The objective of this program is to provide GaM for compassionate use in patients with relapsed/refractory histologic or molecular glioblastoma who have exhausted available treatments.
The population of this program is adult patients aged greater than or equal to 18 years with a diagnosis of relapsed/refractory histologic or molecular glioblastoma, according to the WHO 2021 diagnostic criteria.
Molecular glioblastoma is characterized as an IDH-wildtype diffuse and astrocytic glioma in adults if there is microvascular proliferation or necrosis or TERT promoter mutation or EGFR gene amplification or +7/-10 chromosome copy number changes

开始日期-

申办/合作机构

Imaging Biometrics LLC

[+1]

NCT04319276 / Recruiting临床1期IIT

A Phase 1 Clinical Trial of Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

This is a phase 1 investigational study to assess the safety and preliminary efficacy of oral gallium maltolate (GaM) in participants with relapsed glioblastoma (GBM).

开始日期2022-11-11

申办/合作机构

Medical College of Wisconsin

NCT00050687 / Terminated临床1/2期

A Randomized, Serum Level-targeted Study Investigating the Safety and Pharmacokinetics of Orally Administered Gallium Maltolate in Patients With Various Refractory Malignancies

This study will test the safety, tolerance, and efficacy of different doses of oral gallium maltolate. Patients will receive oral gallium maltolate twice daily for 28-consecutive days followed by 14 days off treatment. This dosing cycle will be repeated. Adverse effects will be assessed and the levels of gallium in serum will be measured. Any effect of the drug on the cancer and any improvement in cancer-related symptoms will also be measured.

开始日期2001-06-01

申办/合作机构

Titan Pharmaceuticals, Inc.

100 项与麦芽酚镓相关的临床结果

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100 项与麦芽酚镓相关的专利（医药）

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项与麦芽酚镓相关的文献（医药）

2024-12-01·Bioactive Materials

Antimicrobial hydrogel foam dressing with controlled release of gallium maltolate for infection control in chronic wounds

Article

作者: Ang, Nicolai ; Bryan, Laura ; Richardson, Lauren ; Guo, Leopold ; Lan, Ziyang ; Welch, Shannara ; Fletcher, Alan ; Whitfield-Cargile, Canaan ; Cosgriff-Hernandez, Elizabeth

Effective treatment of infection in chronic wounds is critical to improve patient outcomes and prevent severe complications, including systemic infections, increased morbidity, and amputations. Current treatments, including antibiotic administration and antimicrobial dressings, are challenged by the increasing prevalence of antibiotic resistance and patients' sensitivity to the delivered agents. Previous studies have demonstrated the potential of a new antimicrobial agent, Gallium maltolate (GaM); however, the high burst release from the GaM-loaded hydrogel gauze required frequent dressing changes. To address this need, we developed a hydrogel foam-based wound dressing with GaM-loaded microspheres for sustained infection control. First, the minimal inhibitory and bactericidal concentrations (MIC and MBC) of GaM against two Staphylococcus aureus strains isolated from chronic wounds were identified. No significant adverse effects of GaM on dermal fibroblasts were shown at the MIC, indicating an acceptable selectivity index. For the sustained release of GaM, electrospraying was employed to fabricate microspheres with different release kinetics. Systematic investigation of loading and microsphere size on release kinetics indicated that the larger microsphere size and lower GaM loading resulted in a sustained GaM release profile over the target 5 days. Evaluation of the GaM-loaded hydrogel dressing demonstrated cytocompatibility and antibacterial activities with a zone of inhibition test. An equine distal limb wound model was developed and utilized to demonstrate the efficacy of GaM-loaded hydrogel foam in vivo. This antimicrobial hydrogel foam dressing displayed the potential to combat methicillin-resistant S. aureus (MRSA) infection with controlled GaM release to improve chronic wound healing.

