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 相关的转化医学

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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 ; Mohd-Rohani, M F ; Nawi, N M ; 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）

2024-10-16

·PRNewswire

Telix Featured in 13 Abstracts at the Annual Congress of the European Association of Nuclear Medicine (EANM)

MELBOURNE, Australia, Oct. 16, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces thirteen abstract presentations featuring the Company's ongoing theranostic development, medical technologies (MedTech), and research and innovation (R&I) programs at the 37th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Hamburg from 19 – 23 October 2024. Telix's extensive theranostic pipeline will be showcased in presentations covering: TLX250-CDx (Zircaix®[1], 89Zr-girentuximab) kidney cancer imaging, including first real-world clinical experience; TLX101 (131I-iodofalan or 131I-IPA) glioblastoma therapy; TLX66 (90Y-besilesomab) bone marrow conditioning therapy; TLX252 (225Ac-girentuximab) carbonic anhydrase IX (CAIX)-targeted alpha therapy; and SENSEI®, Lightpoint's robotic-assisted gamma probe. Dr. David N. Cade, Telix Group Chief Medical Officer, said, "We are pleased to be able to so comprehensively showcase our pipeline at EANM – the largest gathering of nuclear medicine professionals worldwide – with a sponsored symposium, and abstracts accepted across Telix's late-stage theranostic programs in kidney and brain cancers, and in bone marrow conditioning. As in previous years, it is an honour for us to support the EANM Sanjiv Sam Gambhir Young Investigator Award. This is an exciting opportunity for a junior physician or scientist to further develop their career in radiopharmaceuticals, in memory of an extraordinary man and an inspiring educator." We look forward to seeing delegates at Telix's booth in Hall H, Stand H29 to discuss Telix's industry leading theranostic pipeline in urologic oncology (prostate, kidney and bladder cancers), neuro-oncology (glioma), musculoskeletal oncology (sarcoma) and hematology, our associated medical devices, and opportunities for collaboration. EANM presentation details are as follows: Sponsored Symposium: Does size matter in targeted radionuclide therapies? Chairperson: Professor Viktor Grünwald, University Hospital Essen, Essen, Germany. Why size matters: The relative benefits of antibodies vs. small molecules in oncology Prof. Arturo Chiti, IRCCS San Raffaele Hospital, Milan, Italy When small may be smart: The role of small molecules in neuro-oncology Prof. Nathalie Albert, Ludwig-Maximilian's-University of Munich, Munich, Germany Where big may be best: The power of antibodies in onco-hematology Prof. Stefano Fanti, University of Bologna, Bologna, Italy How size will shape the future: The choice between antibodies and small molecules in uro-oncology Prof. Karolien Goffin, University Hospital Leuven, Leuven, Belgium Date & Time: Sunday, 20 October, 2024, 13:15 – 14:45 CEST Location: Hall G1, Congress Center Hamburg Abstract presentations Title: Unravelling radiobiological and immunological mechanisms driving effective CAIX-TRT and ICI combination therapy Presenter: S. Kleinendorst, RadboudUMC, Netherlands Date and Time: 20-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track - TROP Session: Dosimetry Committee: Preclinic and Radiobiology Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-022 Title: Accuracy of personalised single time point dosimetry for bone marrow and liver dosimetry in TLX66 (90Y-Anti CD66) radioimmunotherapy Presenter: A. Nautiyal, University Hospital Southampton, United Kingdom Date and Time: 20-Oct-24, 15:00 – 16:30 Session: Cutting Edge Science Track - TROP Session: Dosimetry Committee: Dosimetry: A Question of Time Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-158 Title: Tumour margin thickness inference for 99mTc radio-guided surgery using internal conversion electrons Presenter: J. Moo, Telix Date and Time: 21-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track - TROP Session: Physics Committee: Data Corrections / Image Enhancement Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-289 