[Translation] A single-center, double-blind, randomized phase I study of the pharmacokinetics and safety of BR55 in healthy volunteers and patients with diffuse pulmonary fibrosis

1. 评价BR55的药代动力学特征：1）BRU-2248的血液药代特征， 2）全氟丁烷（PFB）的血液和呼出气体的药代特征。 2. 扩展BR55的安全性特征

[Translation]

1. Evaluate the pharmacokinetic characteristics of BR55: 1) Blood pharmacokinetic characteristics of BRU-2248, 2) Blood and exhaled gas pharmacokinetic characteristics of perfluorobutane (PFB). 2. Expand the safety characteristics of BR55

Start Date18 Sep 2023

Sponsor / Collaborator

Bracco Imaging Medical Techologies (Shanghai) Co., Ltd.

[+2]

CTR20220634 / CompletedPhase 2

一项在癌症和慢性炎症性疾病患者中使用BR55进行VEGFR2（KDR）超声分子成像的多中心、随机、双盲、剂量探索II期研究

[Translation] A multicenter, randomized, double-blind, dose-finding phase II study using BR55 for ultrasound molecular imaging of VEGFR2 (KDR) in patients with cancer and chronic inflammatory diseases

主要目的：通过比较3种剂量的研究产品的增强效果，以免疫组化（IHC）作为金标准，在已知或疑似诊断为癌症（乳腺癌、甲状腺癌和卵巢癌）或慢性炎症性疾病（IBD和RA）的患者中，确定BR55用于超声成像评估血管生成区域的剂量。

[Translation]

Primary objective: To determine the dose of BR55 for ultrasound imaging assessment of angiogenic areas in patients with a known or suspected diagnosis of cancer (breast, thyroid, and ovarian cancer) or chronic inflammatory diseases (IBD and RA) by comparing the enhancing effects of 3 doses of the investigational product, using immunohistochemistry (IHC) as the gold standard.

Start Date30 Aug 2022

Sponsor / Collaborator

Bracco Imaging Medical Techologies (Shanghai) Co., Ltd.

[+2]

CTR20220971 / CompletedPhase 3

以腹腔镜染色通液术为金标准，评价声诺维用于子宫输卵管超声造影（HYCOSY）评估输卵管阻塞情况的诊断效能

[Translation] To evaluate the diagnostic efficacy of SonoVue for hysterosalpingography (HYCOSY) in assessing fallopian tube obstruction using laparoscopic dye perfusion as the gold standard

主要目的：使用腹腔镜染色通液术检查作为金标准，评价声诺维增强HyCoSy在评估女性不孕患者输卵管阻塞方面的敏感度和特异度。

[Translation]

Primary objective: To evaluate the sensitivity and specificity of SonoVue-enhanced HyCoSy in the assessment of fallopian tube obstruction in female infertility patients using laparoscopic dye perfusion examination as the gold standard.

Start Date11 Jul 2022

Sponsor / Collaborator

Bracco Imaging Medical Techologies (Shanghai) Co., Ltd.

[+2]

100 Clinical Results associated with Bracco Suisse SA

0 Patents (Medical) associated with Bracco Suisse SA

Literatures (Medical) associated with Bracco Suisse SA

01 Oct 2020·Investigative RadiologyQ1 · MEDICINE

Ultrasound Molecular Imaging With BR55, a Predictive Tool of Antiangiogenic Treatment Efficacy in a Chemo-Induced Mammary Tumor Model

Q1 · MEDICINE

Article

Author: Von Wronski, Mathew ; Botteron, Catherine ; Colevret, Delphine ; Tardy, Isabelle ; Helbert, Alexandre ; Padilla, Frederic ; Bettinger, Thierry ; Hyvelin, Jean-Marc

