Center for Translational Cancer Nanomedicine

转化癌症纳米医学中心

• 批准号: 8134375
• 负责人: Vladimir P Torchilin
• 金额: $ 255.89万
• 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/8134375
• 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.

拟议的中心旨在快速地翻译我们对一组广泛的纳米药物的纳米药物的研究，并通过开发适当的技术并将其扩展以使其扩展到真正的工业产品中，以深入的物理化学化学，体内置换和成像研究为真实的工业产品在GMP/GLP条件下生产用于临床前和临床评估的候选者的测试批次。我们将在波士顿的东北大学（NU）与贝丝以色列执事医院合作建立癌症纳米技术中心（CCNE）；哈佛医学院；罗格斯，新泽西州立大学，奥本大学和Nemucore Medical Innovations，Inc。拟议的CCNE将与新泽西州NIH指定的癌症研究所合作。 CCNE将利用基于NU的高速纳米制造中心（NSF资助的纳米级科学与工程中心）的支持和设施。 跨学科的合作将使基本生物学知识基础与物理科学和工程方法相结合，从而深入参与扩大和制造，以迅速将基准研究转化为动物测试和GMP的生产，并范围缩小发现与抗癌者之间的差距疗法。 CCNE将集中在多功能的，有针对性的设备上，这些设备将绕过高局部浓度以高局部浓度（直接定时）直接向癌细胞递送多种治疗剂的生物学障碍。该中心的主要目的是在GMP条件下在体外和体内开发，在体外和体内进行临时测试，对癌症最有希望的纳米反应的测试批次进行表征，扩展和制造。纳米载体将包括聚合物胶束，脂质体，聚合物颗粒和树突聚合物，而要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）创建和提供适当的“起始材料”； b）通过体外研究建立概念验证； c）使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）开发生产方案，用于用于癌症治疗和诊断的广泛纳米置换。 公共卫生相关性：我们预计该模型计划将避免与碎片基础研究相关的问题，许多独立调查的开发工作。该中心是在实验室中显示为有效抗肿瘤剂的GMP/GLP条件下的快速扩大和发育的组织。该中心将提供迅速，有意义的临床试验所需的候选药物的质量和数量。