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Volumn 27, Issue 3, 2017, Pages 121-129

The Effects of 2′-O-Methoxyethyl Containing Antisense Oligonucleotides on Platelets in Human Clinical Trials

Author keywords

Antisense; factor XI; Platelets; Safety; Thrombocytopenia

Indexed keywords

BLOOD CLOTTING FACTOR 11; MIPOMERSEN; PLACEBO; ANTISENSE OLIGONUCLEOTIDE; NUCLEOTIDE;

EID: 85020173493     PISSN: 21593337     EISSN: 21593345     Source Type: Journal    
DOI: 10.1089/nat.2016.0650     Document Type: Article
Times cited : (108)

References (34)
  • 1
    • 84925283858 scopus 로고    scopus 로고
    • CD49d antisense drug ATL1102 reduces disease activity in patients with relapsingremitting MS
    • ATL1102 Study Group
    • Limmroth V, F Barkhof, N Desem, MP Diamond, G Tachas and ATL1102 Study Group. (2014). CD49d antisense drug ATL1102 reduces disease activity in patients with relapsingremitting MS. Neurology 83:1780-1788.
    • (2014) Neurology , vol.83 , pp. 1780-1788
    • Limmroth, V.1    Barkhof, F.2    Desem, N.3    Diamond, M.P.4    Tachas, G.5
  • 2
    • 84980407562 scopus 로고    scopus 로고
    • Integrated safety assessment of 2-O-methoxyethyl chimeric antisense oligonucleotides in non-human primates and healthy human volunteers
    • Crooke ST, BF Baker, TJ Kwoh, W Cheng, DJ Schulz, S Xia, N Salgado, HH Bui, CE Hart, et al. (2016). Integrated safety assessment of 2-O-methoxyethyl chimeric antisense oligonucleotides in non-human primates and healthy human volunteers. Mol Ther 24:1771-1782.
    • (2016) Mol Ther , vol.24 , pp. 1771-1782
    • Crooke, S.T.1    Baker, B.F.2    Kwoh, T.J.3    Cheng, W.4    Schulz, D.J.5    Xia, S.6    Salgado, N.7    Bui, H.H.8    Hart, C.E.9
  • 3
    • 84857913871 scopus 로고    scopus 로고
    • Phase I/II trial of custirsen (OGX-011), an inhibitor of clusterin, in combination with a gemcitabine and platinum regimen in patients with previously untreated advanced non-small cell lung cancer
    • Laskin JJ, G Nicholas, C Lee, B Gitlitz, M Vincent, Y Cormier, J Stephenson, Y Ung, R Sanborn, et al. (2012). Phase I/II trial of custirsen (OGX-011), an inhibitor of clusterin, in combination with a gemcitabine and platinum regimen in patients with previously untreated advanced non-small cell lung cancer. J Thorac Oncol 7: 579-586.
    • (2012) J Thorac Oncol , vol.7 , pp. 579-586
    • Laskin, J.J.1    Nicholas, G.2    Lee, C.3    Gitlitz, B.4    Vincent, M.5    Cormier, Y.6    Stephenson, J.7    Ung, Y.8    Sanborn, R.9
  • 4
    • 80052468423 scopus 로고    scopus 로고
    • Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after firstline docetaxel: CUOG trial P-06c
    • Canadian Uro-Oncology Group
    • Saad F, S Hotte, S North, B Eigl, K Chi, P Czaykowski, L Wood, M Pollak, S Berry, et al.; Canadian Uro-Oncology Group. (2011). Randomized phase II trial of Custirsen (OGX-011) in combination with docetaxel or mitoxantrone as second-line therapy in patients with metastatic castrate-resistant prostate cancer progressing after firstline docetaxel: CUOG trial P-06c. Clin Cancer Res 17: 5765-5773.
    • (2011) Clin Cancer Res , vol.17 , pp. 5765-5773
    • Saad, F.1    Hotte, S.2    North, S.3    Eigl, B.4    Chi, K.5    Czaykowski, P.6    Wood, L.7    Pollak, M.8    Berry, S.9
  • 7
    • 84923138992 scopus 로고    scopus 로고
    • Evaluation of antitumor activity using change in tumor size of the survivin antisense oligonucleotide LY2181308 in combination with docetaxel for second-line treatment of patients with non-small-cell lung cancer: A randomized open-label phase II study
