CA3052973C - Method of use for therapeutic bone agents - Google Patents
Method of use for therapeutic bone agents Download PDFInfo
- Publication number
- CA3052973C CA3052973C CA3052973A CA3052973A CA3052973C CA 3052973 C CA3052973 C CA 3052973C CA 3052973 A CA3052973 A CA 3052973A CA 3052973 A CA3052973 A CA 3052973A CA 3052973 C CA3052973 C CA 3052973C
- Authority
- CA
- Canada
- Prior art keywords
- mci
- patient
- doses
- composition
- bone
- 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.)
- Active
Links
- 238000000034 method Methods 0.000 title claims description 17
- 210000000988 bone and bone Anatomy 0.000 title description 16
- 230000001225 therapeutic effect Effects 0.000 title description 3
- KZUNJOHGWZRPMI-AKLPVKDBSA-N samarium-153 Chemical compound [153Sm] KZUNJOHGWZRPMI-AKLPVKDBSA-N 0.000 claims description 93
- 239000000203 mixture Substances 0.000 claims description 43
- 230000000694 effects Effects 0.000 claims description 38
- 238000011282 treatment Methods 0.000 claims description 22
- 239000013522 chelant Substances 0.000 claims description 18
- 238000009472 formulation Methods 0.000 claims description 18
- 206010028980 Neoplasm Diseases 0.000 claims description 17
- 210000001185 bone marrow Anatomy 0.000 claims description 9
- 238000009825 accumulation Methods 0.000 claims description 7
- 230000037396 body weight Effects 0.000 claims description 7
- 150000003839 salts Chemical class 0.000 claims description 7
- 206010006002 Bone pain Diseases 0.000 claims description 5
- 239000002253 acid Substances 0.000 claims description 5
- 239000002904 solvent Substances 0.000 claims description 4
- 206010065553 Bone marrow failure Diseases 0.000 claims description 3
- 150000001298 alcohols Chemical class 0.000 claims description 2
- 239000000872 buffer Substances 0.000 claims description 2
- 239000003085 diluting agent Substances 0.000 claims description 2
- 150000002334 glycols Chemical class 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 230000002285 radioactive effect Effects 0.000 abstract description 17
- 239000012535 impurity Substances 0.000 abstract description 16
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 229940120146 EDTMP Drugs 0.000 description 18
- 239000003814 drug Substances 0.000 description 12
- 229940079593 drug Drugs 0.000 description 12
- 230000004907 flux Effects 0.000 description 11
- 206010005949 Bone cancer Diseases 0.000 description 10
- 208000018084 Bone neoplasm Diseases 0.000 description 10
- 238000004519 manufacturing process Methods 0.000 description 10
- 229910052751 metal Inorganic materials 0.000 description 9
- 239000002184 metal Substances 0.000 description 9
- 239000012217 radiopharmaceutical Substances 0.000 description 9
- 241000282472 Canis lupus familiaris Species 0.000 description 8
- NFDRPXJGHKJRLJ-UHFFFAOYSA-N edtmp Chemical compound OP(O)(=O)CN(CP(O)(O)=O)CCN(CP(O)(O)=O)CP(O)(O)=O NFDRPXJGHKJRLJ-UHFFFAOYSA-N 0.000 description 8
- 229940121896 radiopharmaceutical Drugs 0.000 description 7
- 230000002799 radiopharmaceutical effect Effects 0.000 description 7
- SZZACTGRBZTAKY-NKNBZPHVSA-F pentasodium;samarium-153(3+);n,n,n',n'-tetrakis(phosphonatomethyl)ethane-1,2-diamine Chemical group [Na+].[Na+].[Na+].[Na+].[Na+].[153Sm+3].[O-]P([O-])(=O)CN(CP([O-])([O-])=O)CCN(CP([O-])([O-])=O)CP([O-])([O-])=O SZZACTGRBZTAKY-NKNBZPHVSA-F 0.000 description 6
- 229940087876 quadramet Drugs 0.000 description 6
- 201000011510 cancer Diseases 0.000 description 5
- 210000004027 cell Anatomy 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 239000002738 chelating agent Substances 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 239000003446 ligand Substances 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- ABLZXFCXXLZCGV-UHFFFAOYSA-N Phosphorous acid Chemical compound OP(O)=O ABLZXFCXXLZCGV-UHFFFAOYSA-N 0.000 description 3
- 238000003384 imaging method Methods 0.000 description 3
- 230000001394 metastastic effect Effects 0.000 description 3
- 206010061289 metastatic neoplasm Diseases 0.000 description 3
- 230000005855 radiation Effects 0.000 description 3
- 229960005562 radium-223 Drugs 0.000 description 3
- 210000004872 soft tissue Anatomy 0.000 description 3
- CIOAGBVUUVVLOB-OUBTZVSYSA-N strontium-89 Chemical compound [89Sr] CIOAGBVUUVVLOB-OUBTZVSYSA-N 0.000 description 3
- 231100000419 toxicity Toxicity 0.000 description 3
- 230000001988 toxicity Effects 0.000 description 3
- 239000002699 waste material Substances 0.000 description 3
- 206010051779 Bone marrow toxicity Diseases 0.000 description 2
