Center for Translational Cancer Nanomedicine

转化癌症纳米医学中心

• 批准号: 7976256
• 负责人: Vladimir P Torchilin
• 金额: $ 259.6万
• 依托单位: NORTHEASTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7976256
• 关键词: Center; Translational; Cancer; Nanomedicine

The proposed Center is designed to provide rapid translation of our bench studies of a broad set of nanomedicines for cancer with in-depth physico-chemical, in vivo disposition and imaging studies into a real industrial product by developing the appropriate technologies and scaling them up for manufacture of test batches of candidates for preclinical and clinical evaluation under GMP/GLP conditions. We will establish a Center for Cancer Nanotechnology Excellence (CCNE) at Northeastern University (NU), Boston with collaborations at Beth Israel Deaconess Hospital; Harvard Medical School; Rutgers, The State University of New Jersey, Auburn University, and Nemucore Medical Innovations, Inc. The proposed CCNE will collaborate with the NIH-designated Cancer Institute of New Jersey and SPORE. The CCNE will utilize the support and facilities of the NU-based Center for High-rate Nanomanufacturing (NSF-funded Nanoscale Science and Engineering Center). Cross-disciplinary collaboration will enable integration of the fundamental biological knowledge base with physical science and engineering approaches for intimate involvement in scale-up and manufacture to rapidly translate bench research into animal testing and GMP production and to narrow the gap between discovery and development of anticancer therapeutics. The CCNE will concentrate on multifunctional, targeted devices that will bypass current biological barriers to delivery of multiple therapeutic agents at high local concentrations, with appropriate timing, directly to cancer cells. The main objective of the Center will be to develop, test pre-clinically in vitro and in vivo, characterize, scale up and manufacture under GMP conditions test batches of the most promising nanopreparations for cancer. Nanocarriers will include polymeric micelles, liposomes, polymeric particles, and dendrimers, while the drugs to be used will include pro-apoptotic agents, DNA, and siRNA together with diagnostic labels. The proposed CCNE will: a) create and supply appropriate "starting materials"; b) establish proof-of-concept through in vitro studies; c) conduct pharmacologic studies with animal models; d) perform a variety of in vivo model studies; e) provide quality assurance; and f) develop production schemes for a broad set of nanopreparations for cancer treatment and diagnosis. Public Health Relevance: We expect this model program will avoid the problems associated with piece-meal basic research, development efforts by many independent investigations. The Center is organized for the rapid scale-up and development, under GMP/GLP conditions, of the drugs shown in the lab to be effective anti-tumor agents. The Center will provide the quality and quantity of drug candidates necessary for prompt, meaningful clinical trials.

拟建中心旨在通过开发适当的技术并扩大生产规模以在 GMP/GLP 条件下生产用于临床前和临床评估的候选药物的测试批次，从而将我们对癌症纳米药物的广泛实验室研究以及深入的物理化学、体内处置和成像研究快速转化为真正的工业产品。我们将与贝斯以色列女执事医院合作，在波士顿东北大学 (NU) 建立癌症纳米技术卓越中心 (CCNE)；哈佛医学院；罗格斯大学、新泽西州立大学、奥本大学和 Nemucore Medical Innovations, Inc. 拟议的 CCNE 将与 NIH 指定的新泽西癌症研究所和 SPORE 合作。 CCNE 将利用 NU 高速纳米制造中心（NSF 资助的纳米科学与工程中心）的支持和设施。 跨学科合作将实现基础生物学知识库与物理科学和工程方法的整合，以便密切参与放大和制造，从而快速将实验室研究转化为动物测试和 GMP 生产，并缩小抗癌疗法的发现和开发之间的差距。 CCNE 将专注于多功能、有针对性的设备，这些设备将绕过当前的生物障碍，在适当的时机以高局部浓度直接向癌细胞输送多种治疗药物。该中心的主要目标是开发、临床前体外和体内测试、在 GMP 条件下表征、放大和生产最有前途的癌症纳米制剂的测试批次。纳米载体将包括聚合物胶束、脂质体、聚合物颗粒和树枝状聚合物，而使用的药物将包括促凋亡剂、DNA和siRNA以及诊断标签。拟议的 CCNE 将： a) 创建并提供适当的“起始材料”； b) 通过体外研究建立概念验证； c) 用动物模型进行药理学研究； d) 进行各种体内模型研究； e) 提供质量保证； f) 制定用于癌症治疗和诊断的广泛纳米制剂的生产方案。 公共卫生相关性：我们预计该模型计划将避免与许多独立调查的零碎基础研究和开发工作相关的问题。该中心的组织目的是在 GMP/GLP 条件下快速扩大和开发实验室显示的有效抗肿瘤药物。该中心将为及时、有意义的临床试验提供所需质量和数量的候选药物。