WO2018069536A1 - Treatment of cholangiocarcinoma with tpcs-2a induced photochemical internalisation of gemcitabine - Google Patents

Treatment of cholangiocarcinoma with tpcs-2a induced photochemical internalisation of gemcitabine Download PDF

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Publication number
WO2018069536A1
WO2018069536A1 PCT/EP2017/076257 EP2017076257W WO2018069536A1 WO 2018069536 A1 WO2018069536 A1 WO 2018069536A1 EP 2017076257 W EP2017076257 W EP 2017076257W WO 2018069536 A1 WO2018069536 A1 WO 2018069536A1
Authority
WO
WIPO (PCT)
Prior art keywords
gemcitabine
tpcs
cytotoxic agent
dose
administered
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP2017/076257
Other languages
English (en)
French (fr)
Inventor
Anders HØGSET
Per Edvard WALDAY
Pål Kristian SELBO
Kristin EIVINDVIK
Lena FINNESAND
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PCI Biotech AS
Original Assignee
PCI Biotech AS
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
Priority claimed from GBGB1617526.7A external-priority patent/GB201617526D0/en
Priority claimed from GBGB1704719.2A external-priority patent/GB201704719D0/en
Priority to KR1020197013250A priority Critical patent/KR20190068573A/ko
Priority to EP17791004.9A priority patent/EP3525783B1/en
Priority to ES17791004T priority patent/ES2841941T3/es
Priority to CA3040344A priority patent/CA3040344A1/en
Priority to US16/341,186 priority patent/US20200338044A1/en
Priority to DK17791004.9T priority patent/DK3525783T3/da
Application filed by PCI Biotech AS filed Critical PCI Biotech AS
Priority to CN201780073846.XA priority patent/CN110022874A/zh
Priority to RU2019109682A priority patent/RU2019109682A/ru
Priority to JP2019519974A priority patent/JP2019530718A/ja
Priority to AU2017342086A priority patent/AU2017342086A1/en
Priority to SG11201903057XA priority patent/SG11201903057XA/en
Priority to PL17791004T priority patent/PL3525783T3/pl
Publication of WO2018069536A1 publication Critical patent/WO2018069536A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/409—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having four such rings, e.g. porphine derivatives, bilirubin, biliverdine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0057—Photodynamic therapy with a photosensitizer, i.e. agent able to produce reactive oxygen species upon exposure to light or radiation, e.g. UV or visible light; photocleavage of nucleic acids with an agent
    • A61K41/0071—PDT with porphyrins having exactly 20 ring atoms, i.e. based on the non-expanded tetrapyrrolic ring system, e.g. bacteriochlorin, chlorin-e6, or phthalocyanines
    • 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
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds 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
    • A61K31/7064—Compounds 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
    • A61K31/7068—Compounds 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/243—Platinum; Compounds thereof
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • 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