- 206010027452 Metastases to bone Diseases 0.000 description 2
- 231100000366 bone marrow toxicity Toxicity 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 230000001627 detrimental effect Effects 0.000 description 2
- 239000003937 drug carrier Substances 0.000 description 2
- 230000001678 irradiating effect Effects 0.000 description 2
- 231100000682 maximum tolerated dose Toxicity 0.000 description 2
- 150000002739 metals Chemical class 0.000 description 2
- 210000002307 prostate Anatomy 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 239000010453 quartz Substances 0.000 description 2
- 238000011362 radionuclide therapy Methods 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 229940075630 samarium oxide Drugs 0.000 description 2
- 229910001954 samarium oxide Inorganic materials 0.000 description 2
- FKTOIHSPIPYAPE-UHFFFAOYSA-N samarium(iii) oxide Chemical compound [O-2].[O-2].[O-2].[Sm+3].[Sm+3] FKTOIHSPIPYAPE-UHFFFAOYSA-N 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N silicon dioxide Inorganic materials O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 210000002700 urine Anatomy 0.000 description 2
- QBPPRVHXOZRESW-UHFFFAOYSA-N 1,4,7,10-tetraazacyclododecane Chemical group C1CNCCNCCNCCN1 QBPPRVHXOZRESW-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 241000282414 Homo sapiens Species 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- QPCDCPDFJACHGM-UHFFFAOYSA-N N,N-bis{2-[bis(carboxymethyl)amino]ethyl}glycine Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(=O)O)CCN(CC(O)=O)CC(O)=O QPCDCPDFJACHGM-UHFFFAOYSA-N 0.000 description 1
- 208000035977 Rare disease Diseases 0.000 description 1
- 208000032383 Soft tissue cancer Diseases 0.000 description 1
- WDLRUFUQRNWCPK-UHFFFAOYSA-N Tetraxetan Chemical compound OC(=O)CN1CCN(CC(O)=O)CCN(CC(O)=O)CCN(CC(O)=O)CC1 WDLRUFUQRNWCPK-UHFFFAOYSA-N 0.000 description 1
- JSTADIGKFYFAIY-GJNDDOAHSA-K [2-[bis[[hydroxy(oxido)phosphoryl]methyl]amino]ethyl-(phosphonomethyl)amino]methyl-hydroxyphosphinate;samarium-153(3+) Chemical compound [H+].[H+].[H+].[H+].[H+].[153Sm+3].[O-]P([O-])(=O)CN(CP([O-])([O-])=O)CCN(CP([O-])([O-])=O)CP([O-])([O-])=O JSTADIGKFYFAIY-GJNDDOAHSA-K 0.000 description 1
- 238000002679 ablation Methods 0.000 description 1
- 230000001174 ascending effect Effects 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 210000002449 bone cell Anatomy 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 150000003841 chloride salts Chemical class 0.000 description 1
- 239000013065 commercial product Substances 0.000 description 1
- 239000012141 concentrate Substances 0.000 description 1
- 238000011347 external beam therapy Methods 0.000 description 1
- 238000001730 gamma-ray spectroscopy Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000005372 isotope separation Methods 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 239000004081 narcotic agent Substances 0.000 description 1
- 210000000440 neutrophil Anatomy 0.000 description 1
- 238000009206 nuclear medicine Methods 0.000 description 1
- 201000008968 osteosarcoma Diseases 0.000 description 1
- 238000011349 peptide receptor radionuclide therapy Methods 0.000 description 1
- 102000014187 peptide receptors Human genes 0.000 description 1
- 108010011903 peptide receptors Proteins 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- HCWPIIXVSYCSAN-OIOBTWANSA-N radium-223 Chemical compound [223Ra] HCWPIIXVSYCSAN-OIOBTWANSA-N 0.000 description 1
- 102000005962 receptors Human genes 0.000 description 1
- 108020003175 receptors Proteins 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000007858 starting material Substances 0.000 description 1
- 210000001562 sternum Anatomy 0.000 description 1
- 229940006509 strontium-89 Drugs 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 230000007306 turnover Effects 0.000 description 1
- 238000011144 upstream manufacturing Methods 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
- A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
- A61K51/04—Organic compounds
- A61K51/0474—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group
- A61K51/0482—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group chelates from cyclic ligands, e.g. DOTA
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
- A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
- A61K51/04—Organic compounds
- A61K51/0474—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group
- A61K51/0478—Organic compounds complexes or complex-forming compounds, i.e. wherein a radioactive metal (e.g. 111In3+) is complexed or chelated by, e.g. a N2S2, N3S, NS3, N4 chelating group complexes from non-cyclic ligands, e.g. EDTA, MAG3
