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.

NCT06404034 / AvailableN/A

Expanded Access to Gallium Maltolate (GaM) for Adult Patients With Relapsed/Refractory Histologic or Molecular Glioblastoma

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

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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转化医学

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

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

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 (Dordrecht)

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

Article

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

PURPOSE:

Breast 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.

METHODS:

TNBC 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.

RESULTS:

GaM 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.

CONCLUSIONS:

These 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）

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

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适应症	最高研发状态	国家/地区	公司	日期
膀胱癌	临床2期	美国	Titan Pharmaceuticals, Inc.	2001-06-01
去势抵抗性前列腺癌	临床2期	美国	Titan Pharmaceuticals, Inc.	2001-06-01
多发性骨髓瘤	临床2期	美国	Titan Pharmaceuticals, Inc.	2001-06-01
前列腺癌	临床2期	美国	Titan Pharmaceuticals, Inc.	2001-06-01
恶性肿瘤体液性高钙血症	临床1期	美国	Titan Pharmaceuticals, Inc.	-
畸形性骨炎	临床1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
细菌感染	临床前	美国	Titan Pharmaceuticals, Inc.	-
类风湿关节炎	临床前	美国	Titan Pharmaceuticals, Inc.	-