A Single Arm Open Label Study to Determine the Safety and Efficacy/Tolerability of Rhenium-186 NanoLiposomes (186RNL) for Recurrence of Glioma in Patients Who Received a Prior Treatment With 186RNL

This is an open-label, multicenter, Phase 1 study to establish the safety and efficacy/tolerability of a single dose of 186RNL by the intraventricular route (via intraventricular catheter) for recurrence glioma in patients who received a prior treatment of 186RNL.

开始日期2024-12-12

申办/合作机构

Plus Therapeutics, Inc.

NCT05034497

/ Active, not recruiting临床1期

A Multicenter Phase 1 Clinical Study to Determine the Maximum Tolerated Dose/Maximum Feasible Dose, Safety,& Efficacy of Single Dose Rhenium-186 NanoLiposome (186RNL) Administered Via Intraventricular Catheter for Leptomeningeal Metastases

This is an open-label Phase I clinical study that will administer a single dose of 186RNL via intraventricular catheter for treatment of Leptomeningeal Metastases (LM).

开始日期2021-12-06

申办/合作机构

Plus Therapeutics, Inc.

NCT01906385

/ Recruiting临床1/2期

A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)

This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.

开始日期2015-06-03

申办/合作机构

Plus Therapeutics, Inc.

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100 项与 Retreatment Rhenium Liposome 相关的临床结果

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100 项与 Retreatment Rhenium Liposome 相关的转化医学

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100 项与 Retreatment Rhenium Liposome 相关的专利（医药）

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项与 Retreatment Rhenium Liposome 相关的文献（医药）

2012-09-04·Molecular pharmaceutics2区 · 医学

Feasibility of Eradication of Breast Cancer Cells Remaining in Postlumpectomy Cavity and Draining Lymph Nodes following Intracavitary Injection of Radioactive Immunoliposomes

2区 · 医学

Article

作者: Phillips, William T. ; Li, Shihong ; Bao, Ande ; Goins, Beth ; Hrycushko, Brian A.

Most diagnosed early stage breast cancer cases are treated by lumpectomy and adjuvant radiation therapy, which significantly decreases the locoregional recurrence but causes inevitable toxicity to normal tissue. By using a technique of preparing liposomes carrying technetium-99m ((99m)Tc), rhenium-186 ((186)Re), or rhenium-188 ((188)Re) radionuclides, as well as chemotherapeutic agents, or their combination, for cancer therapy with real time image-monitoring of pharmacokinetics and prediction of therapy effect, this study investigated the potential of a novel targeted focal radiotherapy with low systemic toxicity using radioactive immunoliposomes to treat both the surgical cavity and draining lymph nodes in a rat breast cancer xenograft positive surgical margin model. Immunoliposomes modified with either panitumumab (anti-EGFR) or bevacizumab (anti-VEGF) were remote loaded with (99m)Tc diagnostic radionuclide, and injected into the surgical cavity of female nude rats with positive margins postlumpectomy. Locoregional retention and systemic distribution of (99m)Tc-immunoliposomes were investigated by nuclear imaging, stereofluorescent microscopic imaging, and gamma counting. Histopathological examination of excised draining lymph nodes was performed. The locoregional retention of (99m)Tc-immunoliposomes in each animal was influenced by the physiological characteristics of the surgical site of individual animals. Panitumumab- and bevacizumab-liposome groups had higher intracavitary retention compared with the control liposome groups. Draining lymph node uptake was influenced by both the intracavitary radioactivity retention level and metastasis status. The panitumumab-liposome group had higher accumulation on the residual tumor surface and in the metastatic lymph nodes. Radioactive liposomes that were cleared from the cavity were metabolized quickly and accumulated at low levels in vital organs. Therapeutic radionuclide-carrying specifically targeted panitumumab- and bevacizumab-liposomes have increased potential compared to non-antibody targeted liposomes for postlumpectomy focal therapy to eradicate remaining breast cancer cells inside the cavity and draining lymph nodes with low systemic toxicity.

2008-01-01·Journal of drug targeting3区 · 医学

Imaging of¹⁸⁶Re-liposome therapy in ovarian cancer xenograft model of peritoneal carcinomatosis

3区 · 医学

Article

作者: Bao, Ande ; McMahan, C. Alex ; Goins, Beth A. ; McManus, Linda M. ; Phillips, William T. ; Zavaleta, Cristina L.