    • Natale R, F Blackhall, D Kowalski, R Ramlau, G Bepler, F Grossi, C Lerchenmüller, M Pinder-Schenck, J Mezger, et al. (2014). Evaluation of antitumor activity using change in tumor size of the survivin antisense oligonucleotide LY2181308 in combination with docetaxel for second-line treatment of patients with non-small-cell lung cancer: a randomized open-label phase II study. J Thorac Oncol 9:1704-1708.
    • (2014) J Thorac Oncol , vol.9 , pp. 1704-1708
    • Natale, R.1    Blackhall, F.2    Kowalski, D.3    Ramlau, R.4    Bepler, G.5    Grossi, F.6    Lerchenmüller, C.7    Pinder-Schenck, M.8    Mezger, J.9
  • 8
    • 84895060456 scopus 로고    scopus 로고
    • A randomised phase 2 study combining LY2181308 sodium (survivin antisense oligonucleotide) with first-line docetaxel/prednisone in patients with castration-resistant prostate cancer
    • Wiechno P, BG Somer, B Mellado, PL Ch?osta, JM Cervera Grau, D Castellano, C Reuter, M Stöckle, J Kamradt, et al. (2014). A randomised phase 2 study combining LY2181308 sodium (survivin antisense oligonucleotide) with first-line docetaxel/prednisone in patients with castration-resistant prostate cancer. Eur Urol 65:516-520.
    • (2014) Eur Urol , vol.65 , pp. 516-520
    • Wiechno, P.1    Somer, B.G.2    Mellado, B.3    Chosta, P.L.4    Cervera Grau, J.M.5    Castellano, D.6    Reuter, C.7    Stöckle, M.8    Kamradt, J.9
  • 9
    • 80054114844 scopus 로고    scopus 로고
    • A phase 1 dose escalation, pharmacokinetic, and pharmacodynamic evaluation of eIF-4E antisense oligonucleotide LY2275796 in patients with advanced cancer
    • Hong DS, R Kurzrock, Y Oh, J Wheler, A Naing, L Brail, S Callies, V Andre, SK Kadam, et al. (2011). A phase 1 dose escalation, pharmacokinetic, and pharmacodynamic evaluation of eIF-4E antisense oligonucleotide LY2275796 in patients with advanced cancer. Clin Cancer Res 17:6582-6591.
    • (2011) Clin Cancer Res , vol.17 , pp. 6582-6591
    • Hong, D.S.1    Kurzrock, R.2    Oh, Y.3    Wheler, J.4    Naing, A.5    Brail, L.6    Callies, S.7    Andre, V.8    Kadam, S.K.9
  • 12
    • 0032170976 scopus 로고    scopus 로고
    • Phosphorothioate oligonucleotides inhibit the intrinsic tenase complex
    • Sheehan JP and HC Lan. (1998). Phosphorothioate oligonucleotides inhibit the intrinsic tenase complex. Blood 92:1617-1625.
    • (1998) Blood , vol.92 , pp. 1617-1625
    • Sheehan, J.P.1    Lan, H.C.2
  • 13
    • 0035942332 scopus 로고    scopus 로고
    • Phosphorothioate oligonucleotides inhibit the intrinsic tenase complex by an allosteric mechanism
    • Sheehan JP and TM Phan. (2001). Phosphorothioate oligonucleotides inhibit the intrinsic tenase complex by an allosteric mechanism. Biochemistry 40:4980-4989.
    • (2001) Biochemistry , vol.40 , pp. 4980-4989
    • Sheehan, J.P.1    Phan, T.M.2
  • 14
    • 84863259511 scopus 로고    scopus 로고
    • An overview of the clinical safety experience of first-and second generation antisense oligonucleotides
    • 2nd edition. Crooke ST, ed. CRC Press, New York
    • Kwoh TJ. (2007). An overview of the clinical safety experience of first-and second generation antisense oligonucleotides. In: Antisense Drug Technology Principles, Strategies, and Applications, 2nd edition. Crooke ST, ed. CRC Press, New York, pp. 365-399.
    • (2007) Antisense Drug Technology Principles, Strategies, and Applications , pp. 365-399
    • Kwoh, T.J.1
  • 16