Title: Radiation protection considerations with TLX250-CDx (89Zr-girentuximab) PET/CT experience in France Presenter: C. Morgat, Department of Nuclear Medicine, University Hospital of Bordeaux, France Date and Time: 21-Oct-24, 15:00 – 16:30 Session: TROP Session: Radiation Protection Committee: Radiation Protection in Diagnostic Imaging Procedures Format: Oral Location: Hall Y1-Y3 Presentation ID: OP-452 Title: Correlation of tracer uptake in sentinel lymph nodes as measured on SPECT/CT and during intraoperative gamma tracing with the SENSEI drop in gamma probe: the UZ Leuven experience Presenter: M. Manley, Nuclear Medicine, University Hospitals Leuven, Belgium Date and Time: 22-Oct-24, 08:00 – 09:30 Session: Cutting Edge Science Track – TROP Session: Physics Committee: SPECT/CT Quantification Format: Oral Location: Hall Y4-Y9 Presentation ID: OP-543 Title: Development of 161Tb-DOTA-HYNIC-panPSMA for targeted radionuclide therapy of prostate Cancer Presenter: C. Morgat, Department of Nuclear Medicine, University Hospital of Bordeaux, France Date and Time: 22-Oct-24, 08:00 – 09:30 Session: M2M Track - TROP Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation Format: Oral Location: Hall X1-X4 Presentation ID: OP-532 Title: Feasibility and tolerability of TLX101 (¹³¹I-IPA) monotherapy in progressive and recurrent high grade gliomas; an ongoing single institution case series Presenter: N. Tolboom, University Medical Centre Utrecht, Netherlands Date and Time: 22-Oct-24, 16:45 – 18:15 Session: TROP Session: Neuroimaging Committee: Neuro-Oncology Format: Oral Location: Hall Y10-Y12 Presentation ID: OP-758 Title: The emerging role of TLX250-CDx (89Zr-girentuximab) PET/CT in accurate characterisation and staging of ccRCC: early experience with three patients Presenter: F. Gelardi, Università Vita-Salute San Raffaele, Italy Date and Time: 23-Oct-24, 08:00 – 09:30 Session: TROP Session: Case Report Session 2: You Won't Believe the Things I've Seen! Format: Oral Location: Hall Y1-Y3 Presentation ID: OP-824 Title: Development of girentuximab as a theranostic tool in non-renal indications Presenter: A. Ivashkevich, Telix Date and Time: 23-Oct-24, 08:00 – 09:30 Session: e-Poster Presentations Session 13: Translational Molecular Imaging & Therapy Committee: Molecular Imaging & Therapy Format: Oral ePoster Location: Hall F Presentation ID: EPS-270 Title: Preclinical evaluation of DNA damage response inhibitors and TLX252 (225Ac-DOTA-girentuximab) combination therapy Presenter: Z. Cao, Olivia Newton-John Cancer Research Institute, Australia Date and Time: 23-Oct-24, 08:00 – 09:30 Session: e-Poster Presentations Session 13: Translational Molecular Imaging & Therapy Committee: Molecular Imaging & Therapy Format: Oral ePoster Location: Hall F Presentation ID: EPS-269 Title: Development of Kit-Composition for the Preparation of 99mTc-PSMA-GCK01 / RHN001-Dx Presenter: J. Cardinale, University Hospital Duesseldorf, Germany Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D57 Radiopharmaceutical Preparation and Quality Control Format: e-Poster Location: e-Poster Area Presentation ID: EP-1037 Title: Development of 18F-labelled lactate for oxidative cancer imaging Presenter: M. da Silva Morais, Pole of Pharmacology, Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain (UCLouvain), Belgium Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D55 Radiopharmacokinetics and Drug Development Format: e-Poster Location: e-Poster Area Presentation ID: EP-1010 Title: Radiolabelling DOTA-HYNIC-panPSMA with actinium-225 for in vivo studies Presenter: K. Attia, Telix Session: D: Technical Studies -> D5 Radiopharmacy/Radiochemistry -> D53 New Radiopharmaceuticals - Therapy Format: e-Poster Location: e-Poster Area Presentation ID: EP-0985 About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Telix's lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)[2], by the Australian Therapeutic Goods Administration (TGA) [3], and by Health Canada [4] . No other Telix product has received a marketing authorisation in any jurisdiction. Visit for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix®, SENSEI® and Zircaix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

