CORE--ANALYTICAL AND ANIMAL

核心D（分析和动物核心）的作用是提供支持， 项目1、2和3分三个领域： 1)进行抗CEA临床前评价的体外试验 在项目2中开发的构建体和免疫融合物。 这些措施包括： 抗CEA测定免疫反应性，B）IL-2和γ-干扰素生物测定 和ELISA测定来表征和评估 c）动物肿瘤样品的CEA免疫组织化学。 2)进行动物（鼠）研究，用于临床前评价 项目开发的新型抗CEA生物工程构建体和螯合物 2和3 这些包括：a）生物分布/成像研究， 用I-123或In-111标记的中等分子量构建体，B） 评价与抗CEA缀合的新型螯合物的生物分布研究 用In-111或Cu-64标记的抗体构建体， 工程免疫融合的生物分布和功能活性 构建体（微抗体-IL-2和scFv-γ-干扰素免疫融合物），d） 评价90 Y标记构建体的治疗效果的研究，以及 e）之前所有临床小瓶化批次抗体的生物分布研究 计划中的临床试验 3)对从患者中获得的临床样本进行核心研究 进入项目1的成像和治疗试验。 这些研究 包括：a）血液、尿液和组织In-111、90-Y和I-123计数 活检样品，B）骨髓样品的In-111和90-Y计数，c） 对血液样品进行人抗嵌合抗体和抗录音带测定， 和d）血液和尿液样品的HPLC分析。

The role of Core D (Analytical and Animal Core) is to provide support to Projects 1, 2, and 3 in three areas: 1) To perform in vitro assays for pre-clinical evaluation of anti-CEA constructs and immunofusions developed in Project 2. These include: a) anti-CEA assays immunoreactivity, b) IL-2 and gamma-interferon bioassays and elisa assays to characterize and assess functional activity of the immunofusions, and c) CEA immunohistochemistry of animal tumor samples. 2) To perform animal (murine) studies for pre-clinical evaluation of novel anti-CEA bioengineered constructs and chelates developed in Projects 2 and 3. These include: a) biodistribution/imaging studies evaluating intermediate molecular weight constructs labeled with I-123 or In-111, b) biodistribution studies evaluating novel chelates conjugagted to anti-CEA antibody constructs labeled with In-111 or Cu-64, c) studies evaluating biodistribution and functional activity of engineered immunofusion constructs (minibody-IL-2 and scFv-gamma-interferon immunofusions), d) studies evaluating the therapeutic effects of 90Y labeled constructs, and e) biodistribution studies of all clinical vialed lots of antibody prior to planned clinical trials. 3) to perform core studies on clinical samples obtained from patients entered on imaging and therapy trials in project 1. These studies include: a) In-111, 90-Y and I-123 counting of blood, urine, and tissue biopsy samples, b) In-111 and 90-Y counting of bone marrow samples, c) human anti-chimeric antibody and anti-audiotape assays on blood samples, and d) HPLC analysis of blood and urine samples.