    • 0036896204 scopus 로고    scopus 로고
    • Phase i trial of ISIS 104838, a 2-methoxyethyl modified antisense oligonucleotide targeting tumor necrosis factor-alpha
    • Sewell KL, RS Geary, BF Baker, JM Glover, TG Mant, RZ Yu, JA Tami and FA Dorr. (2002). Phase I trial of ISIS 104838, a 2-methoxyethyl modified antisense oligonucleotide targeting tumor necrosis factor-alpha. J Pharmacol Exp Ther 303:1334-1343.
    • (2002) J Pharmacol Exp Ther , vol.303 , pp. 1334-1343
    • Sewell, K.L.1    Geary, R.S.2    Baker, B.F.3    Glover, J.M.4    Mant, T.G.5    Yu, R.Z.6    Tami, J.A.7    Dorr, F.A.8
  • 19
    • 84863229481 scopus 로고    scopus 로고
    • Antisense inhibition of coagulation factor XI prolongs APTT without increased bleeding risk in cynomolgus monkeys
    • Younis HS, J Crosby, JI Huh, HS Lee, S Rime, B Monia and SP Henry. (2012). Antisense inhibition of coagulation factor XI prolongs APTT without increased bleeding risk in cynomolgus monkeys. Blood 119:2401-2408.
    • (2012) Blood , vol.119 , pp. 2401-2408
    • Younis, H.S.1    Crosby, J.2    Huh, J.I.3    Lee, H.S.4    Rime, S.5    Monia, B.6    Henry, S.P.7
  • 20
    • 78649471947 scopus 로고    scopus 로고
    • Inhibition of the intrinsic coagulation pathway factor XI by antisense oligonucleotides: A novel antithrombotic strategy with lowered bleeding risk
    • Zhang H, EC Löwenberg, JR Crosby, AR MacLeod, C Zhao, D Gao, C Black, AS Revenko, JC Meijers, et al. (2010). Inhibition of the intrinsic coagulation pathway factor XI by antisense oligonucleotides: a novel antithrombotic strategy with lowered bleeding risk. Blood 116: 4684-4692.
    • (2010) Blood , vol.116 , pp. 4684-4692
    • Zhang, H.1    Löwenberg, E.C.2    Crosby, J.R.3    MacLeod, A.R.4    Zhao, C.5    Gao, D.6    Black, C.7    Revenko, A.S.8    Meijers, J.C.9
  • 21
    • 57449103966 scopus 로고    scopus 로고
    • Lack of pharmacokinetic interaction of mipomersen sodium (ISIS 301012), a 2-Omethoxyethyl modified antisense oligonucleotide targeting apolipoprotein B-100 messenger RNA, with simvastatin and ezetimibe
    • Yu RZ, RS Geary, JD Flaim, GC Riley, DL Tribble, AA vanVliet and MK Wedel. (2009). Lack of pharmacokinetic interaction of mipomersen sodium (ISIS 301012), a 2-Omethoxyethyl modified antisense oligonucleotide targeting apolipoprotein B-100 messenger RNA, with simvastatin and ezetimibe. Clin Pharmacokinet 48:39-50.
    • (2009) Clin Pharmacokinet , vol.48 , pp. 39-50
    • Yu, R.Z.1    Geary, R.S.2    Flaim, J.D.3    Riley, G.C.4    Tribble, D.L.5    VanVliet, A.A.6    Wedel, M.K.7
  • 22
    • 84994607113 scopus 로고    scopus 로고
    • Antisense oligonucleotides targeting apolipoprotein( a) in people with raised lipoprotein(a): Two randomized, double-blind, placebo-controlled, dose-ranging trials
    • Viney NJ, JC van Capelleveen, RS Geary, S Xia, JA Tami, RZ Yu, SM Marcovina, SG Hughes, MJ Graham, et al. (2016). Antisense oligonucleotides targeting apolipoprotein( a) in people with raised lipoprotein(a): two randomized, double-blind, placebo-controlled, dose-ranging trials. Lancet 388:2239-2253.
    • (2016) Lancet , vol.388 , pp. 2239-2253
    • Viney, N.J.1    Van Capelleveen, J.C.2    Geary, R.S.3    Xia, S.4    Tami, J.A.5    Yu, R.Z.6    Marcovina, S.M.7    Hughes, S.G.8    Graham, M.J.9
  • 24
    • 84978529098 scopus 로고    scopus 로고
    • Long-term mipomersen treatment is associated with a reduction in cardiovascular events in patients with familial hypercholesterolemia