This study determined the biodistribution of rhenium-186 ((186)Re) encapsulated in biotin-liposomes containing patent blue dye, injected intraperitoneally (IP) with avidin in an OVCAR-3 ovarian cancer xenograft model and evaluated tumor response of this therapy with fluorine-18-fluorodeoxyglucose ((18)F-FDG) microPET imaging. Treated rats (n = 8) received an IP injection of (186)Re-blue-biotin-liposomes (1000 MBq/kg) 30 min before an IP injection of avidin (5 mg), whereas control rats (n = 4) received a sham IP injection of saline. Scintigraphic images showed that (186)Re-blue-biotin liposomes/avidin were retained in the peritoneal cavity with 18% of the original activity remaining after 5 days. From 1 to 4 weeks post-treatment, peritoneal (18)F-FDG standard uptake values decreased 30% in treatment group, yet increased 44% in control group. Total number of cells in ascites was significantly higher in control versus treatment group. Omental fat in control rats had numerous tumor cells compared with treated rats. Results show the potential for (186)Re-blue-biotin-liposome/avidin system in treating advanced ovarian cancer involving peritoneal carcinomatosis.

JOURNAL OF NUCLEAR MEDICINE

¹⁸⁶Re-liposome labeling using ¹⁸⁶Re-SNS/S complexes: in vitro stability, imaging, and biodistribution in rats

作者: Phillips, William T. ; Goins, Beth ; Bao, Ande ; Negrete, George ; Klipper, Robert

Liposomes are important carriers for controlling the spatial and temporal distribution of drug mols. or other bioactive mols.Radiolabeled liposomes have potential applications in diagnostic imaging and radionuclide therapy.The purpose of this study was to develop a practical method for labeling liposomes with therapeutic rhenium radionuclides, using ¹⁸⁶Re as an example.Methods: An SNS pattern ligand, N,N-bis(2-mercaptoethyl)-N',N'-diethylethylenediamine (BMEDA), and an S pattern ligand, benzene thiol (BT), were used to make 2 kinds of ¹⁸⁶Re-SNS/S complexes, ¹⁸⁶Re-BMEDA and ¹⁸⁶Re-BMEDA + BT.These ¹⁸⁶Re-SNS/S complexes were mixed with neutral liposomes encapsulating cysteine or (NH₄)₂SO₄ to prepare ¹⁸⁶Re-liposomes.The in vitro labeling stability of ¹⁸⁶Re-liposomes was investigated by incubation in 50% fetal bovine serum/50% phosphate-buffered saline, pH 7.4, at 37°C.Rat distribution studies of ¹⁸⁶Re-liposomes after i.v. injection were also performed.Results: The labeling efficiencies of ¹⁸⁶Re-liposomes were 52.9%-81.3% depending on the ¹⁸⁶Re-SNS/S complex chosen and whether cysteine- or (NH₄)₂SO₄-encapsulated liposomes were used.¹⁸⁶Re-(NH₄)₂SO₄ liposomes labeled with ¹⁸⁶Re-BMEDA had the best in vitro labeling stability in serum with 89.8% ± 3.1% of the radioactivity associated with liposomes at 24 h and 76.2% ± 5.1% at 96 h.A specific activity of 1.85 GBq (50 mCi) of ¹⁸⁶Re per 50 mg of phospholipid could be achieved with good labeling stability.Biodistributions were followed for 72 h and showed good in vivo stability for ¹⁸⁶Re-liposomes that was characterized by a slow blood clearance and a gradually increasing spleen accumulation.¹⁸⁶Re-BMEDA alone had fast blood clearance and no accumulation in spleen.Conclusion: A practical method for labeling liposomes with ¹⁸⁶Re using ¹⁸⁶Re-SNS/S complexes is described.The labeled ¹⁸⁶Re-liposomes were stable in serum and in vivo and could potentially be useful for radionuclide therapy.

