Targeting Deep Brain Tumors with MRI-Insertable Magnetic Gradients and Nanopartic

利用 MRI 可插入磁梯度和纳米颗粒靶向深部脑肿瘤

• 批准号: 8524216
• 负责人: Irving Weinberg
• 金额: $ 28.83万
• 依托单位: WEINBERG MEDICAL PHYSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-23 至 2014-09-22
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8524216
• 关键词: Animals; Blood - brain barrier anatomy; Brain; Brain Neoplasms; Brain region; Bypass; Caliber; Cerebellum; Contralateral; Data; Goals; Human; IACUC; Injection of therapeutic agent; Investigational New Drug Application; Left; Lesion; Letters; Magnetic Resonance Imaging; Magnetism; Marketing; Medical; Membrane; Mus; Neurosurgeon; Nose; Operative Surgical Procedures; Patients; Pharmaceutical Preparations; Phase; Physicians; Physiologic pulse; Price; Protocols documentation; Relative (related person); Residual state; Running; Site; Surface; System; Temperature; Testing; Therapeutic; Time; Toxic effect; Trauma; Universities; base; commercialization; cranium; improved; nanoparticle; phase 2 study; physical property; public health relevance; simulation; skull base; success; tumor

DESCRIPTION (provided by applicant): We wish to improve treatment for patients with deep-seated brain tumors. With the help of the MRI-guided and nanoparticle-enabled system we are constructing, therapeutic access to these tumors will be provided through the delicate nooks, crannies, and membranes of the skull. In preliminary studies, we have demonstrated the ability to bypass the blood-brain barrier traumatically and to manipulate magnetic nanoparticles (MNPs) in mouse brains. By the end of Phase I, we will have built and tested an MRI-compatible gradient insert system capable of delivering magnetic nanoparticles (MNPs) to selected regions in normal mouse brains. Using the data collected from the Phase I mouse study, we will have run simulations of a large-scale magnetic insert system, in order to demonstrate the feasibility of targeting deep- seated brain and skull-base targets in humans. Discussions are well underway with investors to match the Phase II NCI contribution (see Letter of Support). Strategic partner Chemicell is conducting toxicity and other studies in support of an eventual investigational new drug application (IND) of the drug to be used in Phase II of this study. The potential market size for this product can be estimated to be in the range of several hundred million dollars, based on either the number of potential surgical users and practice sizes (i.e., 4,000 neurosurgeons, averaging 8 physicians/practice, at an expected price per system of $1 million) or the purchase price and valuations for companies with similar products (Sentinelle Medical, acquired for $85 million by Hologic, and $2 billion valuation for Intuitive Surgical).

描述（由申请人提供）：我们希望改善深部脑肿瘤患者的治疗。在我们正在构建的MRI引导和纳米粒子启用系统的帮助下，这些肿瘤的治疗途径将通过颅骨的微妙角落，缝隙和膜提供。在初步研究中，我们已经证明了绕过血脑屏障创伤和操纵小鼠大脑中的磁性纳米粒子（MNP）的能力。到第一阶段结束时，我们将建立并测试一个MRI兼容的梯度插入系统，该系统能够将磁性纳米颗粒（MNP）输送到正常小鼠大脑的选定区域。使用从I期小鼠研究中收集的数据，我们将运行大规模磁性插入系统的模拟，以证明 以人类大脑和头骨为目标与投资者的讨论正在顺利进行，以匹配第二阶段NCI的贡献（见支持信）。战略合作伙伴Chemicell正在进行毒性和其他研究，以支持将用于本研究II期的药物的最终研究性新药申请（IND）。根据潜在手术用户的数量和实践规模（即，4,000名神经外科医生，平均8名医生/诊所，每台系统的预期价格为100万美元）或拥有类似产品的公司的收购价格和估值（Sentinelle Medical，被Hologic以8500万美元收购，Intuitive Surgical估值为20亿美元）。