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MONROE TOWNSHIP, N.J. & OXFORD, England--(BUSINESS WIRE)-- Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced highlights from clinical studies conducted by its collaborators at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, June 8-11, 2024. They included interim results of a study by Emory University that evaluated POSLUMA® (flotufolastat F 18) injection PET/CT with and without furosemide in men with biochemically recurrent prostate cancer (BCR), as well as results of a retrospective study conducted by the Technical University of Munich (TUM) that evaluated qualitative and quantitative PET parameters in urinary activity and tumor uptake for 18F-flotufolastat and 68Ga-PSMA-11 in primary prostate cancer. The studies build upon a recently published post-hoc analysis of Blue Earth Diagnostics’ clinical studies in which POSLUMA demonstrated low urinary bladder interference that did not impact disease assessment in the vast majority of patients1. Links to the abstracts follow below. POSLUMA is approved and indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. 18F-Flotufolastat produced at TUM is an investigational agent for which the safety and efficacy have not been established by the U.S. Food and Drug Administration. “The ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” said Eugene Teoh, MBBS, MRCP, FRCR, D.Phil., Chief Medical Officer of Blue Earth Diagnostics. “Activity in the urinary tract, especially in the urinary bladder, is a common feature of FDA-approved PSMA-PET radiopharmaceuticals which are excreted via the urine. High urinary activity can potentially obscure tumors in the prostate region and regional lymph nodes in the pelvis, which are common sites of recurrence, and interfere with accurate image interpretation.” Dr. Teoh continued, “These results reported at SNMMI support our previous experience with POSLUMA and are broadly consistent with results from our clinical trials. A post-hoc analysis of our Phase 3 clinical trials demonstrated that 96% of patients (682/712) exhibited either no urinary activity or activity that was easily distinguishable from disease1. Although furosemide usage has been widely described for other PSMA PET imaging agents as a potential means to reduce urinary activity, the POSLUMA Phase 3 trial results were achieved without its use. In cases from this Emory study where furosemide was not used, results also demonstrate the high POSLUMA detection rates in patients with low PSA levels as observed in prior Blue Earth Diagnostics clinical trials.” “These findings from Emory and TUM reinforce important clinical considerations in selecting a precision diagnostic imaging agent for PSMA-PET procedures,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “POSLUMA provides physicians with useful information based on its performance at low PSA levels, PSMA binding and low urinary bladder activity. It is included in nationally recognized clinical oncology guidelines for prostate cancer and covered by the vast majority of insurance plans. Labeled with the radioisotope fluorine-18 (18F) to leverage high image quality, POSLUMA is widely available through the network of our commercial U.S. manufacturer and distributor, PETNET Solutions Inc, A Siemens Healthineers Company.” Highlights of the Abstracts Impact of forced diuresis with furosemide in the evaluation of biochemical recurrence of prostate cancer with 18F-rhPSMA 7.3 PET/CT: Interim analysis of an ongoing prospective trial Interim results from a prospective study were presented by Ismaheel Lawal, MD, PhD, Resident Physician, Department of Radiology and Imaging Sciences, Emory University, Atlanta Ga. The study investigated the impact of forced diuresis with furosemide during 18F-flotufolastat PET/CT imaging for further improved bladder activity and prostate bed region recurrence detection in BCR. Twelve men had completed