项与 Retreatment Rhenium Liposome 相关的新闻（医药）

2025-07-14

·医药观澜

5年生存率不足10%！打破脑癌"魔咒"，创新疗法“组合拳”有望带来新曙光

▎药明康德编者按：恶性脑肿瘤俗称“脑癌”，胶质母细胞瘤（GBM）是中枢神经系统最常见、最具侵袭性的恶性脑癌之一。因患者致死率高、生存期短，其被认为是“致命脑癌魔咒”。过去20多年，美国FDA批准了多款脑胶质瘤相关疗法，改善了部分患者的生存状况。为攻克GBM治疗挑战，当前全球有大量创新药物管线正在推进。作为医药创新的赋能者，药明康德依托一体化、端到端的CRDMO平台，也在持续助力全球合作伙伴，加速以GBM疗法为代表的突破性疗法更快走向病患。今年以来，胶质母细胞瘤（Glioblastoma Multiforme，GBM）新药研发领域迎来了一些新的进展，涉及小分子、多肽、细胞疗法等。这些最新研发进展，为GBM患者带来了新的曙光。GBM是成人中枢神经系统中最常见、且最具侵袭性的恶性肿瘤之一。其可怕的侵袭性在于，肿瘤细胞会像树根一样深入大脑组织，难以彻底清除。而且，作为中枢神经系统肿瘤，血脑屏障的存在也让许多药物难以到达病灶，使治疗效果大打折扣。目前，GBM的治疗方法包括手术、放疗、化疗以及新兴的靶向治疗和免疫疗法，如小分子靶向疗法、抗体靶向疗法等。尽管GBM治疗近年来有所进步，但由于其高度侵袭性、高复发率和治疗耐药性等，整体临床治疗仍面临严峻挑战。数据显示，GBM患者确诊后的中位总生存期仅12～15个月，五年生存率不足10%。图片来源：123RF上百条临床管线推进，形成多元化抗脑癌“组合拳”近年来，随着科学界对胶质母细胞瘤病理生物学认识的不断深入，全球涌现出更丰富的创新研发管线。据公开资料，目前全球针对GBM的临床在研项目超过200个，覆盖小分子、抗体药物、各类偶联药物、细胞和基因疗法、核酸药物以及多肽药物等多种治疗模式。在众多GBM临床管线中，小分子占据近半数比例。它们主要针对已在其他瘤种治疗领域得到验证的靶点，包括EGFR、CDK4/6、XPO1、FGFR、PARP等。上半年小分子领域有多项进展：例如，Kazia Therapeutics年初宣布正与FDA讨论其具血脑屏障穿透能力的PI3K/Akt/mTOR通路小分子抑制剂paxalisib在治疗新诊断GBM患者的潜在注册途径。该产品已在2/3期GBM临床研究中取得积极结果，达到总生存期的主要终点。再例如，百时美施贵宝从Mirati Therapeutics收购获得的PRMT5抑制剂MRTX1719（BMS-986504）于今年3月启动了针对MTAP基因缺失的复发性GBM患者的美国1期临床研究。与此同时，包括免疫检查点抑制剂在内的抗体疗法以及相关联合疗法，是GBM临床研究的重要探索方向。数据显示，当前有几十款抗体药物正在探索用于治疗GBM的潜力，涵盖了多种在其他癌种经过验证的靶点。比如Vaximm公司今年3月公布了口服抗VEGFR-2试验性疫苗VXM01联合抗PD-L1单抗avelumab治疗胶质母细胞瘤的2a期试验积极结果，支持其进一步的临床研究。细胞和基因疗法也是GBM在研管线的重要组成部分，涵盖了DC细胞疗法、NK细胞疗法、CAR-γδ T细胞药物等类型。上半年这一领域也取得多项进展。比如Genenta Science公布的Temferon长期随访数据显示，该疗法在治疗新确诊的具未甲基化MGMT基因启动子（uMGMT）的GBM患者中，两年生存率稳定维持在29%，中位总生存期保持17个月。这是一种通过将体外基因转到自体Tie2+造血干细胞/祖细胞（HSPC）中，利用肿瘤浸润的单核细胞/巨噬细胞，将免疫调节分子递送到肿瘤微环境中的疗法，从而重塑肿瘤免疫环境并激活持续性免疫应答。放射性疗法近年来在癌症治疗领域也大放异彩。Telix Pharmaceuticals在4月公布的TLX101 2期临床试验初步结果表明，这款靶向L型氨基酸转运蛋白1（LAT-1）的放射性药物可有效穿透血脑屏障并精准辐射癌细胞，且耐受性良好。Plus Therapeutics公司今年3月宣布，其放射治疗药物Rhenium（186Re）obisbemeda治疗胶质母细胞瘤的1期临床试验结果亮眼：接受大于100 Gy该药治疗的患者的中位总生存期（OS）为17个月，是接受标准治疗患者的中位OS（8个月）的两倍多。此外，其他创新疗法也取得突破性进展。