Definitions

  • step iii) is performed in cycles as described hereinbefore, in particular multiple cycies of step iii) are performed (before commencing to step iv)) and in each of these cycles the gemcitabine and/or another cytotoxic agent such as cisplatin is administered twice or more.
  • EXAMPLE 2 In vivo (mice) evaluation of PCI with gemcitabine to provide an anti-cancer effect
  • PCI photochemical internalisation
  • a second PCI treatment was conducted approximately 9 months after the first PCI treatment using the same dose parameters (Amphinex 0.06mg/kg and a light dose of 15 J/cm).
  • Patient 6 in cohort 2 also received a second PCI treatment approximately 17 months after the first PCI treatment using Amphinex at 0.25 mg/kg and a light dose of 30 J/cm.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Oncology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PCT/EP2017/076257 2016-10-14 2017-10-13 Treatment of cholangiocarcinoma with tpcs-2a induced photochemical internalisation of gemcitabine Ceased WO2018069536A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
SG11201903057XA SG11201903057XA (en) 2016-10-14 2017-10-13 Treatment of cholangiocarcinoma with tpcs-2a induced photochemical internalisation of gemcitabine
PL17791004T PL3525783T3 (pl) 2016-10-14 2017-10-13 Leczenie raka dróg żółciowych fotochemiczną internalizacją gemcytabiny indukowaną TPCS-2A
CN201780073846.XA CN110022874A (zh) 2016-10-14 2017-10-13 以tpcs-2a诱导的吉西他滨光化学内在化治疗胆管癌
ES17791004T ES2841941T3 (es) 2016-10-14 2017-10-13 Tratamiento del colangiocarcinoma a través de la internalización fotoquímica de gemcitabina inducida por TPCS2a
CA3040344A CA3040344A1 (en) 2016-10-14 2017-10-13 Treatment of cholangiocarcinoma with tpcs-2a induced photochemical internalisation of gemcitabine
US16/341,186 US20200338044A1 (en) 2016-10-14 2017-10-13 Treatment of cholangiocarcinoma with tpcs-2a induced photochemical internalisation of gemcitabine
DK17791004.9T DK3525783T3 (da) 2016-10-14 2017-10-13 Behandling af cholangiocarcinom med tpcs-2a-induceret fotokemisk internalisering af gemcitabin
KR1020197013250A KR20190068573A (ko) 2016-10-14 2017-10-13 젬시타빈의 tpcs-2a 유도된 광화학 내재화로의 담관암의 치료
EP17791004.9A EP3525783B1 (en) 2016-10-14 2017-10-13 Treatment of cholangiocarcinoma with tpcs-2a induced photochemical internalisation of gemcitabine
RU2019109682A RU2019109682A (ru) 2016-10-14 2017-10-13 Лечение холангиокарциномы с применением tpcs-2-индуцированной фотохимической интернализации гемцитабина
JP2019519974A JP2019530718A (ja) 2016-10-14 2017-10-13 ゲムシタビンのＴＰＣＳ−２ａ誘導性光化学的内在化を用いた胆管癌の処置
AU2017342086A AU2017342086A1 (en) 2016-10-14 2017-10-13 Treatment of cholangiocarcinoma with TPCS-2a induced photochemical internalisation of gemcitabine

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GBGB1617526.7A GB201617526D0 (en) 2016-10-14 2016-10-14 Method
GB1617526.7 2016-10-14
GB1704719.2 2017-03-24
GBGB1704719.2A GB201704719D0 (en) 2017-03-24 2017-03-24 Method

Publications (1)

Publication Number Publication Date
WO2018069536A1 true WO2018069536A1 (en) 2018-04-19

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PCT/EP2017/076257 Ceased WO2018069536A1 (en) 2016-10-14 2017-10-13 Treatment of cholangiocarcinoma with tpcs-2a induced photochemical internalisation of gemcitabine

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US (1) US20200338044A1 (enExample)
EP (1) EP3525783B1 (enExample)
JP (1) JP2019530718A (enExample)
KR (1) KR20190068573A (enExample)
CN (1) CN110022874A (enExample)
AU (1) AU2017342086A1 (enExample)
CA (1) CA3040344A1 (enExample)
DK (1) DK3525783T3 (enExample)
ES (1) ES2841941T3 (enExample)
PL (1) PL3525783T3 (enExample)
RU (1) RU2019109682A (enExample)
SG (1) SG11201903057XA (enExample)
WO (1) WO2018069536A1 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021048412A1 (en) * 2019-09-11 2021-03-18 Seald As Combination therapies comprising panobinostat for the treatment of cholangiocarcinoma
WO2021048419A1 (en) * 2019-09-11 2021-03-18 Seald As Combination therapies comprising trametinib for the treatment of cholangiocarcinoma
WO2024160824A1 (en) 2023-01-30 2024-08-08 Pci Biotech As Photochemical internalization of mycobacterium bovis bacille calmette-guérin for use in the treatment of cancer

Citations (5)

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Publication number Priority date Publication date Assignee Title
WO1996007432A1 (en) 1994-09-08 1996-03-14 Radiumhospitalets Forskningsstiftelse Transfer of molecules into the cytosol of cells
WO2000054802A2 (en) 1999-03-15 2000-09-21 Photocure Asa Method of expressing antigens on the surface of antigen presenting cells by photochemical internalization
WO2002044396A1 (en) 2000-11-29 2002-06-06 Pci Biotech As Photochemical internalization for delivery of molecules into the cytosol
WO2003020309A2 (en) 2001-08-30 2003-03-13 Pci Biotech As Compound
WO2011018635A2 (en) 2009-08-14 2011-02-17 Pci Biotech As Photosensitizing compositions

