更新于：2023-09-06

Indium (111In) Biciromab(Janssen Global Services LLC)

更新于：2023-09-06

概要

研发状态

概要

基本信息

药物类型

放射标记抗体、诊断用放射药物、单克隆抗体

别名

T2G1S、FibriScint

靶点

FGB(纤维蛋白原β链)

作用机制

FGB抑制剂(纤维蛋白原β链抑制剂)、SPECT(单光子发射计算机断层成像术增强剂)

治疗领域

心血管疾病、其他疾病

在研适应症-

非在研适应症

诊断试剂、血栓栓塞

原研机构

Janssen Services, LLC

在研机构-

非在研机构

Janssen Services, LLC

最高研发状态(全球)撤市

首次获批日期(全球)-

最高研发状态(中国)-

特殊审评-

关联

100 项与 Indium (111In) Biciromab(Janssen Global Services LLC) 相关的专利（医药）

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项与 Indium (111In) Biciromab(Janssen Global Services LLC) 相关的文献（医药）

1992-01-01·Circulation1区 · 医学

Noninvasive arterial thrombus imaging with 99mTc monoclonal antifibrin antibody.

1区 · 医学

Article

作者: M D Cerqueira ; J R Stratton ; R Vracko ; T F Schaible ; J L Ritchie

BACKGROUND:

The T2G1s monoclonal antifibrin antibody binds specifically to fibrin but not to fibrinogen.

METHODS AND RESULTS:

In a canine model of acute arterial thrombosis, we determined the feasibility of imaging thrombi using a 99mTc-labeled Fab' fragment. In 14 dogs, 10 carotid and 13 femoral artery thrombi were produced using 2-hour temporary occlusion, crush injury, and local thrombin injection methods. A sham-operated carotid artery served as control. Antifibrin antibody was injected intravenously at the end of temporary occlusion. Serial planar radionuclide images were obtained immediately and at 1 and 2 hours. Following killing the dogs at 2 hours, we measured antibody uptake ex vivo in 5-mm-long segments of thrombus, the adjacent injured artery, and a control artery. Antibody was cleared from the blood with a mean +/- SD t1/2 of 121 +/- 23 minutes. The thrombi weighed 218 +/- 140 mg. Antibody uptake in the thrombi was patchy, and the thrombi were closely adherent to the injured arterial wall. In the segment with maximal ex vivo antibody uptake, the ratio of control artery to blood counts/g/sec was 0.65 +/- 0.46, the injured artery-to-blood ratio was 2.35 +/- 1.01 (p less than 0.0001 versus control), and the thrombus-to-blood ratio was 4.24 +/- 2.58 (p less than 0.0001 versus control). In three dogs, an isotype-matched ovarian tumor antibody labeled with 111In was injected with T2G1s but was not taken up in the thrombus or the adjacent arterial wall. Visual analysis of the in vivo carotid radionuclide images showed uptake by 2 hours in all 10 carotid thrombi. Quantitative image analysis, measured as the thrombus-to-opposite carotid artery ratio, showed increasing uptake over time with ratios of 1.1 +/- 0.3, 1.6 +/- 2.0, and 2.2 +/- 1.3 on the immediate, 1-hour, and 2-hour images, respectively. All quantitative ratios of 1.3 or greater were visually identified.

CONCLUSIONS:

99mTc-labeled Fab' fragments of the T2G1s antibody are taken up specifically by acute arterial thrombi after intravenous injection. Uptake is progressive over a 2-hour period, and all thrombi are detected by radionuclide imaging at 2 hours. These results show that it is feasible to noninvasively detect arterial thrombi within 2 hours of formation.

1991-10-01·Seminars in nuclear medicine2区 · 医学

Antifibrin scintigraphy in the diagnostic evaluation of acute deep venous thrombosis.

2区 · 医学

Review

作者: T F Schaible ; A Alavi

Antifibrin scintigraphy is a new and innovative approach to the diagnosis of acute deep venous thrombosis (DVT). Many antifibrin monoclonal antibodies (Mo-Abs) have been described, but only two, 59D8 and T2G1s, have undergone broad preclinical or clinical investigation. Both of these MoAbs recognize an epitope on the amino terminal end of fibrin. The epitope for 59D8 and T2G1s is available for binding only on newly formed, acute thrombi. Preclinical studies have confirmed the specificity of these MoAbs for acute DVT, and have demonstrated their ability to image experimentally induced DVT. Preliminary clinical studies in patients with signs or symptoms of DVT have evaluated indium-111 59D8 Fab and technetium-99m T2G1s Fab'. Fragments of the intact MoAbs are employed to promote faster blood clearance and to reduce immunogenicity. The initial clinical studies indicate that antifibrin scintigraphy has a diagnostic accuracy approaching 90%. Antifibrin scintigraphy has the potential for overcoming many of the deficiencies of both invasive (contrast venography) and noninvasive (Doppler/ultrasound, impedance plethysmography) methods for detecting DVT. With a single procedure, it provides an accurate and rapid evaluation of both lower extremities, both above and below the knee. Because of its unique specificity for acute DVT, it should have excellent potential for use in patients with suspected acute, recurrent DVT, a condition difficult to diagnose by all currently employed tests for DVT.

1990-06-01·Journal of nuclear medicine : official publication, Society of Nuclear Medicine1区 · 医学

Thrombus imaging: a comparison of radiolabeled GC4 and T2G1s fibrin-specific monoclonal antibodies.

1区 · 医学

Article

作者: S F Rosebrough ; J G McAfee ; Z D Grossman ; B J Kudryk ; C A Ritter-Hrncirik ; L S Witanowski ; B L Maley ; E A Bertrand ; G M Gagne

Radioimmunoimaging of experimentally-induced canine thrombi has previously been achieved with iodine-131- and indium-111-labeled (131I and 111In) anti-fibrin T2G1s monoclonal antibody (MAb). We now compare T2G1s to another anti-fibrin MAb, designated GC4, for imaging fresh and aged canine thrombi. GC4 is specific for a neoepitope exposed on fibrin later in the thrombolytic process after plasmin digestion. Femoral venous thrombi were induced in six groups of dogs, each containing three dogs. In two groups, the MAbs were compared when the thrombi were 3-hr or 3-days old at the time of injection, and the dogs were killed at 48 hr. In thrombi 3-hr-old, the GC4/T2G1s concentration ratio averaged 0.53 compared to 1.9 in 3-day-old thrombi. Two groups of dogs with thrombi 1- or 3-days-old were heparinized before MAb injection and were killed at 24 hr. The heparinized dogs with thrombi 1- or 3-days-old had GC4/T2G1s mean ratios of 2.3 and 2.9, respectively. In the unheparinized groups, the corresponding ratios were 1.1 and 1.9. GC4 may be more useful for clinical thrombus imaging than T2G1s because spontaneous venous thrombi are usually several days old at the time of presentation and patients are often heparinized immediately.