NO332441B1 - Sammensetning av Taxotere® og flavopiridol - Google Patents
Sammensetning av Taxotere® og flavopiridol Download PDFInfo
- Publication number
- NO332441B1 NO332441B1 NO20034124A NO20034124A NO332441B1 NO 332441 B1 NO332441 B1 NO 332441B1 NO 20034124 A NO20034124 A NO 20034124A NO 20034124 A NO20034124 A NO 20034124A NO 332441 B1 NO332441 B1 NO 332441B1
- Authority
- NO
- Norway
- Prior art keywords
- taxotere
- flavopiridol
- days
- tumor
- dose
- Prior art date
Links
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical group O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 title claims abstract description 39
- 229940063683 taxotere Drugs 0.000 title claims abstract description 29
- BIIVYFLTOXDAOV-YVEFUNNKSA-N alvocidib Chemical compound O[C@@H]1CN(C)CC[C@@H]1C1=C(O)C=C(O)C2=C1OC(C=1C(=CC=CC=1)Cl)=CC2=O BIIVYFLTOXDAOV-YVEFUNNKSA-N 0.000 title claims description 26
- 229950010817 alvocidib Drugs 0.000 title claims description 25
- 239000000203 mixture Substances 0.000 title claims description 15
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 7
- 238000011282 treatment Methods 0.000 claims description 10
- 201000010099 disease Diseases 0.000 claims description 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 6
- 230000001225 therapeutic effect Effects 0.000 claims description 6
- 206010006187 Breast cancer Diseases 0.000 claims description 5
- 208000026310 Breast neoplasm Diseases 0.000 claims description 5
- 230000001613 neoplastic effect Effects 0.000 claims description 5
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims description 2
- 208000020816 lung neoplasm Diseases 0.000 claims description 2
- 201000005202 lung cancer Diseases 0.000 claims 1
- 102000003903 Cyclin-dependent kinases Human genes 0.000 abstract description 7
- 108090000266 Cyclin-dependent kinases Proteins 0.000 abstract description 7
- 229940123237 Taxane Drugs 0.000 abstract description 4
- DKPFODGZWDEEBT-QFIAKTPHSA-N taxane Chemical class C([C@]1(C)CCC[C@@H](C)[C@H]1C1)C[C@H]2[C@H](C)CC[C@@H]1C2(C)C DKPFODGZWDEEBT-QFIAKTPHSA-N 0.000 abstract 1
- 206010028980 Neoplasm Diseases 0.000 description 29
- 229930012538 Paclitaxel Natural products 0.000 description 12
- 230000030833 cell death Effects 0.000 description 12
- 229960001592 paclitaxel Drugs 0.000 description 12
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 description 12
- 241001465754 Metazoa Species 0.000 description 11
- 229960003668 docetaxel Drugs 0.000 description 11
- 241000699670 Mus sp. Species 0.000 description 10
- 230000004044 response Effects 0.000 description 9
- 108091007914 CDKs Proteins 0.000 description 7
- 230000022131 cell cycle Effects 0.000 description 6
- 239000003795 chemical substances by application Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 231100000252 nontoxic Toxicity 0.000 description 5
- 230000003000 nontoxic effect Effects 0.000 description 5
- 230000000259 anti-tumor effect Effects 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 4
- 230000007246 mechanism Effects 0.000 description 4
- 102100033350 ATP-dependent translocase ABCB1 Human genes 0.000 description 3
- 108090000704 Tubulin Proteins 0.000 description 3
- 239000002246 antineoplastic agent Substances 0.000 description 3
- 230000037396 body weight Effects 0.000 description 3
- 230000034994 death Effects 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 230000002401 inhibitory effect Effects 0.000 description 3
- 230000036457 multidrug resistance Effects 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 102000016736 Cyclin Human genes 0.000 description 2
- 108050006400 Cyclin Proteins 0.000 description 2
- 206010059866 Drug resistance Diseases 0.000 description 2
- 230000010190 G1 phase Effects 0.000 description 2