Sapience Therapeutics公司于6月公布的lucicebtide（ST101）2期临床试验数据显示，该C/EBPβ拮抗剂多肽新药在新确诊和复发性GBM患者中均表现出良好的疾病控制效果，目前已获得FDA授予的快速通道资格。此外，Laminar Pharma于3月宣布其合成油酸衍生物LAM561在新诊断GBM患者的关键性2b/3期临床试验中取得积极结果，特别是在MGMT甲基化患者中显示出无进展生存期改善趋势。MimiVax公司2月份公布的SurVaxM 2b期临床试验中期分析结果显示，这款靶向survivin的肽模拟免疫原能够有效刺激患者自身免疫反应，在控制肿瘤生长和预防复发方面展现出良好潜力。产业合力攻克挑战，力争打破致命的“脑癌魔咒”当前，GBM的新药开发过程仍面临重重挑战。作为一种中枢神经系统肿瘤，难以穿透血脑屏障、肿瘤自身的免疫抑制、肿瘤异质性、复发耐药等等，均是GBM治疗需克服的难题。当下，业界正在探索多种新的治疗策略，比如通过创新递送技术突破血脑屏障，持续探索创新药物类型的潜力，通过联合疗法改变胶质瘤免疫抑制微环境或提高疗效等等。攻克挑战，需要全行业的共同努力。作为医药创新的赋能者，药明康德多年以来通过其一体化、端到端的CRDMO平台，为包括GBM在内的广泛疾病新药研发提供全方位的支持，助力全球合作伙伴加速突破性疗法面世，早日造福病患。以突破血脑屏障挑战为例，GBM作为中枢神经系统（CNS）肿瘤，血脑屏障是药物递送的一大障碍。许多药物难以穿透血脑屏障，到达肿瘤组织，导致治疗效果不佳。因此，业界正在持续探索各种新策略。在这一领域，公开信息显示，药明康德DMPK自2009年起开始进行CNS相关研究，拥有超过15年的临床前CNS药物研发经验，建立了针对CNS药物体外血脑屏障通透性评价的特色且准确性较高的“漏斗”模型。对于主要通过被动扩散入脑的CNS药物，“漏斗”模型的评估准确性为100%。通过完善的体外、体内测试平台，药明康德DMPK能够快速、准确、高效地对CNS药物进行全方位药代动力学相关评价，筛选出具有良好的脑通透性及稳定性的CNS候选药物。根据早前公开信息，该平台已完成包括常规小分子、治疗性蛋白、寡核苷酸等新分子实体类型项目百余项，成功助力全球客户多个CNS药物进入临床阶段。再例如，在GBM的研发管线中，也有一部分研究在探索靶向蛋白降解剂（TPD）的治疗潜力，其中包含分子胶和蛋白降解靶向嵌合体（PROTAC）分子管线。在这一新兴药物分子领域，药明康德也在持续助力全球合作伙伴加速创新分子的研发进程。公开信息显示，早在近10年前，在这项技术刚刚起步之时，药明康德就开始布局相关的能力和技术，积累了丰富的成功经验，搭建起集发现、合成、分析纯化和测试等能力的一体化赋能平台。目前，该平台已成功支持超过120款TPD分子的开发，其中20余款顺利推进至临床阶段。例如，近期发表的一项研究就报道了一种新型PROTAC分子优化策略，药明康德生物学平台为该研究成功构建了HiBiT细胞系，提供了PROTAC功能验证的细胞学检验方法，并充分验证了优化型PROTAC更强有力的IDO1降解效果，为药代动力学以及最大耐受量毒性分析奠定了基础。科学探索的脚步从未停歇。从手术、放化疗到近年来的多种新兴疗法，每一步进展都承载着为全球GBM患者带来新生的希望。随着基础研究的深入、新技术的迭代升级，以及产业界的合力，战胜“致命脑癌”是可期的。期待未来更多突破性疗法从实验室走向临床，为患者带来更多生的希望。参考资料:[1] Pouyan, A., Ghorbanlo, M., Eslami, M. et al. Glioblastoma multiforme: insights into pathogenesis, key signaling pathways, and therapeutic strategies. Mol Cancer 24, 58 (2025). https://doi-org.libproxy1.nus.edu.sg/10.1186/s12943-025-02267-0版权说明：本文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。转载授权或其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：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。