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0914286D0 (en) * 2009-08-14 2009-09-30 Pci Biotech As Method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996007432A1 (en) 1994-09-08 1996-03-14 Radiumhospitalets Forskningsstiftelse Transfer of molecules into the cytosol of cells
WO2000054802A2 (en) 1999-03-15 2000-09-21 Photocure Asa Method of expressing antigens on the surface of antigen presenting cells by photochemical internalization
WO2002044396A1 (en) 2000-11-29 2002-06-06 Pci Biotech As Photochemical internalization for delivery of molecules into the cytosol
WO2003020309A2 (en) 2001-08-30 2003-03-13 Pci Biotech As Compound
WO2011018635A2 (en) 2009-08-14 2011-02-17 Pci Biotech As Photosensitizing compositions

Non-Patent Citations (13)

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ALEJANDRA MARTINEZ DE PINILLOS BAYONA ET AL: "Enhancing the efficacy of cytotoxic agents for cancer therapy using photochemical internalisation", INTERNATIONAL JOURNAL OF CANCER, vol. 138, no. 5, 23 March 2015 (2015-03-23), US, pages 1049 - 1057, XP055431897, ISSN: 0020-7136, DOI: 10.1002/ijc.29510 *
ANONYMOUS: "A Phase I/II Study Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas NCT01900158", CLINICALTRIALS.GOV, 13 October 2016 (2016-10-13), pages 1 - 7, XP055431824, Retrieved from the Internet <URL:https://www.clinicaltrials.gov/ct2/show/record/NCT01900158?term=amphinex&cond=cholangiocarcinoma&rank=1> [retrieved on 20171205] *
ANONYMOUS: "A trial looking at photochemical internalisation (PCI) for advanced bile duct cancer", 20 October 2016 (2016-10-20), pages 1 - 6, XP055432727, Retrieved from the Internet <URL:http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-photochemical-internalisation-pci-for-advanced-bile-duct-cancer#undefined> [retrieved on 20171207] *
ANONYMOUS: "Positive results on bile duct cancer from PCI Biotech", OSLO CANCER CLUSTER, 24 April 2014 (2014-04-24), pages 1 - 3, XP055431839, Retrieved from the Internet <URL:http://oslocancercluster.no/2014/04/24/positive-results-on-bile-duct-cancer-from-pci-biotech/> [retrieved on 20171205] *
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PIGNOCHINO ET AL., BMC CANCER, vol. 10, 2010, pages 631
RICHARD STURGESS ET AL: "PHASE I STUDY WITH PHOTOCHEMICAL INTERNALISATION (PCI)- A NOVEL TECHNOLOGY FOR TREATMENT OF PERIHILAR CHOLANGIOCARCINOMA 1", 14 October 2016 (2016-10-14), pages 1 - 11, XP055431840, Retrieved from the Internet <URL:http://ammf.org.uk/wp-content/uploads/2016/10/Phase-I-CCA-UEGW-October-2016.pdf> [retrieved on 20171205] *
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STURGESS R ET AL: "Phase I clinical study with photochemical internalisation, a novel technology for treatment of perihilar cholangiocarcinoma", JOURNAL OF HEPATOLOGY, vol. 66, no. 1, 21 April 2017 (2017-04-21), XP085012364, ISSN: 0168-8278, DOI: 10.1016/S0168-8278(17)31282-5 *
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021048412A1 (en) * 2019-09-11 2021-03-18 Seald As Combination therapies comprising panobinostat for the treatment of cholangiocarcinoma
WO2021048419A1 (en) * 2019-09-11 2021-03-18 Seald As Combination therapies comprising trametinib for the treatment of cholangiocarcinoma
WO2024160824A1 (en) 2023-01-30 2024-08-08 Pci Biotech As Photochemical internalization of mycobacterium bovis bacille calmette-guérin for use in the treatment of cancer

Also Published As

Publication number Publication date
EP3525783A1 (en) 2019-08-21
DK3525783T3 (da) 2021-01-18
SG11201903057XA (en) 2019-05-30
US20200338044A1 (en) 2020-10-29
ES2841941T3 (es) 2021-07-12
AU2017342086A1 (en) 2019-05-09
JP2019530718A (ja) 2019-10-24
PL3525783T3 (pl) 2021-04-19
KR20190068573A (ko) 2019-06-18
RU2019109682A3 (enExample) 2021-02-15
CA3040344A1 (en) 2018-04-19
CN110022874A (zh) 2019-07-16
EP3525783B1 (en) 2020-12-16
RU2019109682A (ru) 2020-11-16

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