- 102000015696 Interleukins Human genes 0.000 description 2
- 108010063738 Interleukins Proteins 0.000 description 2
- 241000202349 Taxus brevifolia Species 0.000 description 2
- 102000004243 Tubulin Human genes 0.000 description 2
- 229940041181 antineoplastic drug Drugs 0.000 description 2
- 201000008274 breast adenocarcinoma Diseases 0.000 description 2
- 201000011510 cancer Diseases 0.000 description 2
- 238000002512 chemotherapy Methods 0.000 description 2
- 208000029742 colonic neoplasm Diseases 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 239000003102 growth factor Substances 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 229940047122 interleukins Drugs 0.000 description 2
- 238000001990 intravenous administration Methods 0.000 description 2
- 208000032839 leukemia Diseases 0.000 description 2
- 231100000682 maximum tolerated dose Toxicity 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000004083 survival effect Effects 0.000 description 2
- 230000004614 tumor growth Effects 0.000 description 2
- 102100025573 1-alkyl-2-acetylglycerophosphocholine esterase Human genes 0.000 description 1
- 108010024976 Asparaginase Proteins 0.000 description 1
- 206010009944 Colon cancer Diseases 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 208000000461 Esophageal Neoplasms Diseases 0.000 description 1
- 230000010337 G2 phase Effects 0.000 description 1
- 108010017080 Granulocyte Colony-Stimulating Factor Proteins 0.000 description 1
- 102000004269 Granulocyte Colony-Stimulating Factor Human genes 0.000 description 1
- 102000004457 Granulocyte-Macrophage Colony-Stimulating Factor Human genes 0.000 description 1
- 108010017213 Granulocyte-Macrophage Colony-Stimulating Factor Proteins 0.000 description 1
- 208000012766 Growth delay Diseases 0.000 description 1
- 102000014150 Interferons Human genes 0.000 description 1
- 108010050904 Interferons Proteins 0.000 description 1
- 208000008839 Kidney Neoplasms Diseases 0.000 description 1
- 230000027311 M phase Effects 0.000 description 1
- 108010047230 Member 1 Subfamily B ATP Binding Cassette Transporter Proteins 0.000 description 1
- 241001529936 Murinae Species 0.000 description 1
- 206010033128 Ovarian cancer Diseases 0.000 description 1
- 206010061535 Ovarian neoplasm Diseases 0.000 description 1
- 206010061902 Pancreatic neoplasm Diseases 0.000 description 1
- 108091000080 Phosphotransferase Proteins 0.000 description 1
- 102000001708 Protein Isoforms Human genes 0.000 description 1
- 108010029485 Protein Isoforms Proteins 0.000 description 1
- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 description 1
- 206010038389 Renal cancer Diseases 0.000 description 1
- 229940124639 Selective inhibitor Drugs 0.000 description 1
- GAMYVSCDDLXAQW-AOIWZFSPSA-N Thermopsosid Natural products O(C)c1c(O)ccc(C=2Oc3c(c(O)cc(O[C@H]4[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O4)c3)C(=O)C=2)c1 GAMYVSCDDLXAQW-AOIWZFSPSA-N 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 238000009098 adjuvant therapy Methods 0.000 description 1
- 238000011394 anticancer treatment Methods 0.000 description 1
- 230000006907 apoptotic process Effects 0.000 description 1
- 230000008512 biological response Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 201000008275 breast carcinoma Diseases 0.000 description 1
- 239000003560 cancer drug Substances 0.000 description 1
- 230000010261 cell growth Effects 0.000 description 1
- 230000035572 chemosensitivity Effects 0.000 description 1
- 210000001072 colon Anatomy 0.000 description 1
- 229940043378 cyclin-dependent kinase inhibitor Drugs 0.000 description 1
- 229940127089 cytotoxic agent Drugs 0.000 description 1
- 230000002354 daily effect Effects 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 229930004069 diterpene Natural products 0.000 description 1
