DIRECT RADIOMETAL LABELING FOR IMAGING AND THERAPY

描述(改编自申请人的摘要)：抗体或抗体 还原和冷冻干燥的碎片，用于制备即食一步法 TC-99M放射性药物，也可以用铜-67标记。铜-67， 作为pH 5.6缓冲液中的铜(II)，简单地添加到抗体中以生成 铜-67标记抗体。这个项目的目的是确定 该反应的参数以及纯度、稳定性和 所生成的放射性标记产物的免疫反应性。在第二阶段， 将评估使用铜-67和其他放射性金属的直接标记，并 产品将在动物模型中与相同的抗体进行比较 用~(99)Tc标记。最终，放射性标记抗体将用于 治疗和PET成像研究。这种方法允许相同的抗体， 使用相同的标记化学，用几种不同的标记 放射性金属，包括氚-99m和铜-67。第三阶段研究将包括 有效的和临床相关的诊断或治疗的人体试验 治疗性放射性药物。

DESCRIPTION (Adapted from applicant's abstract): Antibodies or antibody fragments, reduced and lyophilized for use in preparing instant, one-step Tc-99m radiopharmaceuticals, can also be labeled with Cu-67. The Cu-67, as Cu(II) in a ph 5.6 buffer, is simply added to the antibody to generate the Cu-67-labeled antibody. The purpose of this project is to determine the parameters of this reaction and the purity, stability, and immuno-reactivity of the resultant radiolabeled product. During Phase II, direct labeling using Cu-67andother radiometals will be evaluated and the products will be tested in animal models compared to the same antibody labeled with Tc-99m. Ultimately, radiolabeled antibodies will be made for therapy and PET imaging studies. This approach permits the same antibody, using the same labeling chemistry, to be labeled with several different radio metals, including Tc-99m and Cu-67. Phase III studies will include human trials of validated and clinically relevant diagnostic or therapeutic radiopharmaceuticals.