2024-04-01·Acta Tropica

Gallium maltolate, a promising low toxicity drug with curative effect on mice chronically infected with Trypanosoma evansi

Article

作者: Chaúque, Beni Jequicene Mussengue ; Grando, Thirssa Helena ; Oliveira, Camila Belmonte ; Gressler, Lucas Trevisan ; Rosa, Luciana Dalla ; Bottari, Nathieli ; Monteiro, Silvia Gonzalez

Trypanosoma evansi is a flagellate protozoan that infects a wide range of hosts, especially horses. Clinically, the infection is characterized by rapid weight loss, anemia and mobility disorders. This study evaluated the efficacy of treatment gallium maltolate (GaM) in rats infected with T. evansi in the acute and chronic phases of the disease and its influence on the enzyme and blood parameters. 48 animals (Rattus norvegicus) were divided into 8 groups (A-H) of 6 animals each, namely: A: (negative control) uninfected; B: acutely infected positive control; C: chronically infected positive control; D: acutely infected, treated with GaM for 7 days post infection (p.i.); E: acutely infected treated with GaM for 3 days before infection (b.i) and 7 days p.i.; F: chronically infected, treated with GaM for 7 days p.i.; G: chronically infected, treated with GaM for 3 days b.i. and 7 days p.i.; and H: uninfected treated with GaM for 10 days. Acute infected animals (B, D and E) had a progressive increase in parasitemia and were died or euthanized before completing treatment days (5th days p.i.) as they had high parasitemia (over 100 field trypanosomes in the blood smear). Thus, it can be concluded that GaM was not effective against an acute infection. In untreated chronically infected animals (C) the parasitemia also increased progressively and they were euthanized on the 7th day p.i.. The chronically infected and treated animals (F and G) showed low parasitemia and after treatment became negative, showing no trypanosomes in the bloodstream until the 50th day of the experiment. Thus, we conclude that GaM was effective against chronic infections. In uninfected and treated animals (H) hematological, biochemical and enzymatic parameters had no significant changes when compared to the negative control group (A) demonstrating the low toxicity of GaM.

2023-08-01·Cellular Oncology

Gallium maltolate shows synergism with cisplatin and activates nucleolar stress and ferroptosis in human breast carcinoma cells

Article

作者: Lo, Kai-Yin ; Chen, Chieh-Hsin ; Huang, Yi-Ming ; Yang, Ya-Wen ; Grillet, Louis ; Hsieh, Yu-Chen

PURPOSEBreast cancer is the most common cancer in women. Triple-negative breast cancer (TNBC) is an aggressive disease with poor outcomes. TNBC lacks effective targeted treatments, and the development of drug resistance limits the effectiveness of chemotherapy. It is crucial to identify new drugs that can enhance the efficacy of traditional chemotherapy to reduce drug resistance and side effects.METHODSTNBC cell lines, MDA-MB-231 and Hs 578T, and a normal cell line, MCF-10 A, were included in this study. The cells were treated with gallium maltolate (GaM), and their transcriptome was analyzed. Ferroptosis and nucleolar stress markers were detected by qPCR, western blotting, fluorescence microscopy, and flow cytometry. The impairment of ribosome synthesis was evaluated by northern blotting and sucrose gradients.RESULTSGaM triggered cell death via apoptosis and ferroptosis. In addition, GaM impaired translation and activated nucleolar stress. Cisplatin (DDP) is a chemotherapeutic agent for advanced breast cancer. While single treatment with GaM or DDP at low concentrations did not impact cell growth, co-administration enhanced cell death in TNBC but not in normal breast cells. The enhancement of ferroptosis and nucleolar stress could be observed in TNBC cell lines after co-treatment.CONCLUSIONSThese results suggest that GaM synergizes with cisplatin via activation of nucleolar stress and ferroptosis in human breast carcinoma cells. GaM is marginally toxic to normal cells but impairs the growth of TNBC cell lines. Thus, GaM has the potential to be used as a therapeutic agent against TNBC.