ObjectivesThe aim of this study was to evaluate the added value of ultrasound molecular imaging of the vascular growth factor receptor 2 (VEGFR2) expression, using the clinical grade contrast agent BR55, for the early evaluation of antiangiogenic treatment efficacy in a chemo-induced rat mammary tumor model.Materials and MethodsIn this preclinical study, chemo-induced rat mammary tumors were obtained after a single injection of N-nitroso-N-methylurea intraperitoneally in 46 prepubescent (age 38 ± 2 days) female rats. All experiments were performed under the authorization of the Direction Générale de la Santé, Geneva, Switzerland. Once tumor reached 0.8 cm in the largest cross-section, animals were enrolled in a sunitinib- or vehicle-treated group. Ultrasound molecular imaging was performed using BR55, a clinical grade targeted contrast agent against VEGFR2, before therapy and up to 72 hours. Anatomical changes of tumor over time, that is, area of the tumor largest cross-section and tumor volume, were measured in B-mode. Signal from microbubbles was detected in a nonlinear contrast mode (power modulation) using the iU22 diagnostic ultrasound system (Phillips, United States) equipped with a L12–5 linear transducer (transmit frequency 5 MHz). Peak enhancement and wash-in area under the curve were extracted from the time intensity curves generated by a dedicated quantification software for contrast ultrasound, so-called VueBox (Bracco Suisse SA, Switzerland). The signal of bound BR55 microbubbles in the tumor was quantified 10 minutes after injection. Altogether, these parameters were used to monitor tumoral response to treatment at the anatomical, functional, and molecular levels. At each time point, a cohort of tumors was harvested for the assessment of CD31 and VEGFR2 expression by immunohistochemistry staining.ResultsUnder sunitinib therapy, assessment of the expression of VEGFR2 by ultrasound molecular imaging with BR55 reveals a significant difference as early as 12 hours after first dosing (−25%), whereas tumor size significant change occurs only after 24 hours. At the end of the therapeutic protocol, 72 hours after the onset of treatment, molecular changes are more marked with a 80% decrease compared with only ~40% for the anatomic parameters. Ultrasound molecular imaging observations suggesting a decrease in VEGFR2 expression in treated tumors were corroborated by semiquantitative grading of VEGFR2, showing a decrease expression over time. Functional parameters measured in the perfusion phase also show a decrease along treatment, significant for 24 hours and of 48% of peak enhancement at the end of protocol.ConclusionsAnatomical, functional, and molecular evaluations are feasible in a single examination using BR55 ultrasound targeted contrast agent. Ultrasound molecular imaging of VEGFR2 can depict an early response to antiangiogenic treatment in a rat mammary tumor model. This imaging modality has a potential for early assessment of each patient's response, which could be useful to take decisions on therapeutic protocol, providing as such an imaging tool for personalized medicine.

01 Apr 2014·Investigative RadiologyQ1 · MEDICINE

Ultrasound Molecular Imaging of Transient Acute Myocardial Ischemia With a Clinically Translatable P- and E-Selectin Targeted Contrast Agent

Q1 · MEDICINE

Article

Author: Botteron, Catherine ; Bettinger, Thierry ; Hyvelin, Jean-Marc ; von Wronski, Mathew ; Tardy, Isabelle ; Nunn, Adrian ; Colevret, Delphine ; Bussat, Philippe ; Emmel, Patricia ; Tranquart, Francois ; Costa, Maria ; Frinking, Peter ; Lassus, Anne

OBJECTIVEThe diagnosis of acute coronary syndrome remains challenging especially in patients without clear symptoms or electrocardiographic and/or biomarker features. A hallmark of ischemia/reperfusion is activation of endothelial cells leading to altered expression of molecular markers, including selectins. In this context, we aimed to validate the value of ultrasound molecular imaging for detecting transient myocardial ischemia by using a clinically translatable dual P- and E-selectin-targeted ultrasound contrast agent (UCA) and microbubble (MB(selectin)).MATERIAL AND METHODSTransient (20 minutes) myocardial ischemia of rat heart was produced by ligation of the left anterior descending coronary artery ligation followed by 2-, 5-, or 24-hour reperfusion. Imaging of the transient ischemic event was achieved by the use of MB(selectin). Performance of this clinically translatable targeted UCA was compared with that of antibody-targeted streptavidin MBs. Finally, immunohistochemistry staining of rat myocardial ischemic tissue was performed to assess expression of selectins accessible to targeted UCA.RESULTSIn rats subjected to myocardial ischemia (20 minutes) followed by reperfusion (2 hours), injection of MB(selectin) produced high late phase (ie, 10-minute postinjection) ultrasound molecular imaging enhancement in the myocardium, which colocalized with the ischemic area. Late phase enhancement persisted 5 and 24 hours after reperfusion. Similarly, the use of MBP and MBE, comprising antibodies specific for P- and E-selectin, respectively, showed high late-phase enhancement within the ischemic area compared with remote myocardial tissue. Two and 5 hours after ischemia has resolved, a persistent expression of these 2 selectins was detected. After 24 hours of reperfusion, only MBE produced late phase enhancement within the ischemic myocardium. Immunohistochemical findings revealed that both P- and E-selectin were expressed and accessible on the surface of the activated endothelium 2 and 5 hours after the acute ischemic event, whereas only E-selectin remained accessible after 24 hours.CONCLUSIONSUltrasound molecular imaging of transient myocardial ischemia using dual selectin-targeted UCA is able to monitor the time course of expression of selectins after resolution of the ischemic event, paving the way for a large clinical diagnostic window.

