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创新型载伊立替康纳米胶束将于2021年进入I期临床试验。

Innovative Irinotecan-Loaded Nanomicelles Will Enter Phase I Clinical Trial in 2021.

作者信息

Li Chan, Xu Jing, Gan Yaling, Liang Xing-Jie

机构信息

CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety, CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, No. 11, First North Road, Zhongguancun, Beijing 100190, P. R. China.

University of Chinese Academy of Sciences, Beijing 100049, P. R. China.

出版信息

Innovation (Camb). 2020 Nov 4;1(3):100057. doi: 10.1016/j.xinn.2020.100057. eCollection 2020 Nov 25.

Abstract

Recent progress at the National Center for Nanoscience and Technology of China has enabled an extremely facile method to encapsulate irinotecan (CPT-11) into micelle-based nanoparticles (named as IH-NM). In preclinical study, compared with free CPT-11, IH-NM exhibited 1.56-fold higher maximum tolerance dose (MTD), ∼2.45-fold higher antitumor efficacy at 80% of MTD dosage, higher plasma exposure, and slower clearance from the plasma. The IH-NM technology received Clinical Trial Permission from the National Medical Products Administration (NMPA) of China on Mar 6, 2019. The Phase I clinical trial is under preparation.

摘要

中国国家纳米科学中心的最新进展实现了一种极其简便的方法,可将伊立替康(CPT-11)封装到基于胶束的纳米颗粒中(命名为IH-NM)。在临床前研究中,与游离CPT-11相比,IH-NM的最大耐受剂量(MTD)高1.56倍,在80%的MTD剂量下抗肿瘤疗效高约2.45倍,血浆暴露量更高,从血浆中清除的速度更慢。IH-NM技术于2019年3月6日获得中国国家药品监督管理局(NMPA)的临床试验许可。I期临床试验正在筹备中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c324/8454605/88a0f73033c1/gr1.jpg

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