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

HHSN261201400018C；埃坡霉素D以聚合物胶束纳米粒子配制；

• 批准号: 8948043
• 负责人: KEVIN SILL
• 金额: $ 94.5万
• 依托单位: INTEZYNE TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-18 至 2016-05-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8948043
• 关键词: Animal Model; Animals; Canis familiaris; Clinical Trials; Dose; Drug Formulations; Drug Kinetics; Encapsulated; Human; Lead; Malignant Neoplasms; Methods; Micelles; Modeling; Mus; Pharmaceutical Preparations; Plasma; Polymers; Production; Rattus; Solid; Techniques; Toxic effect; Toxicology; Translations; Xenograft Model; epothilone D; improved; nanoparticle; scale up; tumor xenograft

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.

该项目旨在优化封装在稳定纳米颗粒中的埃坡霉素 D 的先导制剂，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。优化的配方应能改善插管大鼠模型中的血浆药代动力学，并改善小鼠肿瘤异种移植模型中的抗肿瘤功效。优化的先导制剂技术将转移给 Intezyne 的 GMP 制造合作伙伴，用于生产 IND 提交所需的 GLP 动物研究材料。