    • Duell PB, RD Santos, B-A Kirwan, JL Witztum, S Tsimikas and JJP Kastelein. (2016). Long-term mipomersen treatment is associated with a reduction in cardiovascular events in patients with familial hypercholesterolemia. J Clin Lipidol 10:1011-1021.
    • (2016) J Clin Lipidol , vol.10 , pp. 1011-1021
    • Duell, P.B.1    Santos, R.D.2    Kirwan, B.-A.3    Witztum, J.L.4    Tsimikas, S.5    Kastelein, J.J.P.6
  • 26
    • 84924415690 scopus 로고    scopus 로고
    • Long-term efficacy and safety of mipomersen in patients with familial hypercholesterolaemia: 2-year interim results of an open-label extension
    • Santos RD, PB Duell, C East, JR Guyton, PM Moriarty, W Chin and RS Mittleman. (2015). Long-term efficacy and safety of mipomersen in patients with familial hypercholesterolaemia: 2-year interim results of an open-label extension. Eur Heart J 36:566-575.
    • (2015) Eur Heart J , vol.36 , pp. 566-575
    • Santos, R.D.1    Duell, P.B.2    East, C.3    Guyton, J.R.4    Moriarty, P.M.5    Chin, W.6    Mittleman, R.S.7
  • 29
    • 77949485460 scopus 로고    scopus 로고
    • Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: A randomised, double-blind, placebo-controlled trial
    • Raal FJ, RD Santos, DJ Blom, AD Marais, MJ Charng, WC Cromwell, RH Lachmann, D Gaudet, JL Tan, et al. (2010). Mipomersen, an apolipoprotein B synthesis inhibitor, for lowering of LDL cholesterol concentrations in patients with homozygous familial hypercholesterolaemia: a randomised, double-blind, placebo-controlled trial. Lancet 375:998-1006.
    • (2010) Lancet , vol.375 , pp. 998-1006
    • Raal, F.J.1    Santos, R.D.2    Blom, D.J.3    Marais, A.D.4    Charng, M.J.5    Cromwell, W.C.6    Lachmann, R.H.7    Gaudet, D.8    Tan, J.L.9
  • 31
    • 84991493162 scopus 로고    scopus 로고
    • Development of a quantitative BRET affinity assay for nucleic acid-protein interactions
    • Vickers TA and ST Crooke. (2016). Development of a quantitative BRET affinity assay for nucleic acid-protein interactions. PLoS One 11:e0161930.
    • (2016) PLoS One , vol.11 , pp. e0161930
    • Vickers, T.A.1    Crooke, S.T.2
  • 33
    • 85020176368 scopus 로고    scopus 로고
    • FDA Briefing Document, NDA 206031, (November 24,) (accessed on September 22, 2016)
    • FDA Briefing Document, NDA 206031. Drisapersen, Peripheral and Central Nervous System Drugs Advisory Committee Meeting (November 24, 2015), www. fda. gov/ downloads/advisorycommittees/committeesmeetingmaterials/ drugs/peripheralandcentralnervoussystemdrugsadvisory committee/ucm473737. pdf (accessed on September 22, 2016).
    • (2015) Drisapersen, Peripheral and Central Nervous System Drugs Advisory Committee Meeting
  • 34
    • 84887841103 scopus 로고    scopus 로고
    • First-in-human phase i study of EZN-4176, a locked nucleic acid antisense oligonucleotide to exon 4 of the androgen receptor mRNA in patients with castrationresistant prostate cancer
    • Bianchini D, A Omlin, C Pezaro, D Lorente, R Ferraldeschi, D Mukherji, M Crespo, I Figueiredo, S Miranda, et al. (2013). First-in-human phase I study of EZN-4176, a locked nucleic acid antisense oligonucleotide to exon 4 of the androgen receptor mRNA in patients with castrationresistant prostate cancer. Br J Cancer 109:2579-2586.
    • (2013) Br J Cancer , vol.109 , pp. 2579-2586
    • Bianchini, D.1    Omlin, A.2    Pezaro, C.3    Lorente, D.4    Ferraldeschi, R.5    Mukherji, D.6    Crespo, M.7    Figueiredo, I.8    Miranda, S.9


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.