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No effect on QT intervals of mipomersen, a 2'-O-methoxyethyl modified antisense oligonucleotide targeting ApoB-100 mRNA, in a phase I dose escalation placebo-controlled study, and confirmed by a thorough QT (tQT) study, in healthy subjects.
Yu RZ, Gunawan R, Li Z, Mittleman RS, Mahmood A, Grundy JS, Singleton W, Geary R, Wang Y. Yu RZ, et al. Among authors: gunawan r. Eur J Clin Pharmacol. 2016 Mar;72(3):267-75. doi: 10.1007/s00228-015-1992-y. Epub 2015 Dec 9. Eur J Clin Pharmacol. 2016. PMID: 26645588 Clinical Trial.
Lack of QT Prolongation for 2'-O-Methoxyethyl-Modified Antisense Oligonucleotides Based on Retrospective Exposure/Response Analysis of Ten Phase 1 Dose-Escalation Placebo-Controlled Studies in Healthy Subjects.
Yu RZ, Gunawan R, Geary RS, Hughes SG, Henry SP, Wang Y. Yu RZ, et al. Among authors: gunawan r. Nucleic Acid Ther. 2017 Oct;27(5):285-294. doi: 10.1089/nat.2017.0676. Epub 2017 Aug 11. Nucleic Acid Ther. 2017. PMID: 28799823 Free PMC article. Clinical Trial.
Comparative pharmacokinetics, safety, and tolerability of two sources of ch14.18 in pediatric patients with high-risk neuroblastoma following myeloablative therapy.
Marachelian A, Desai A, Balis F, Katzenstein H, Qayed M, Armstrong M, Neville KA, Cohn SL, Bush M, Gunawan R, Lim AP, Smith MA, Smith LM. Marachelian A, et al. Among authors: gunawan r. Cancer Chemother Pharmacol. 2016 Feb;77(2):405-12. doi: 10.1007/s00280-015-2955-9. Epub 2016 Jan 20. Cancer Chemother Pharmacol. 2016. PMID: 26791869 Free PMC article. Clinical Trial.
115 results