项与麦芽酚镓相关的新闻（医药）

2024-10-29

·生物谷

Bioact Mater：控释麦芽糖酸镓抗菌水凝胶泡沫敷料用于慢性伤口感染控制

该研究揭示控释麦芽糖酸镓抗菌水凝胶泡沫敷料用于慢性伤口感染控制。慢性伤口已成为世界范围内日益严重的医疗保健问题，其挑战之一是由细菌或其他微生物定植引起的伤口感染。在慢性伤口中，皮肤物理屏障的长期破坏伴随着局部蛋白质、聚糖和脂质的变性，为细菌粘附和生长提供了一个营养丰富的环境。细菌感染在持续炎症阶段阻滞了伤口愈合，显著延缓了慢性伤口的结构重建和功能恢复。此外，感染引起的伤口恶化和坏死可能导致下肢截肢或严重的慢性伤口并发症，包括全身性败血症。细菌感染和生物膜的形成诱导了伤口部位的持续炎症，导致活性氧(ROS)和基质金属蛋白酶(MMPs)的过量产生。升高的氧化应激和高浓度的蛋白水解酶会阻碍细胞生长、细胞外基质重建和顺序血管生成，从而大大延迟伤口愈合。因此，需要有效控制感染的一线创面敷料来实现慢性伤口的加速和改善愈合。目前减轻慢性伤口细菌感染的方法包括使用一种或多种抗菌剂，使用智能生物材料刺激ROS和MMPs的受控产生，以及设计具有定制纳米结构的生物材料，以实现靶向免疫调节和抗污染活性。在此，研究者研究了一种新的抗菌剂，麦芽糖酸镓(GaM)，以对抗慢性伤口感染，因为它显示出较少的细菌耐药性发展的机会，促进局部和全身用药，并有可能促进伤口愈合。GaM在水和脂质中都具有高溶解度，这有利于其在不同介质中的运输，并干扰铁依赖性代谢活动，如基因表达和DNA复制。图片来源：https://doi.org/10.1016/j.bioactmat.2024.08.044 近日，来自美国德克萨斯大学的研究者们在Bioact Mater杂志上发表了题为“Antimicrobial hydrogel foam dressing with controlled release of gallium maltolate for infection control in chronic wounds”的文章，该研究揭示控释麦芽糖酸镓抗菌水凝胶泡沫敷料用于慢性伤口感染控制。慢性伤口感染的有效治疗对于改善患者预后和预防严重并发症(包括全身性感染、发病率增加和截肢)至关重要。目前的治疗方法，包括抗生素给药和抗菌敷料，受到日益普遍的抗生素耐药性和患者对所给药物的敏感性的挑战。先前的研究已经证明了一种新的抗菌剂——麦芽糖酸镓(GaM)的潜力;然而，高爆裂释放从GaMloaded水凝胶纱布需要经常更换敷料。为了满足这一需求，研究者开发了一种基于水凝胶泡沫的伤口敷料，其中含有gam微球，用于持续感染控制。电喷涂制备GaM负载PLGA微球示意图及微球粒径和GaM负载比的调制图片来源：https://doi.org/10.1016/j.bioactmat.2024.08.044 首先，研究者确定了GaM对两株慢性伤口金黄色葡萄球菌的最小抑菌浓度(MIC和MBC)。MIC未显示GaM对真皮成纤维细胞的显著不良反应，表明选择性指数可接受。为了实现GaM的缓释，采用电喷涂法制备了具有不同释放动力学的微球。系统研究了微球的装载量和微球尺寸对释放动力学的影响，结果表明，微球尺寸越大，GaM的装载量越小，GaM的释放时间越长。通过抑制区试验，对负载gam的水凝胶敷料的细胞相容性和抗菌活性进行了评价。建立了马远端肢体伤口模型，并利用该模型在体内验证了gam负载水凝胶泡沫的有效性。这种抗菌水凝胶泡沫敷料显示出对抗耐甲氧西林金黄色葡萄球菌(MRSA)感染的潜力，并控制GaM的释放，以改善慢性伤口愈合。建立马远端肢体模型和具有代表性的创面照片图片来源：https://doi.org/10.1016/j.bioactmat.2024.08.044 综上所述，研究者成功地在多孔水凝胶泡沫中加入了负载gam的微球，制成了负载gam的抗菌水凝胶泡沫。微球大小、GaM负载和微球浓度调节了GaM的释放曲线，以满足敷料应用期间持续抑制细菌的要求。体外实验表明，含gam的水凝胶泡沫没有细胞毒性，并证实了其抗菌活性。体内研究评估了这种gam负载水凝胶泡沫在新型伤口愈合模型中的功效，并证明了与作者体外研究一致的积极作用。保留水分平衡控制维持的功能，抗菌水凝胶泡沫敷料抑制细菌感染。进一步的研究可能会集中在更全面的评估细菌对GaM的耐药性和这种抗菌敷料的体内疗效上。尽管如此，这种抗菌水凝胶泡沫敷料已被证实是一种有效的候选物，可以控制细菌感染，加速感染慢性伤口的愈合，预防蜂窝织炎或败血症。(生物谷 Bioon.com）参考文献 Ziyang Lan et al. Antimicrobial hydrogel foam dressing with controlled release of gallium maltolate for infection control in chronic wounds. Bioact Mater. 2024 Sep 10:42:433-448. doi: 10.1016/j.bioactmat.2024.08.044.

