A hindsight reflection on the clinical studies of poly(l‐glutamic acid)‐paclitaxel. (11th September 2017)

• Record Type: Journal Article
• Authors: Zhao, Jun; Koay, Eugene J.; Li, Tingting; Wen, Xiaoxia; Li, Chun
• Is Part Of: Wiley interdisciplinary reviews. Volume 10:Number 3(2018)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2017-09-11
• Subjects: Nanomedicine -- Periodicals; Nanotechnology -- Periodicals; Biotechnology -- Periodicals; Ultrastructure (Biology) -- Periodicals; 610.28
• DOI: 10.1002/wnan.1497
• Languages: English
• ISSNs: 1939-5116

Abstract

Abstract : Chemotherapy for cancer treatment is limited by the excessive toxicity to normal tissues. The design of chemodrug‐loaded nanoformulations provides a unique approach to improve the treatment efficacy while minimizing toxicity. Despite the numerous publications of nanomedicine for the last several decades, however, only a small fraction of the developed nanoformulations have entered clinical trials, with even fewer being approved for clinical application. Poly(l ‐glutamic acid)‐paclitaxel (PG‐TXL) belongs to the few formulations that reached phase III clinical trials. Unfortunately, the development of PG‐TXL stopped in 2016 due to the inability to show significant improvement over current standard care. This review will provide an overview of the preclinical and clinical evaluations of PG‐TXL, and discuss lessons to be learned from this ordeal. The precise identification of suitable patients for clinical trial studies, deep understanding of the mechanisms of action, and an effective academic‐industry partnership throughout all phases of drug development are important for the successful bench‐to‐bedside translation of new nanoformulations. This article is categorized under: Implantable Materials and Surgical Technologies > Nanomaterials and Implants Therapeutic Approaches and Drug Discovery > Nanomedicine for Oncologic Disease Biology-Inspired Nanomaterials > Peptide‐Based Structures Abstract : Chemical structure of PG‐TXL (Reprinted with permission from Ref 9. Copyright 2008 Elsevier).