放射疗法上市批准

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

2021-05-25

·BioSpace

TLX66 Meets Study Objectives in Patients with AL Amyloidosis

MELBOURNE, Australia and SOUTHAMPTON, United Kingdom, May 25, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Company’s bone marrow conditioning investigational candidate TLX66 (90Y-besilesomab) has met study objectives, demonstrating the initial safety profile in patients with Systemic Amyloid Light Chain Amyloidosis (AL amyloidosis). The TRALA trial ( T argeted R adiotherapy for AL A myloidosis) is a Phase I/IIa trial to evaluate the safety and toxicity of TLX66 as the sole bone marrow conditioning agent prior to autologous hematopoietic stem cell transplantation (HSCT) in patients with AL amyloidosis.1 The TRALA trial was sponsored by University Hospital Southampton in Southampton U.K. and run across four centres: Southampton, University College Hospital London, Royal Free Hospital London, and Queen Elizabeth Hospital Birmingham. All study data were reviewed by the trial’s Independent Data Monitoring Committee (IDMC). In total, nine patients with AL amyloidosis were enrolled into the TRALA trial and received TLX66 as the sole bone marrow conditioning agent prior to undergoing autologous HSCT. TLX66 demonstrated a favourable safety profile and was well tolerated in all nine patients, each of whom completed the trial. All patients (100%) were successfully engrafted following bone marrow conditioning with TLX66 and autologous HSCT without any chemotherapy. Disease response as measured by fall in clonal free light chains (FLC) was seen in seven out of the nine patients, with two complete responses (CR) and five partial responses (PR) within the first 100 days post-transplant. In two of the patients achieving PR, the clonal FLC continued to fall, with one patient achieving CR subsequently with no further treatment. In addition, reduction in the measurable malignant plasma cells in the bone marrow was seen in six of eight evaluable patients. All patients remain alive at a median follow-up of 31 months (range 14 – 57 months). Consultant Hematologist at University Hospital Southampton and TRALA principal investigator Dr. Kim Orchard stated, “We are highly encouraged by the safety and tolerability that 90Y-besilesomab has demonstrated as a single agent bone marrow conditioning approach in patients with AL amyloidosis. Compared to the significant toxicity profile typically experienced with conventional chemotherapy-based regimens, molecularly targeted radiation with 90Y-besilesomab demonstrated a very benign toxicity profile, which may in turn enable a considerably greater proportion of patients with AL amyloidosis to undergo life prolonging stem cell transplantation. The very low toxicity but with demonstrable responses is very encouraging.” Telix Chief Medical Officer Dr. Colin Hayward said, “The results from the TRALA trial indicate that TLX66 may offer a new approach to bone marrow conditioning in patients who could benefit from HSCT such as those with AL amyloidosis, providing new hope to patients with this rare disease and with few effective treatment options. TLX66 was well-tolerated, enabling successful engraftment of the patients’ own transplanted stem cells without the need for toxic chemotherapy. With all patients remaining alive, and most not requiring further therapy, we believe these data support taking TLX66 forward into a pivotal registration program in this rare disease indication.” About Amyloidosis Amyloidosis is a rare disease in which faulty plasma cells in the bone marrow (that normally generate antibodies in response to infection) produce an abnormal protein called ‘amyloid’ which accumulates in the organs of the body. Progressive accumulation of amyloid in organs such as the heart and kidneys eventually lead to organ failure and death. Amyloidosis occurs at the rate of ~12 per 1,000,000 population, per annum, with an estimated prevalence of 30,000 to 45,000 in the United States and European Union, respectively.2 While a rare disease, amyloidosis portends a poor prognosis, with a median survival from diagnosis of approximately 11 months if untreated. Current standard of care typically requires bone marrow conditioning with multi-drug regimens comprising cyclophosphamide, bortezomib, dexamethasone and high dose melphalan, prior to HSCT. While long-term survival is achievable in patients undergoing HSCT, such bone marrow conditioning regimens are typically highly toxic and may be poorly tolerated in a significant proportion of patients and associated with high morbidity and mortality. Consequently, safer, more tolerable conditioning agents represent a significant unmet clinical need. About Telix Pharmaceuticals Limited Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit and follow Telix on Twitter (@TelixPharma) and LinkedIn. 1 EudraCT Number: 2015-002231-18. 2 Quock TP et al. Blood Advances. 2018.

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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

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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