90Yttrium-labelled Anti-CD66 Monoclonal Antibody as Part of a Reduced Toxicity Conditioning Regimen Prior to Allogeneic Haematopoietic Stem Cell Transplantation: an Open Label, Phase II Study in Children and Adolescents With High Risk Leukaemia

Children affected by high risk or relapsed/refractory leukaemia have a poor prognosis, with an increased risk of relapse. These patients generally need treatment intensification and a bone marrow transplantation (BMT).
Nevertheless, with conventional treatent the risk of relapse after transplant remains high.
Radioimmunotherapy provides a way to deliver high dose irradiation to the bone marrow (where leukaemia resides), while sparing normal organs and tissues from its toxicity.This can be achieved by linking a radioactive molecule (Yttrium90) to an antibody that, once infused in the blood, targets marrow/leukemic cells.

开始日期2023-09-29

申办/合作机构

Great Ormond Street Hospital for Children NHS Foundation Trust

EUCTR2013-000015-24-GB / Not yet recruiting临床1期IIT

90-Yttrium-labelled anti-CD66 monoclonal antibody as part of a reduced intensity conditioning regimen prior to allogeneic haematopoietic stem cell transplantation: an open label, dose escalating phase I study in children with relapsed/refractory leukaemia - 90Y-antiCD66 monoclonal ab in childhood relapsed/refractory leukaemia

开始日期2015-04-10

申办/合作机构-

100 项与 Tc 99m besilesomab 相关的临床结果

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100 项与 Tc 99m besilesomab 相关的专利（医药）

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项与 Tc 99m besilesomab 相关的文献（医药）

2024-09-23·INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Transplanted Murine Tumours SPECT Imaging with ^99mTc Delivered with an Artificial Recombinant Protein.

Article

作者: Finogenova, Yulia A ; Skribitsky, Vsevolod A ; Shpakova, Kristina E ; Pozdniakova, Natalia V ; Lipengolts, Alexey A ; Smirnova, Anna V ; Grigorieva, Elena Y ; Shevelev, Alexei B

^99mTc is a well-known radionuclide that is widely used and readily available for SPECT/CT (Single-Photon Emission Computed Tomography) diagnosis. However, commercial isotope carriers are not specific enough to tumours, rapidly clear from the bloodstream, and are not safe. To overcome these limitations, we suggest immunologically compatible recombinant proteins containing a combination of metal binding sites as ^99mTc chelators and several different tumour-specific ligands for early detection of tumours. E1b protein containing metal-binding centres and tumour-specific ligands targeting integrin α_vβ₃ and nucleolin, as well as a short Cys-rich sequence, was artificially constructed. It was produced in E. coli, purified by metal-chelate chromatography, and used to obtain a complex with ^99mTc. This was administered intravenously to healthy Balb/C mice at an activity dose of about 80 MBq per mouse, and the biodistribution was studied by SPECT/CT for 24 h. Free sodium ^99mTc-pertechnetate at the same dose was used as a reference. The selectivity of ^99mTc-E1b and the kinetics of isotope retention in tumours were then investigated in experiments in C57Bl/6 and Balb/C mice with subcutaneously transplanted lung carcinoma (LLC) or mammary adenocarcinoma (Ca755, EMT6, or 4T1). The radionuclide distribution ratio in tumour and adjacent normal tissue (T/N) steadily increased over 24 h, reaching 15.7 ± 4.2 for EMT6, 16.5 ± 3.8 for Ca755, 6.7 ± 4.2 for LLC, and 7.5 ± 3.1 for 4T1.

2023-12-01·Bone reports

Semi-quantitative analysis with 99mTc-Besilesomab in musculoskeletal system infections

Article

作者: Guardia-Jimena, Patricia ; Becerra-García, Diego ; Guirado, Damián ; Arenas Aguaza, Raquel ; González Ramírez, Amanda Rocío ; Martínez-Valle Torres, María Dolores

Objectives:

To evaluate the usefulness of ^99mTc-Besilesomab to diagnose infectious processes by using monoclonal antibodies BW 250/183 in a semi-quantitative analysis, and to determine the effect on diagnostic capacity of different thresholds for the difference between counts in early versus delayed images.