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- G—PHYSICS
- G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
- G21G—CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES
- G21G1/00—Arrangements for converting chemical elements by electromagnetic radiation, corpuscular radiation or particle bombardment, e.g. producing radioactive isotopes
- G21G1/02—Arrangements for converting chemical elements by electromagnetic radiation, corpuscular radiation or particle bombardment, e.g. producing radioactive isotopes in nuclear reactors
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Optics & Photonics (AREA)
- Physics & Mathematics (AREA)
- Engineering & Computer Science (AREA)
- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pain & Pain Management (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Oncology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762456191P | 2017-02-08 | 2017-02-08 | |
| US62/456,191 | 2017-02-08 | ||
| PCT/US2018/017082 WO2018148209A1 (en) | 2017-02-08 | 2018-02-06 | Method of use for therapeutic bone agents |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA3052973A1 CA3052973A1 (en) | 2018-08-16 |
| CA3052973C true CA3052973C (en) | 2024-02-06 |
Family
ID=63107036
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA3052973A Active CA3052973C (en) | 2017-02-08 | 2018-02-06 | Method of use for therapeutic bone agents |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US11813339B2 (enExample) |
| EP (1) | EP3579886A4 (enExample) |
| JP (3) | JP7792746B2 (enExample) |
| CA (1) | CA3052973C (enExample) |
| WO (1) | WO2018148209A1 (enExample) |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5059412A (en) * | 1984-06-04 | 1991-10-22 | The Dow Chemical Company | Macrocyclic aminophosphonic acid complexes for the treatment of calcific tumors |
| EP1475105A1 (en) | 2003-05-09 | 2004-11-10 | Schering AG | Bone localising radiopharmaceutical and tubulin-interacting compound combinatorial radiotherapy |
| WO2011149844A1 (en) * | 2010-05-24 | 2011-12-01 | Iso Therapeutics Group Llc | Delivery of high dose therapeutic radioisotopes to bone |
| CN105792836A (zh) * | 2013-08-28 | 2016-07-20 | 施特姆森特克斯股份有限公司 | 新型sez6调节剂以及应用方法 |
| ES2949277T3 (es) * | 2013-10-07 | 2023-09-27 | Igl Pharma Inc | Proceso de preparación de agentes óseos terapéuticos de alta pureza |
| JP6930922B2 (ja) | 2015-05-25 | 2021-09-01 | アイジーエル ファーマ，インコーポレイティド | 放射性同位体用ｄｏｔｍｐキット製剤 |
-
2018
- 2018-02-06 EP EP18751017.7A patent/EP3579886A4/en active Pending
- 2018-02-06 JP JP2019563340A patent/JP7792746B2/ja active Active
- 2018-02-06 CA CA3052973A patent/CA3052973C/en active Active
- 2018-02-06 US US16/484,706 patent/US11813339B2/en active Active
- 2018-02-06 WO PCT/US2018/017082 patent/WO2018148209A1/en not_active Ceased
-
2022
- 2022-10-13 JP JP2022164581A patent/JP2022183238A/ja active Pending
-
2024
- 2024-12-02 JP JP2024209612A patent/JP2025036436A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| CA3052973A1 (en) | 2018-08-16 |
| JP2020506239A (ja) | 2020-02-27 |
| JP7792746B2 (ja) | 2025-12-26 |
| JP2022183238A (ja) | 2022-12-08 |
| US20210138095A1 (en) | 2021-05-13 |
| US11813339B2 (en) | 2023-11-14 |
| WO2018148209A1 (en) | 2018-08-16 |
| EP3579886A4 (en) | 2020-11-25 |
| JP2025036436A (ja) | 2025-03-14 |
| EP3579886A1 (en) | 2019-12-18 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| KR100671387B1 (ko) | 석회화된 조직을 표적으로 하는, 통증 완화, 뼈 암 치료,및 뼈 표면 조절용 라듐-223의 제조 및 용도 | |
| CA2413736C (en) | Thorium or actinium radionuclides for endoradionuclide therapy | |
| Lin et al. | Effect of reaction conditions on preparations of rhenium-188 hydroxyethylidene diphosphonate complexes | |
| US10596277B2 (en) | High purity therapeutic bone agents | |
| CA3052973C (en) | Method of use for therapeutic bone agents | |
| Toegel et al. | In vitro evaluation of no carrier added, carrier added and cross-complexed [90Y]-EDTMP provides evidence for a novel “foreign carrier theory” | |
| HK1090750B (en) | Methods of preparing radium-223, and pharmaceutically acceptable agents and reagent set |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20220216 |
|
| EEER | Examination request |
Effective date: 20220216 |
|
| EEER | Examination request |
Effective date: 20220216 |
|
| EEER | Examination request |
Effective date: 20220216 |
|
| EEER | Examination request |
Effective date: 20220216 |
|
| EEER | Examination request |
Effective date: 20220216 |
|
| EEER | Examination request |
Effective date: 20220216 |