Production, validation, and commercialization of MagniLium (hyperpolarized helium

MagniLium（超极化氦气）的生产、验证和商业化

• 批准号: 7271427
• 负责人: Jan H Distelbrink
• 金额: $ 17.25万
• 依托单位: XEMED, LLC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-05-15 至 2008-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7271427
• 关键词: Alkalies; Alveolar; American; Budgets; Chronic Obstructive Airway Disease; Clinical; Clinical Research; Collaborations; Contrast Media; Development; Diagnosis; Diagnostic; Diffusion; End Point; Europe; Functional Imaging; Gases; Generic Drugs; Goals; Grant; Healthcare; Helium; Human; Image; Individual; Investigational Drugs; Investigational New Drug Application; Lasers; Laws; Legal; Legal patent; Licensing; Lung; Magnetic Resonance Imaging; Measures; Medical; Names; Optics; Output; Oxygen; Paris, France; Performance; Perfusion; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Phase I Clinical Trials; Production; Pulmonary Emphysema; Pump; Rate; Relaxation; Research; Research Infrastructure; Sales; Schedule; Services; Smoker; Stifle joint; Techniques; Technology; Temperature; United States Food and Drug Administration; Validation; Variant; Xenon; commercialization; cost; day; density; drug development; improved; novel; physical process; pressure; prototype; research and development

DESCRIPTION (provided by applicant): Hyperpolarized gas MRI offers unprecedented pulmonary functional diagnostic capability. Pharmaceutical companies require sensitive diagnostic end points to determine the efficacy of COPD therapies they have under development and accelerate their progress through FDA approval and into the marketplace. Individual sufferers of COPD could benefit from improved diagnosis and treatment. The US healthcare budget could benefit if the $35B spent on the 30 million Americans suffering from COPD could be directed towards effective treatments through accurate assessments. The primary obstacle to progress has been the availability of high quality hyperpolarization technology and services for both technical and legal reasons. We see a clear path to overcoming those obstacles. We propose to assemble a world-leading 3He polarizer using the low-cost spin-exchange optical pumping technique. New optical pumping technologies, many developed by us only recently and others to be developed in this proposal, will allow production of 55% polarization at 100 bar-liters per day and as high as 70% polarization at one-third that rate. This phase of the project includes submission of the product gas as an Investigational New Drug (IND) to the US FDA. A subsequent phase will include refinement and duplication of the prototype, utilization of the prototype to partner with clinical and pharmaceutical research centers for human trials, and submission of a New Drug Application (NDA) to the FDA. FDA safe harbor laws protect drug development as a non-infringing activity.

描述(申请人提供)：超极化气体磁共振提供前所未有的肺功能诊断能力。制药公司需要敏感的诊断终点来确定他们正在开发的COPD疗法的疗效，并通过FDA的批准和进入市场加快进展。个别COPD患者可以从改进的诊断和治疗中受益。如果花在3000万美国慢性阻塞性肺病患者身上的350亿美元能够通过准确的评估用于有效的治疗，美国的医疗预算可能会受益。由于技术和法律原因，取得进展的主要障碍是能否获得高质量的超极化技术和服务。我们看到了一条克服这些障碍的明确道路。我们计划利用低成本的自旋交换光学泵浦技术组装世界领先的3He偏振器。新的光泵浦技术，其中许多是我们最近才开发的，另一些将在本方案中开发，将允许在每天100巴升的情况下产生55%的偏振，并且在三分之一的速率下产生高达70%的偏振。该项目的这一阶段包括将产品GAS作为一种研究新药(IND)提交给美国FDA。后续阶段将包括改进和复制原型，利用原型与临床和药物研究中心合作进行人体试验，以及向FDA提交新药申请(NDA)。FDA的安全港法律将药物开发作为一种非侵权活动加以保护。