Methods:

The study included 77 patients with suspected osteomyelitis who underwent scintigraphy with ^99mTc-Besilesomab. After confirming the absence of human anti-mouse antibodies in all patients, early and delayed static images were acquired at 4 and 24 h post-injection, respectively. Visual and semi-quantitative analyses were conducted of regions of interest (ROIs) in areas suspected of infection on early and delayed images. Findings were considered positive when the ratio between counts in delayed and early images exceeded a given threshold after correction for decay. The definitive diagnosis was obtained by clinical follow-up, microbiological culture, or response to medical and/or surgical treatment.

Results:

The optimal threshold was 1.02 (i.e., positive result = count increase of >2 % in delayed image), obtaining a sensitivity of 0.864, specificity of 0.858, positive predictive value of 0.708, negative predictive value of 0.940, and accuracy of 0.860. Application of the usual threshold of 1.10 (10 %) reduced the sensitivity to 0.734.

Conclusion:

Semi-quantitative analysis of studies with ^99mTc-Besilesomab is a useful technique for the diagnosis of musculoskeletal system infections and contributes to the definitive diagnosis when visual assessments are doubtful or non-conclusive.

2020-11-01·Malaysian orthopaedic journal

Combined Techniques of Non-invasive 99mTcBesilesomab/ 99mTc-Sulfur Colloid with Hybrid SPECT/CT Imaging in Characterising Cellulitis from Symptomatic Perimegaprosthetic Infection: A Case Report

作者: Faisham, W I ; Wan-Sohaimi, W F ; Nawi, N M ; Mohd-Rohani, M F ; Tagiling, N

Megaprosthesis is used to restore the form and function of massive skeletal defects, but it is accompanied by risks of failure, mainly due to perimegaprosthetic infection (PMI). In practice, the diagnosis of infected megaprosthesis among patients with a high index of clinical suspicion, elevated serological markers, and multiple negative or inconclusive imaging can be very challenging and poses a diagnostic conundrum to many orthopaedic surgeons. We present the case of a symptomatic 26-year-old female with large B-cell lymphoma who developed cellulitis with suspected complication of PMI 15 months post-implantation. The combination of advanced nuclear medicine imaging strategies, i.e., ^99mTc-besilesomab/^99mTc-sulfur colloid scintigraphy with hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) scanning helps to characterise and delineate both infections. Invasive procedures such as joint aspiration and biopsy were avoided, and the patient was successfully treated with antibiotics. Hence, we report a case where advanced imaging modalities were decisive in the investigation of PMI.