- -1 diterpene compounds Chemical class 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000009509 drug development Methods 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 229930003944 flavone Natural products 0.000 description 1
- 150000002212 flavone derivatives Chemical class 0.000 description 1
- 235000011949 flavones Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 235000006539 genistein Nutrition 0.000 description 1
- 229940045109 genistein Drugs 0.000 description 1
- TZBJGXHYKVUXJN-UHFFFAOYSA-N genistein Natural products C1=CC(O)=CC=C1C1=COC2=CC(O)=CC(O)=C2C1=O TZBJGXHYKVUXJN-UHFFFAOYSA-N 0.000 description 1
- ZCOLJUOHXJRHDI-CMWLGVBASA-N genistein 7-O-beta-D-glucoside Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=CC(O)=C2C(=O)C(C=3C=CC(O)=CC=3)=COC2=C1 ZCOLJUOHXJRHDI-CMWLGVBASA-N 0.000 description 1
- 230000003394 haemopoietic effect Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 229940047124 interferons Drugs 0.000 description 1
- 201000010982 kidney cancer Diseases 0.000 description 1
- 230000002147 killing effect Effects 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 201000005296 lung carcinoma Diseases 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 201000001441 melanoma Diseases 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000025090 microtubule depolymerization Effects 0.000 description 1
- 230000011278 mitosis Effects 0.000 description 1
- 230000035772 mutation Effects 0.000 description 1
- 238000009099 neoadjuvant therapy Methods 0.000 description 1
- 102000020233 phosphotransferase Human genes 0.000 description 1
- 230000004983 pleiotropic effect Effects 0.000 description 1
- 230000003389 potentiating effect Effects 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 235000005875 quercetin Nutrition 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 210000004881 tumor cell Anatomy 0.000 description 1
- VHBFFQKBGNRLFZ-UHFFFAOYSA-N vitamin p Natural products O1C2=CC=CC=C2C(=O)C=C1C1=CC=CC=C1 VHBFFQKBGNRLFZ-UHFFFAOYSA-N 0.000 description 1
- 230000004580 weight loss Effects 0.000 description 1
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
- A61K31/435—Heterocyclic 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/453—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with oxygen as a ring hetero atom
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US27794801P | 2001-03-23 | 2001-03-23 | |
| US30269201P | 2001-07-05 | 2001-07-05 | |
| US33491601P | 2001-12-04 | 2001-12-04 | |
| PCT/EP2002/004083 WO2002076484A2 (en) | 2001-03-23 | 2002-03-22 | Combination of a taxane and a cyclin-dependent kinase inhibitor |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| NO20034124L NO20034124L (no) | 2003-09-16 |
| NO20034124D0 NO20034124D0 (no) | 2003-09-16 |
| NO332441B1 true NO332441B1 (no) | 2012-09-17 |
Family
ID=27402954
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO20034124A NO332441B1 (no) | 2001-03-23 | 2003-09-16 | Sammensetning av Taxotere® og flavopiridol |
Country Status (33)
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2003217982A1 (en) * | 2002-03-06 | 2003-09-22 | The Medical Research And Education Trust | Botanical extract compositions with anti-cancer or phytoestrogenic activity comprising wogonin, isoliquiritigenin and/or coumestrol |
| AU2003287081A1 (en) * | 2002-10-16 | 2004-05-04 | Ilex Products, Inc. | Clofarabine and taxane chemotherapy combination |
| EP1558242B1 (en) * | 2002-11-06 | 2008-12-24 | Cyclacel Limited | Combination comprising docetaxel and a cdk inhibitor |
| ES2390237T3 (es) * | 2006-02-10 | 2012-11-07 | Nerviano Medical Sciences S.R.L. | Combinaciones que comprenden un inhibidor de cdk y un anticuerpo anti-factor de crecimiento o un agente antimitótico |
