SBIR Phase I: PET Radiotracer Synthesis

这个小企业创新研究第一阶段项目将支持一种新的合成化学方法，用于制造正电子发射断层扫描（PET）成像产品，以治疗神经退行性疾病、癌症和心血管疾病。制造这些成像产品依赖于用放射性同位素（[18F]氟化物）快速有效地标记示踪分子。放射性氟化化学固有的困难严重限制了可用于临床的放射性示踪剂的范围。NSF SBIR第一阶段项目利用公司？美国专利的一步氟化技术。该技术以简单、快速、高效的放射性氟化技术推进了当前最先进的技术，使全新一类药物首次被标记为无载体添加[18F]氟化物。该项目将专注于儿科癌症和帕金森临床相关放射性示踪剂的合成。年代的疾病。将利用这种支持进行的技术研究包括跨多个放射性合成平台优化这种新的放射性氟化制造方法。该项目的更广泛的影响/商业潜力是提供技术，以扩大PET作为确定疾病识别和分期以及评估治疗方案疗效的平台的范围。PET是一种未充分利用的诊断成像技术，由于缺乏高效、广泛适用的放射性氟化方法而受到阻碍。这里开发的放射性示踪剂制造技术具有极强的通用性，适用于新型PET显像剂的制备。这种通用标记技术的可用性还可以通过提供新的治疗药物的体内生物标志物来加速新药的开发，这些生物标志物可用于确定新药的最佳剂量和目标人群中生物分布的可变性。PET成像的商业潜力是巨大的；到2015年，PET的全球市场预计将增长到150亿美元。随着新的显像剂的出现，这一市场也有显著扩张的空间。

This Small Business Innovation Research Phase I project will support a new synthetic chemical approach for the creation of positron emission tomography (PET) imaging products to manage neurodegenerative disorders, cancer, and cardiovascular disease. Creating these imaging products relies on the rapid and efficient labeling of tracer molecules with a radioisotope ([18F]fluoride). The difficulties inherent in radiofluorination chemistry have severely limited the scope of radiotracers available for clinical use. This NSF SBIR Phase 1 project addresses this critical problem using the company?s proprietary single-step fluorination technology. This technology advances the current state-of-the-art with simple, fast, and highly efficient radiofluorination, permitting an entire new class of drugs to be labeled with no-carrier-added [18F]fluoride for the first time. The project will focus on the synthesis of clinically relevant radiotracers for pediatric cancer and Parkinson?s disease. Technical studies to be performed using this support include optimization of this new radiofluorination manufacturing methodology across multiple radiosynthesis platforms.The broader impact/commercial potential of this project is to provide technology to expand the scope of PET as a platform for determining the identification and staging of diseases, and assessing the efficacy of treatment regimens. PET is an underutilized diagnostic imaging technique that is stymied by the lack of highly efficient, broadly applicable radiofluorination methods. The radiotracer manufacturing technology developed here is extremely general and applicable to the preparation of new imaging agents for PET. The availability of this general labeling technique can also speed development of new drugs by providing in vivo biomarkers of new therapeutic agents which can be used to determine optimal dosing of new drugs and variability of biodistribution in target populations. The commercial potential of PET imaging is significant; the worldwide market for PET is expected to grow to $15 billion by 2015. There is also room for significant expansion of this market as new imaging agents become available.