both with- and without-furosemide PET/CT scans at the time of the interim analysis. The study assessed bladder activity by SUV, patient-level recurrence and recurrence in the prostate-bed region. The authors concluded that furosemide-augmented bladder activity reduction showed no safety issues and was feasible for 18F-flotufolastat PET/CT imaging. While recognizing detection rates without furosemide remain high and consistent with Phase 3 studies, recurrence detection may be enhanced with the use of furosemide, by further decreasing observed urinary activity, and with no impact on the radiotracer avidity in the recurrent lesion. The full abstract is available here. Evaluation of qualitative and quantitative PET parameters in primary prostate cancer patients: double-match comparison of 18F-flotufolastat- and 68Ga-PSMA-11-PET Results from a retrospective study were presented by Isabel Rauscher, MD, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany. The study evaluated qualitative and quantitative PET parameters in urinary activity and tumor uptake for 18F-flotufolastat and 68Ga-PSMA-11 in a matched cohort of 62 patients staged for primary prostate cancer. Parameters included overall interference from bladder activity, scoring of median semi-quantitative bladder activity, presence of ureteral retention and halo artifacts, and tumor-to-bladder uptake ratio. The authors concluded that interpretation of 68Ga-PSMA-11 PET was significantly more impacted by bladder activity than 18F-flotufolastat PET in the matched populations of primary prostate cancer patients. The full abstract is available here. Indication and Important Safety Information About POSLUMA INDICATION POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or . Full POSLUMA prescribing information is available at . About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: . 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 vehicle to develop radiopharmaceutical therapies. Visit: . 1Kuo PH, Hermsen R, Penny R, Postem EJ. Post-hoc analysis of the LIGHTHOUSE and SPOTLIGHT studies to assess the impact of urinary activity on interpretation of 18F-rhPSMA-7.3 PET/CT. Mol Imaging Biol. 2024 Feb;26(1):53-60. doi: 10.1007/s11307-023-01867-w. POSLUMA is a registered trademark of Blue Earth Diagnostics Ltd. PP-rh-US-0499 This press release is for U.S. audiences only View source version on businesswire.com: Contacts For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice President, Corporate Communications (M) (781) 799-7917 priscilla.harlan@blueearthdx.com For Blue Earth Diagnostics (UK) Clare Gidley Associate Director Marketing and Communications Tel: +44 (0) 7917 536939 clare.gidley@blueearthdx.com Media Mike Beyer (M) (312) 961-2502 mikebeyer@sambrown.com Source: Blue Earth Diagnostics View this news release online at:

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 6月5日，专注于放射性核素偶联药物（RDC）领域的生物制药公司Telix Pharmaceuticals披露了首次公开募股（IPO）的条款，计划在纳斯达克上市。Telix计划以每股11.87美元的价格发行1700万股股票，IPO金额约2.02亿美元。 Telix表示，预计此次发行的净收益将达到1.83亿美元，如果承销商行使其全部期权购买额外股票，则净收益将达到2.11亿美元。 药融云数据www.pharnexcloud.com显示：Telix Pharmaceuticals是一家成立于2015年，总部位于澳大利亚墨尔本的生物制药公司，主要专注于诊断和治疗放射性药物的开发和商业化，在比利时、日本、瑞士和美国均设有国际业务。Telix Pharmaceuticals的技术使用靶向辐射成像和治疗相结合，有可能改变临床医生发现和治疗癌症和罕见疾病的方式，更好地为治疗决策提供信息，并为患者提供真正的个性化治疗。2017年11月，Telix Pharmaceuticals上市市值还不到4000万美元，截至2024年6月5日，公司市值61亿澳元（近40亿美元），上涨100倍！ Telix有两种已获批准的放射性同位素诊断方法，另有两款待获批产品。该公司还在开发放射性疗法，其中两种用于前列腺癌，一种用于肾癌，另一种用于胶质母细胞瘤(一种侵袭性脑癌)。其主要的前列腺癌候选药物（177Lu-TLX591）目前正在进行三期试验，预计将在2025年上半年披露中期数据。 公司在研管线（来源：公司官网） 据披露信息，Telix2024年第一季度总收入为1.15亿澳元（7600万美元），同比增长84%；来自客户的收入为1.75亿澳元（1.16美元），同比增长73%，这一增长是由于与2023年第一季度相比，Telix 的主要前列腺癌成像产品Illuccix在2024年第一季度在美国的商业销售额增加了78.4%。商业销售额的增长主要是由不断扩大的PSMA-PET成像市场和大型医院客户的增加所推动的。截至2024年3月31日，公司拥有现金及现金等价物1.227亿澳元（8100万美元）。 总结 核药一直被认为是一条有巨大潜力的赛道，核药研发企业也可谓是众星云集。除了海外市场的阿斯利康、百时美施贵宝、诺华和礼来等，国内市场的中国同辐、东诚药业、远大医药和「医药一哥」恒瑞医药等也在积极布局核药领域，并有多款产品处于临床阶段。随着企业的积极布局，我们相信国产核药今年也将实现突破。 活动推荐 点击图片查看详细信息