免疫疗法临床1期临床2期并购

2025-07-10

·GlobeNewswire-Health Care

Plus Therapeutics Announces Two CNSide Presentations at the Upcoming SNO/ASCO CNS Metastases Conference

The Joint Society for Neuro-Oncology (SNO) and the American Society of Clinical Oncology (ASCO) focus on the rapidly evolving area of central nervous system metastases Presentations will highlight the clinical utility of the company’s CNSide Cerebrospinal Fluid (CSF) Assay Platform for patients at risk for central nervous system metastases HOUSTON, July 10, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced that its wholly-owned subsidiary, CNSide Diagnostics, LLC (“CNSide”) will be showcasing two presentations at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The CNSide data highlights its ability to quantify tumor cells and deliver actionable insights,” said Michael Rosol, Ph.D., Plus Therapeutics’ Chief Development Officer. “The diagnostic assay is an exciting advancement for enhancing CNS metastases management and driving therapies like REYOBIQ™ in our ReSPECT-LM dose optimization trial." Presentations: TitleCSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker Assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (BIOM-04), (FORESEE Study, NCT05414123) PresenterPriya Kumthekar, M.D. Date/TimeThursday, August 14, 2025, 7:15 – 9:00 p.m. ET LocationGrand Ballroom VI TitleThe Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor, (BIOM-03) PresenterPriya Kumthekar, M.D. Date/TimeFriday, August 15, 2025, 3:25 – 4:50 p.m. ET LocationGrand Ballroom I-V About CNSide Diagnostic, LLC CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases. About LMLeptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies. About Plus TherapeuticsHeadquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com. Forward-Looking StatementsThis press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect,” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the potential market for the CNSide CSF Assay, the timing in which the CNSide CSF Assay is commercially launched and commercialization is expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; risks related to a halt in trading or delisting of the Company’s common stock on Nasdaq; Medicare and private payors may not provide coverage and reimbursement or may breach, rescind or modify their contracts or reimbursement policies or delay payments; the risk that our products and services may not perform as expected; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so. Investor ContactCORE IRinvestor@plustherapeutics.com

ASCO会议放射疗法

2025-07-08

·GlobeNewswire-Health Care

Plus Therapeutics Announces Initial Patients Successfully Treated in ReSPECT-LM Dose Optimization Trial for REYOBIQ™ in Leptomeningeal Metastases

