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）：我们希望改善针对深层脑肿瘤患者的治疗。在我们正在构建的MRI引导和纳米颗粒系统的帮助下，将通过精致的角落，缝隙和头骨的膜提供对这些肿瘤的治疗方法。在初步研究中，我们已经证明了绕开血脑屏障并在小鼠大脑中操纵磁性纳米颗粒（MNP）的能力。到第一阶段结束时，我们将构建并测试了能够将磁性纳米颗粒（MNP）输送到正常小鼠大脑中选定区域的兼容MRI兼容梯度插入系统。使用从I期鼠标研究中收集的数据，我们将对大型磁性插入系统进行模拟，以证明 针对人类中的深座大脑和颅底靶标。与投资者进行了很好的讨论，以符合II阶段NCI贡献（请参阅支持信）。战略合作伙伴Chemicell正在进行毒性和其他研究，以支持本研究第二阶段使用的最终研究新药应用（IND）。根据潜在的手术用户和实践尺寸的数量，该产品的潜在市场规模估计在数亿美元的范围内（即4,000个神经外科医生，平均8位医生/练习，以每项预期的价格，每次预期的价格系统的系统为100万美元），或针对具有类似产品的公司的购买价格和估值（Sentinelle Medical，由HOTHOLIC以8500万美元的价格收购，直观手术的估值为20亿美元）。