微生物疗法

2024-10-28

·蒲公英Ouryao

药典委：85个辅料标准研究征集样品

来源：国家药典委编辑：wangxinglai2004 2024年10月28日，国家药典委发布了《关于征集药用辅料标准研究用样品的通知（2024年第三批）》，共涉及85种辅料，要求辅料生产企业和使用单位配合提供符合要求的样品及有关资料，并于11月25日前邮寄或直接送至指定地址。 01 涉及品种: 苯甲酸、聚醋酸乙烯酯聚维酮共聚物（混合物）、聚乳酸、聚维酮K30 、聚乙烯醇、十七烷-9-基-8-（（2-羟乙基）（6-氧代-6-（（十一烷氧基）己基）氨基）辛酸酯）、盐酸半胱氨酸、棕榈酸十六酯、乙二胺、乙基纤维素、正丁醇、可压性蔗糖、丙交酯乙交酯共聚物(5050)(供注射用)）、丙交酯乙交酯共聚物(7525)(供注射用)、丙交酯乙交酯共聚物(8515)(供注射用) 、白凡士林、共聚维酮、交联聚维酮、异丙醇、纤维醋法酯、壳聚糖、环拉酸钠、油酰聚氧乙烯甘油酯、DL-酒石酸、L(+)-酒石酸、黄凡士林、脱氢醋酸、脱氧胆酸钠、羟丙甲纤维素邻苯二甲酸酯、羟丙基倍他环糊精、琥珀酸、葡萄糖二酸钙、硬脂酸聚烃氧(40)酯、硫酸羟喹啉、聚丙烯酸树脂Ⅱ、聚丙烯酸树脂Ⅲ、聚丙烯酸树脂Ⅳ、聚甲丙烯酸铵酯Ⅰ、聚甲丙烯酸铵酯Ⅱ、聚氧乙烯、聚氧乙烯油酸酯、聚氧乙烯(50)硬脂酸酯、聚氧乙烯(35)蓖麻油、聚维酮K30、蔗糖、碳酸丙烯酯、醋酸纤维素、醋酸钠、麝香草酚、果糖、月桂酰聚氧乙烯(6)甘油酯、月桂酰聚氧乙烯(8)甘油酯、月桂酰聚氧乙烯(12)甘油酯、月桂酰聚氧乙烯(32)甘油酯、乙酸乙酯、二丁基羟基甲苯、二甲基亚砜、三氯叔丁醇、三氯蔗糖、己二酸、马来酸、无水乳糖、D-木糖、肉豆蔻酸、麦芽酚、麦芽糖醇、伽马环糊精、间甲酚、没食子酸、阿尔法环糊精、环甲基硅酮、苯氧乙醇、DL-苹果酸、L-苹果酸、枸橼酸三乙酯、枸橼酸三正丁酯、香草醛、胆固醇、倍他环糊精、海藻糖、羟苯苄酯、硬脂富马酸钠、富马酸、腺嘌呤、蔗糖八醋酸酯； 02 通知原文各相关单位： 2024年我委将继续组织开展《中国药典》药用辅料标准研究。为增强药用辅料标准研究用样品的代表性，确保药用辅料标准的科学、合理和适用，充分发挥企业在标准制定中的积极作用，根据《药品标准管理办法》，现协助相关单位公开征集药用辅料标准研究用样品，具体如下：请各相关药用辅料生产企业和使用单位配合提供符合要求的样品及有关资料，于2024年11月25日前邮寄或直接送至“样品寄送地址”（详见附件），并与样品收集单位建立联系，以便在标准制修订过程中加强技术沟通和交流，配合进行数据验证等。前期提供过该项目所需样品的可不重复提供。请各有关协会在会员单位中广泛宣传，鼓励企业积极参与。我委将在网站公布提供样品及资料的企业和协会名单。联系电话：010-67079566