Substantial clinical need expected to facilitate rapid overall trial enrollmentHOUSTON, July 08, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced the treatment of its initial patients in the Company’s ReSPECT-LM dose optimization trial for REYOBIQTM (rhenium Re186 obisbemeda) for the treatment of leptomeningeal metastases (LM). The dose optimization trial builds on promising results from the Company’s completed Phase 1 single-dose escalation study, which demonstrated the feasibility of REYOBIQ for treating LM. The trial is designed in alignment with the FDA’s Project Optimus to identify the optimal dosing regimen that maximizes efficacy and safety. “Based on the promising, recently completed Phase 1 single-dose escalation study and lack of FDA approved therapies for LM, we expect trial enrollment to proceed rapidly in accordance with the trial protocol,” said Andrew Brenner, M.D., Ph.D., Professor-Research, Departments of Medicine, Neurology, and Neurosurgery & S & B Kolitz/CTRC-Zachry Endowed Chair Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio. “Furthermore, assuming REYOBIQ continues its attractive safety profile, we expect that we will enroll all required patients and doses in Cohort 1 by the end of this year.” Patients and family members interested in enrolling in the ReSPECT-LM Dose Optimization Trial can learn more here. ReSPECT-LM Dose Optimization TrialThe study aims to optimize treatment dosing for maximum efficacy and safety, with the primary objectives of determining the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter at defined intervals in patients with LM from any primary solid tumor cancer, and to identify both the maximum tolerated dose and minimum effective dose. Previously announced details of the study, including primary, secondary, and exploratory endpoints, can be found here. The dose optimization study builds on encouraging results from the Company’s previously announced Phase 1 trial, which showed a single dose of REYOBIQ delivered up to an average absorbed dose of >250 Gy to the cranial subarachnoid space. It also demonstrated that 5 of 7 patients achieving an over 80% reduction in LM tumor cells in the cerebrospinal fluid survived at least one year post-treatment. Additional details can be found here. The Company anticipates presenting these data and additional information from the completed single-dose escalation trial at the upcoming SNO/ASCO CNS Metastases Conference on August 14-16, 2025, in Baltimore, MD. The company will also request an End of Phase 1 Type B meeting with the FDA to align on the clinical development plan and the design of a potential registrational trial. The ReSPECT-LM dose optimization trial benefits from a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT), the second largest public funding source for cancer research in the world. About LMLeptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies. About REYOBIQ™ (rhenium Re186 obisbemeda)REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program. About Cancer Prevention & Research Institute of Texas (CPRIT)The Cancer Prevention & Research Institute of Texas (CPRIT) is a $6 billion cancer research and prevention initiative legislated in Texas. CPRIT accepts applications and award grants for a wide variety of innovative cancer-related research and product development and for the delivery of evidence-based cancer prevention programs and services by public and private entities located in Texas. CPRIT is the largest state cancer research investment in the history of the United States and the second largest cancer research and prevention program in the world with a three-part mission, established by the Texas Legislature, to invest in the research prowess of Texas universities and research organizations; create and expand life science infrastructure across the state; and expedite innovation in research and enhance the potential of breakthroughs in prevention and cures. About Plus TherapeuticsHeadquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM), recurrent glioblastoma (GBM), and pediatric brain cancer (PBC). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://plustherapeutics.com/ or contact info@plustherapeutics.com. Forward-Looking StatementsThis press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding statements regarding the potential promise of REYOBIQ™, expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates; the Company’s clinical trials, including statements regarding the timing and characteristics of the ReSPECT-LM single dose and multi-dose clinical trials. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; risks related to a halt in trading or delisting of the Company’s common stock on Nasdaq; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics’ business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics’ annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so. Investor ContactCORE IRinvestor@plustherapeutics.com

临床1期临床结果放射疗法

100 项与 Retreatment Rhenium Liposome 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
脑膜肿瘤	临床2期	-	Plus Therapeutics, Inc.	2023-10-10
复发性胶质瘤	临床2期	美国	Plus Therapeutics, Inc.	2015-06-03
复发性胶质母细胞瘤	临床2期	-	Plus Therapeutics, Inc.	-
家族性室管膜瘤	临床1期	-	Plus Therapeutics, Inc.	2025-09-01
高级别胶质瘤	临床1期	-	Plus Therapeutics, Inc.	2025-09-01
软脑膜转移性恶性肿瘤	临床1期	美国	Plus Therapeutics, Inc.	2021-12-06
中枢神经系统肿瘤	临床阶段不明	美国	Piramal Pharma Solutions, Inc.	-
室管膜瘤	临床申请批准	美国	Plus Therapeutics, Inc.	2025-06-25

