HHSN261201400018C;EPOTHILONE D FORMULATED IN POLYMER MICELLE NANOPARTICLES; POP: 09/17/2014 TO 05/16/2016

该项目旨在优化包封在稳定纳米颗粒中的埃博霉素D的主要制剂，用于治疗实体恶性肿瘤，并协助提供IND提交和转化为人体临床试验所需的GMP生产和GLP毒理学研究。优化的制剂应证明在插管大鼠模型中血浆药代动力学的改善以及在小鼠肿瘤异种移植模型中抗肿瘤功效的改善。优化的先导制剂技术将转移给Intezyne的GMP生产合作伙伴，用于生产IND提交所需的GLP动物研究材料。

This project aims to optimize the lead formulation of epothilone D encapsulated in a stable nanoparticle for the treatment of solid malignancies, and assist in providing for the GMP manufacturing and GLP toxicology studies required for IND submission and translation into human clinical trials. The optimized formulation should demonstrate improvements in plasma pharmacokinetics in a cannulated rat model as well as improved antitumor efficacy in tumor xenograft models in mice. The optimized lead formulation technique will be transferred to Intezyne's GMP manufacturing partner for production of material for the GLP animal studies necessary for IND submission.