Polymer Therapeutics Lab., Centro de Investigación Príncipe Felipe, Av. Autopista del Saler 16 E-46012, Valencia, Spain.
Curr Opin Biotechnol. 2011 Aug;22(4):492-501. doi: 10.1016/j.copbio.2011.05.507. Epub 2011 Jun 14.
A growing number of polymer therapeutics have entered routine clinical use as nano-sized medicines. Early products were developed as anticancer agents, but treatments for a range of diseases and different routes of administration have followed--recently the PEGylated-anti-TNF Fab Cimzia® for rheumatoid arthritis and the PEG-aptamer Macugen® for age related macular degeneration. New polymer therapeutic concepts continue to emerge with a growing number of conjugates entering clinical development, for example PEGylated-aptamers and a polymer-based siRNA delivery system. 'Hot' topics of the past 2 years include; emerging issues relating to polymer safety, the increasing use of biodegradable polymers, design of technologies for combination therapy, potential biomarkers for patient individualisation of treatment and Regulatory challenges for 'follow-on/generic' polymer therapeutics.
越来越多的聚合物治疗药物已作为纳米药物常规应用于临床。早期的产品是作为抗癌药物开发的,但随后出现了针对一系列疾病和不同给药途径的治疗方法——最近是聚乙二醇化抗 TNF Fab Cimzia®用于类风湿关节炎和聚乙二醇化适体 Macugen®用于年龄相关性黄斑变性。随着越来越多的缀合物进入临床开发,新的聚合物治疗概念不断涌现,例如聚乙二醇化适体和基于聚合物的 siRNA 递药系统。过去两年的“热门”话题包括:与聚合物安全性相关的新问题、越来越多地使用可生物降解聚合物、联合治疗技术的设计、用于患者个体化治疗的潜在生物标志物以及“后续/仿制药”聚合物治疗的监管挑战。