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05034497 (ReSPECT-LM, GlobeNewswire) 人工标引	临床1期	软脑膜转移性恶性肿瘤	20	Rhenium (186Re) Obisbemeda	構獵餘築壓艱齋選鬱夢(遞繭獵鹽鑰襯鬱繭鑰觸) = 1 dose-limiting toxicity (thrombocytopenia) observed in Cohort 5. 網範廠淵壓夢構觸觸遞 (鏇窪夢範遞膚積簾鏇網 )	积极	2024-11-25
NCT05034497 (ReSPECT-LM, GlobeNewswire) 人工标引	临床1期	软脑膜转移性恶性肿瘤	16	Rhenium (186Re) Obisbemeda	餘淵廠艱窪齋獵衊簾選(鹹餘願範醖齋壓鹽製網) = 糧衊艱繭網網觸窪糧簾製積膚窪顧廠淵蓋淵鏇 (範醖膚繭壓鹹壓製鬱鑰 ) 更多	积极	2024-08-12
NCT01906385 (ReSPECT-GBM, Corporate Publications) 人工标引	临床1/2期	复发性胶质母细胞瘤	15	186RNL	願築繭鑰齋蓋膚遞積鏇(艱鹽築觸餘構範憲艱鑰) = 簾繭繭簾蓋膚醖鑰繭膚積繭鬱鹽選網遞壓餘築 (衊鹽膚遞餘艱製構鹽鏇 ) 更多	积极	2023-11-20
RESPECT-GBM (SNO2023)	临床1/2期	复发性胶质瘤	27	Rhenium-186 Nanoliposome (186RNL) (186RNL dose <100 Gy)	壓網簾窪網網製簾願齋(餘醖衊膚鹹壓衊範壓鏇) = weakness, fatigue, headache, seizure, scalp discomfort after CED 廠範憲糧艱壓蓋憲壓淵 (願膚壓遞願襯鏇觸網構 )	积极	2023-11-10
RESPECT-GBM (SNO2023)	临床1/2期	复发性胶质瘤	27	Rhenium-186 Nanoliposome (186RNL) (186RNL dose ≥100 Gy)		积极	2023-11-10
NCT01906385 (SNMMI2023)	临床1/2期	复发性胶质瘤	-	186RNL (Rhenium-186 Nanoliposome)	襯顧夢膚淵簾遞鹹廠遞(築鹹淵願夢鑰繭醖糧憲) = Most AEs were mild or moderate (Grade 1 or 2) and non-serious. In general, AEs were deemed by the principal investigator to be unrelated to treatment, with exception to 1 case of scalp discomfort considered related to the surgical procedure and 1 case of cerebral edema considered possibly related to ¹⁸⁶RNL and/or tapering of oral corticosteroids 獵繭鏇鏇衊鏇鹽蓋範範 (鹹遞夢遞鏇顧糧選膚衊 )	-	2023-08-28
NCT05034497 (SNMMI2023)	临床1期	软脑膜转移性恶性肿瘤	-	186RNL (Rhenium-186 Nanoliposome)	願構鹹鹹鹹夢築鑰淵餘(鑰醖遞鹽繭醖襯鏇製餘) = the most common AE was headache 選鹽憲壓餘繭構餘鬱襯 (窪廠窪願憲鬱襯襯選獵 )	-	2023-08-28
NCT05034497 (ReSPECT-LM, NEWS) 人工标引	临床1/2期	脑膜肿瘤	10	186RNL	觸鬱襯鹽鹽製鑰壓膚艱(衊餘製艱築鏇願壓鑰膚) = 簾淵構夢艱窪廠觸鬱鏇廠憲製積顧願鹹膚觸選 (憲鏇齋餘壓衊窪觸壓簾 ) 更多	积极	2023-08-11
NCT01906385 (Corporate Publications) 人工标引	临床1/2期	高级别胶质瘤 \| 家族性室管膜瘤	23	190RNL (Gy＜100)	廠鬱簾餘獵鏇選獵餘壓(鏇壓醖醖鏇獵鬱願簾積) = The AE’s with the highest incidence included fatigue (50%), muscular weakness (33.3%), headache (33.3%), and gait disturbance (27.8%) 顧願餘簾獵憲淵選簾網 (鹹築鏇膚簾襯選艱簾醖 )	积极	2022-11-21
NCT01906385 (Corporate Publications) 人工标引	临床1/2期	高级别胶质瘤 \| 家族性室管膜瘤	23	190RNL (Gy＞100)		积极	2022-11-21
NCT05034497 (ReSPECT-LM, Corporate Publications) 人工标引	临床1期	脑膜白血病	4	186RNL	鏇鹽襯衊選醖積淵觸壓(鹽遞壓壓壓醖顧憲衊鑰) = 鏇鏇廠觸築襯網繭衊觸網範夢觸鹽構憲鹹選選 (鏇糧獵衊簾鹹夢構糧艱 )	积极	2022-10-19
ReSPECT™ (EANM2022)	临床1/2期	复发性胶质瘤	-	Rhenium-186 NanoLiposome (186RNL)	衊壓鬱憲鹽衊憲獵壓齋(獵餘壓蓋遞製築鑰積齋) = one grade 3 treatment related adverse event (AEs) 觸壓獵鬱鏇餘淵鬱窪簾 (憲蓋廠壓簾鹽網廠積憲 ) 更多	积极	2022-09-22
ReSPECT™ (EANM2022)	临床1/2期	复发性胶质瘤	-	Bevacizumab		积极	2022-09-22