01 Feb 2014·Clinical and Translational Imaging

Ultrasound and microbubbles for treatment purposes: mechanisms and results

Author: T. Bettinger ; F. Tranquart ; J. M. Hyvelin

The need to improve local drug and gene delivery, to increase their efficacy and safety, has prompted scientists to investigate different approaches. One of the most promising has been the combination of ultrasound and microbubbles, which can act as a local enhancer of this delivery. Even though the exact mechanism has not been fully elucidated, close contact between the bubbles and cell membrane is required to induce pore formation or endocytosis prior to secondary transfer of the molecule of interest into the cell. The literature contains a wealth of papers that have clearly demonstrated the efficiency of this approach in animal models. The clinical effectiveness of microbubble-mediated treatment demonstrated in sonothrombolysis will likely open up new treatment opportunities in refractory diseases or the possibility of developing new means of delivering molecules in poorly accessible tissues, such as brain tissue.

News (Medical) associated with Bracco Suisse SA

13 Apr 2023

·www.biospace.com

BRACCO IMAGING S.p.A. ANNOUNCES A NEW AGREEMENT WITH SONOTHERA™ TO EXPLORE THE EMERGING FIELD OF ULTRASOUND-GUIDED NONVIRAL GENE THERAPY

GENEVA, April 13, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., a global leader in diagnostic imaging, and SonoThera, Inc., a biotechnology company dedicated to treating the root cause of human diseases through genetic therapy, have entered into an agreement under which Bracco Imaging will provide its cutting-edge gas-filled microbubbles technology platform to SonoThera for use in the development of its novel, ultrasound-guided nonviral gene therapy platform. "We are delighted to have signed this new agreement with SonoThera," said Thierry Bettinger, Ph.D., Director of Bracco Research Center in Geneva. "The combination of Bracco's innovative gas microbubbles platform with SonoThera's ongoing development of a nonviral gene delivery platform will undoubtedly advance development in this novel approach to gene therapy." As part of this new agreement, Bracco Imaging will grant SonoThera a non-exclusive license to use Bracco's microbubble for Research purposes. "SonoThera is pleased to partner with a leader in microbubble development and commercialization such as Bracco," said Kenneth Greenberg, Ph.D., Co-Founder and Chief Executive Officer of SonoThera. "As we develop a new generation of genetic therapies, important collaborations such as this make it possible to find alternative pathways to viral vectors, potentially increasing safety and efficacy." The combination of ultrasound energy with microbubble allows transient permeability of vessel walls and cell membranes to enable the delivery of therapeutic nucleic acid payloads. The agreement will allow SonoThera to fully explore the potential of this innovative approach to facilitate the safe and effective delivery of various genetic materials to target cells/organs with minimal off-target delivery. Bracco Imaging is a ground-breaking player in the field of microbubbles. This is demonstrated by the worldwide marketing of contrast-enhanced ultrasound products and the ongoing research and development (R&D) programs to further exploit the potential of microbubbles for new applications in molecular imaging and therapy. To enable the translation of these new projects into products, significant investment has been brought to the site of Bracco Suisse SA in Geneva, particularly to increase the production capacity of these different agents. About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures, and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems, and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology dedicated to advancing next-generation targeted radiotherapeutics to treat patients who have cancer. Visit to learn more. About SonoThera™ Founded by Drs. Kenneth Greenberg, Michael Davidson, and Steve Feinstein, SonoThera, Inc. is a biotechnology company dedicated to treating the root cause of human disease through genetic therapy. SonoThera is developing an ultrasound-guided, nonviral gene therapy platform and treatments designed to provide patients with the next generation of safe and effective genetic medicines. The platform utilizes sonoporation, a microbubble-mediated biophysical process to non-invasively deliver genetic payloads selectively targeting a wide range of organs within the body. SonoThera is headquartered in South San Francisco, California. Visit to learn more. Micaela Colamasi PR Manager Bracco Imaging S.p.A. Email: micaela.colamasi@bracco.com Cell: +39 348 2314362

License out/inGene Therapy

100 Deals associated with Bracco Suisse SA

100 Translational Medicine associated with Bracco Suisse SA

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Sulfur Hexafluoride Lipid-Type A Microspheres	-	Phase 3
BR-55 ( VEGFR2 )	Neoplasms More	Phase 2

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