项与 Tc 99m besilesomab 相关的新闻（医药）

2024-06-07

·医药观澜

这家核药公司拟在纳斯达克IPO，曾与远大医药达成2.5亿美元合作

▎药明康德内容团队报道 6月5日消息，Telix Pharmaceuticals公司已经申请在美国纳斯达克进行IPO，计划通过发行股票筹集2亿美元。Telix是一家总部位于澳大利亚的商业化阶段生物医药公司，专注于治疗和诊断放射性药物的开发和商业化。值得一提的是，2020年11月，远大医药曾与Telix公司达成总价不高于2.5亿美元的合作，引入后者6款放射性核素偶联药物并认购其7.6%股份。目前该6款产品已经在中国进入不同的临床研究阶段。截图来源：Telix公司招股书（参考资料[1]）根据Telix公司招股书介绍，该公司拥有广泛的治疗性放射性药物候选产品，旨在将诊断和治疗相结合，更好地为癌症和罕见疾病患者提供个性化治疗，尤其是泌尿肿瘤（前列腺癌和肾脏癌症）、神经系统肿瘤（如胶质瘤）、肌肉和骨骼系统肿瘤（肉瘤）和血液系统肿瘤。目前，Telix公司的前列腺癌显像剂产品Illuccix（68Ga-PSMA-11注射液）已经在美国、澳大利亚、新西兰和加拿大获批上市。这是一款基于放射性核素-小分子偶联技术的靶向PSMA的诊断型放射性药物，适用于转移性前列腺癌及复发性前列腺癌的诊断。另一款诊断性核药产品TLX66-CDx也已经在多个国家获批上市，用于外周骨髓感染的诊断。该产品在美国的相关权益已经授权给Curium Pharma公司。除此之外，Telix公司还拥有10余款临床在研阶段的放射性药物管线。以下将介绍该公司的部分在研产品进展，仅供读者参阅： ▲Telix公司研发管线（截图来源：Telix公司招股书） TLX591（177Lu-rosopatamab tetraxetan）：一款靶向PSMA的治疗性放射性药物，可与TLX591-CDx形成去势转移前列腺癌的放射诊疗一体化组合。该产品目前处于3期临床研究阶段，已经呈现初步积极数据，其中位放射学无进展生存期（rPFS）为8.8个月。 TLX250-CDx（锆[89Zr]吉伦妥昔单抗注射液）：一款靶向碳酸酐酶 IX（CA9）的放射性核素偶联药物（RDC）。CA9是一种在肾透明细胞癌（ccRCC）和其他许多癌种中过度表达的靶点。2023年12月，该产品已完成向美国FDA递交生物制品上市许可申请（BLA），用于诊断肾透明细胞癌。在3期临床研究中，TLX250-CDx通过PET在诊断ccRCC的敏感性和特异性上分别达到86%和87%，阳性预测值可达93%。根据远大医药公开资料，在中国，该产品目前已完成1期临床研究，进入确证性临床试验阶段。 TLX101 (131I-IPA）：一种用于治疗胶质母细胞瘤（GBM）的RDC，它可自由通过血脑屏障进入大脑，并靶向GBM中过度表达的L型氨基酸转运蛋白1（LAT-1），从而精准辐射癌细胞。该产品已获美国FDA孤儿药资格，目前正在开展2期临床研究。在中国，该产品也已经进入1期临床研究阶段。 TLX101-CDx (18F-floretyrosine）：一款用于胶质母细胞瘤PET显像的诊断性核药，拟作为TLX101的补充诊断试剂，形成诊疗一体化产品。该产品目前正在计划向FDA递交上市申请。参考资料： [1]Telix Pharmaceuticals Targets U.S. IPO. Retrieved June 05 , 2024, from https://www.nasdaq.com/articles/telix-pharmaceuticals-targets-us-ipo [2]Telix公司官网. From https://telixpharma.com/our-portfolio/pipeline/ [3]远大医药全球创新放射性核素偶联药物TLX591及TLX250-CDx取得临床进展. Retrieved June 05 , 2024, from https://mp.weixin.qq.com/s/I_rGVN0fMeZmmTE9xEhYWA [4]远大医药以总价不高于2.5亿美元引入澳大利亚Telix公司6款放射性核素偶联药物并认购其7.6%股份深化抗肿瘤领域创新壁垒布局. Retrieved Nov 01 , 2020, from https://mp.weixin.qq.com/s/-0qjuENuOUgzapSqDy3fjA 本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期放射疗法IPO上市批准并购

100 项与 Tc 99m besilesomab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10844	Tc 99m besilesomab	V09HA03	DB13979

研发状态

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适应症	国家/地区	公司	日期
骨髓炎	欧盟	CIS Bio International SA	2010-01-11
骨髓炎	冰岛	CIS Bio International SA	2010-01-11
骨髓炎	列支敦士登	CIS Bio International SA	2010-01-11
骨髓炎	挪威	CIS Bio International SA	2010-01-11