核酸药物

2023-07-13

·BioSpace

IQ-AI Announces Orphan Drug Designation for GaM in Pediatric GBM

MILWAUKEE, WI / ACCESSWIRE / July 13, 2023 / Imaging Biometrics, LLC (IB), a wholly-owned subsidiary of IQ-AI Ltd (LSE:IQAI)(OTCQB:IQAIF), today announced the U.S. Food and Drug Administration (US FDA) has granted Orphan Drug Designation (ODD) for gallium maltolate (GaM) for the treatment of pediatric glioblastoma multiforme (GBM). In February, IB was granted Orphan Drug Designation for adult GBM. The US FDA has since confirmed that the designation granted in February applies to both adult and pediatric GBM patients. GBM is the most common and aggressive primary brain tumor in adults and children. There are currently no effective treatments for pediatric glioblastoma. Oral GaM recently demonstrated significant survival benefit in a pre-clinical study for pediatric GBM. The results of the study, performed in the lab of Dr. Kathleen Schmainda, PhD and led by Dr. Mona Al-Gizawiy, PhD from the Medical College of Wisconsin (MCW), were presented at the 2023 Society of Neuro Oncology (SNO) Pediatric Conference in Washington, DC last month. Median overall survival was more than 2x longer in the group treated with GaM compared to the untreated controls. These promising results, coupled with the easy administration by capsule, make this a very attractive potential treatment option for both pediatric and adult patients. "We are very pleased that the FDA has now confirmed that the orphan drug designation for GaM applies to all GBM populations including pediatric patients," said Trevor Brown, CEO of IQ-AI. About Imaging Biometrics® LLC: IB is a wholly-owned subsidiary of IQ-AI Limited, (LON:IQAI)(OTCQB:IQAIF), and focuses on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company's website at . Follow IB on Twitter, @IQAI_IB. Contact Information: Michael Schmainda Tel: 262-439-8252 SOURCE: IQ AI Ltd. View source version on accesswire.com:

孤儿药临床结果

100 项与麦芽酚镓相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	麦芽酚镓	-	DB05420

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
细菌感染	临床3期	美国	Titan Pharmaceuticals, Inc.	-
非典型畸胎瘤	临床前	美国	Imaging Biometrics LLC	2023-10-05
多形性胶质母细胞瘤	临床前	美国	Imaging Biometrics LLC	2023-07-13
膀胱癌	临床前	美国	Titan Pharmaceuticals, Inc.	2001-06-01
去势抵抗性前列腺癌	临床前	美国	Titan Pharmaceuticals, Inc.	2001-06-01
多发性骨髓瘤	临床前	美国	Titan Pharmaceuticals, Inc.	2001-06-01
前列腺癌	临床前	美国	Titan Pharmaceuticals, Inc.	2001-06-01
恶性肿瘤体液性高钙血症	临床前	美国	Titan Pharmaceuticals, Inc.	-
畸形性骨炎	临床前	美国	Titan Pharmaceuticals, Inc.	-
类风湿关节炎	临床前	美国	Titan Pharmaceuticals, Inc.	-