| BR112013012313A2 (pt) * | 2010-11-19 | 2019-09-24 | Piramal Enterprises Limited | combinação farmacêutica de paclitaxel e um inibidor de cdk |
| ME03589B (me) | 2011-04-01 | 2020-07-20 | Astrazeneca Ab | Terapeutski tretman |
| MX367640B (es) | 2011-11-30 | 2019-08-29 | Astrazeneca Ab | Tratamiento combinado del cáncer. |
| AU2013204533B2 (en) | 2012-04-17 | 2017-02-02 | Astrazeneca Ab | Crystalline forms |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2601675B1 (fr) * | 1986-07-17 | 1988-09-23 | Rhone Poulenc Sante | Derives du taxol, leur preparation et les compositions pharmaceutiques qui les contiennent |
| MX9102128A (es) * | 1990-11-23 | 1992-07-08 | Rhone Poulenc Rorer Sa | Derivados de taxano,procedimiento para su preparacion y composicion farmaceutica que los contiene |
| FR2697752B1 (fr) * | 1992-11-10 | 1995-04-14 | Rhone Poulenc Rorer Sa | Compositions antitumorales contenant des dérivés du taxane. |
| EP0888458A4 (en) * | 1996-02-20 | 2004-05-06 | Sloan Kettering Institutefor C | COMBINATION OF PKC INHIBITORS AND THERAPEUTIC AGENTS FOR TREATING CANCER |
-
2002
- 2002-03-21 UY UY27220A patent/UY27220A1/es not_active Application Discontinuation
- 2002-03-21 US US10/101,947 patent/US20020182204A1/en not_active Abandoned
- 2002-03-22 AU AU2002312815A patent/AU2002312815B2/en not_active Ceased
- 2002-03-22 TW TW091105567A patent/TWI355935B/zh not_active IP Right Cessation
- 2002-03-22 ES ES02737950T patent/ES2305253T3/es not_active Expired - Lifetime
- 2002-03-22 SI SI200230711T patent/SI1372652T1/sl unknown
- 2002-03-22 CN CNA028070380A patent/CN1498107A/zh active Pending
- 2002-03-22 IL IL15805802A patent/IL158058A0/xx unknown
- 2002-03-22 KR KR1020037012338A patent/KR100879712B1/ko not_active Expired - Fee Related
- 2002-03-22 SK SK1169-2003A patent/SK287481B6/sk not_active IP Right Cessation
- 2002-03-22 AR ARP020101061A patent/AR034222A1/es unknown
- 2002-03-22 BR BR0208221-7A patent/BR0208221A/pt not_active Application Discontinuation
- 2002-03-22 PE PE2002000230A patent/PE20020907A1/es not_active Application Discontinuation
- 2002-03-22 NZ NZ527655A patent/NZ527655A/xx not_active IP Right Cessation
- 2002-03-22 AT AT02737950T patent/ATE395917T1/de active
- 2002-03-22 EP EP02737950A patent/EP1372652B1/en not_active Expired - Lifetime
- 2002-03-22 CA CA002441441A patent/CA2441441C/en not_active Expired - Fee Related
- 2002-03-22 PT PT02737950T patent/PT1372652E/pt unknown
- 2002-03-22 HR HR20030766A patent/HRPK20030766B3/xx not_active IP Right Cessation
- 2002-03-22 DE DE60226710T patent/DE60226710D1/de not_active Expired - Lifetime
- 2002-03-22 PL PL367702A patent/PL206118B1/pl not_active IP Right Cessation
- 2002-03-22 MX MXPA03007743A patent/MXPA03007743A/es active IP Right Grant
- 2002-03-22 JP JP2002574997A patent/JP2004521140A/ja active Pending
- 2002-03-22 ME MEP-164/08A patent/MEP16408A/xx unknown
- 2002-03-22 RS YUP-695/03A patent/RS50681B/sr unknown
- 2002-03-22 CZ CZ20032551A patent/CZ301423B6/cs not_active IP Right Cessation
- 2002-03-22 WO PCT/EP2002/004083 patent/WO2002076484A2/en not_active Ceased
- 2002-03-22 DK DK02737950T patent/DK1372652T3/da active
- 2002-03-22 EA EA200301053A patent/EA007815B1/ru not_active IP Right Cessation
- 2002-03-22 HU HU0303589A patent/HU229258B1/hu not_active IP Right Cessation
-
2003
- 2003-09-16 NO NO20034124A patent/NO332441B1/no not_active IP Right Cessation
- 2003-09-22 ZA ZA2003/07381A patent/ZA200307381B/en unknown
- 2003-09-22 IL IL158058A patent/IL158058A/en not_active IP Right Cessation
-
2006
- 2006-01-27 US US11/341,840 patent/US20060128640A1/en not_active Abandoned
-
2008
- 2008-08-11 CY CY20081100843T patent/CY1110449T1/el unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |