IMAGING THROMBOEMBOLISM WITH FIBRIN AVID TC-99M-PEPTIDE

描述（申请人的摘要逐字）：每年在美国，超过 50万名患者因静脉血栓形成（VT）和肺血栓而住院治疗。 栓塞（PE）。在这些患者中，近20万人死亡。尽管宏伟的 随着成像技术的进步，VT和PE的诊断仍然是 挑战性由于动脉造影成像技术简单、无创， 允许快速扫描整个身体，FDA最近批准了 Tc-99 m-AcuTect用于凝块成像。然而，AcuTect既不能成像旧凝块， 也检测不到大多数PE。 无论是新的还是旧的VT，以及PE，fixtures都是一个主要的、不可分割的组成部分。期间 我们的NIH I期研究开发了Tc-99 m-纤维蛋白特异性肽， 其体外和体内成像结果是有希望的。我们的主要目标 II期研究旨在评价该药剂（Tc-99 m/ TP 850）的能力 i）对长达96小时的VT和PE进行成像，ii）比较Tc-99 m-TP的疗效 850例患者使用Tc 99 m-AcuTect对VT和PE进行成像，iii）检查 Tc-99 m-TP 850对新鲜和陈旧性VT和PE进行体内成像， 抗凝血剂肝素，和iv）进行药代动力学和 10名健康志愿者的辐射剂量学研究。我们认为 这些研究的结果将使我们能够确定 Tc-99 m-TP 850，使我们能够迅速启动临床试验。 拟议的商业应用： 在猪中的拟议评价和人类I期研究之后，该药物应准备好在DVT和PE患者中进行检查。由于目前没有比造影剂更能提供陈旧（24小时或更长时间）凝块和PE的“热点”图像的试剂，因此该试剂的商业潜力非常高。

DESCRIPTION (Applicant's abstract verbatim): Each year in the USA, more than 500,000 patients are hospitalized with venous thrombosis (VT) and pulmonary embolism (PE). Of these patients, nearly 200,000 die. Despite the magnificent advances in imaging techniques, diagnosis of VT and PE continues to be challenging. Because scintigraphic imaging technique is simple, non-invasive, and permits rapid scanning of the entire body, the FDA has recently approved Tc-99m-AcuTect for imaging clots. AcuTect, however, can neither image old clots nor detect most PE. Fibrin is a major, integral part of VT, fresh or old, as well as of PE. During our NIH Phase I study we have developed Tc-99m-fibrin specific peptide, with which in vitro and in vivo imaging results are promising. Our primary goals in the Phase II studies are to evaluate the ability of this agent (Tc-99m/ TP 850) i) to image up to 96 hr old VT and PE, ii) to compare the efficacy of Tc-99m-TP 850 with Tc 99m-AcuTect to image VT and PE, iii) to examine the efficacy of Tc-99m-TP 850 to image fresh and old VT and PE treated in vivo with anticoagulating agent heparin, and iv) to perform pharmacokinetics and radiation dosimetry studies in 10 healthy human volunteers. We believe that the results of these studies will allow us to determine the full potential of Tc-99m-TP 850 and permit us to rapidly initiate clinical trials. PROPOSED COMMERCIAL APPLICATIONS: Following the proposed evaluation in swine and Phase I studies in humans, the agent should be ready to be examined in patients with DVT and PE. Because there are no agents currently available than can scintigraphically provide "hot spot" images of old (24 hr or older) clots and PE, the commercial potential for this agent is very high.