B1 (ko) 2019-05-20
BRPI0915284B1 (pt) 2020-01-14
BRPI0915284A2 (pt) 2015-08-04
US9889133B2 (en) 2018-02-13
CN107029220A (zh) 2017-08-11
US20190015414A1 (en) 2019-01-17
IL209385A0 (en) 2011-01-31
JP2015063533A (ja) 2015-04-09
KR20180004279A (ko) 2018-01-10
MX337213B (es) 2016-02-17
JP6092514B2 (ja) 2017-03-08

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