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

Start Date-

Sponsor / Collaborator

Imaging Biometrics LLC

[+1]

NCT04319276 / RecruitingPhase 1IIT

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).

Start Date11 Nov 2022

Sponsor / Collaborator

Medical College of Wisconsin

NCT00050687 / TerminatedPhase 1/2

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.

Start Date01 Jun 2001

Sponsor / Collaborator

Titan Pharmaceuticals, Inc.

100 Clinical Results associated with Gallium Maltolate

100 Translational Medicine associated with Gallium Maltolate

100 Patents (Medical) associated with Gallium Maltolate

Literatures (Medical) associated with Gallium Maltolate

01 Dec 2024·Bioactive Materials

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

Article

Author: 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.

01 Apr 2024·Acta Tropica

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

Article

Author: 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.

01 Aug 2023·Cellular Oncology

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

Article

Author: 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.

News (Medical) associated with Gallium Maltolate

13 Jul 2023

·www.biospace.com

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:

Orphan DrugClinical Result

100 Deals associated with Gallium Maltolate

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KEGG	Wiki	ATC	Drug Bank
-	Gallium Maltolate	-	DB05420

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Infections	Phase 3	US	Titan Pharmaceuticals, Inc.	-
Teratoid Tumor, Atypical	Preclinical	US	Imaging Biometrics LLC	05 Oct 2023
Glioblastoma Multiforme	Preclinical	US	Imaging Biometrics LLC	13 Jul 2023
Bladder Cancer	Preclinical	US	Titan Pharmaceuticals, Inc.	01 Jun 2001
Castration-Resistant Prostatic Cancer	Preclinical	US	Titan Pharmaceuticals, Inc.	01 Jun 2001
Multiple Myeloma	Preclinical	US	Titan Pharmaceuticals, Inc.	01 Jun 2001
Prostatic Cancer	Preclinical	US	Titan Pharmaceuticals, Inc.	01 Jun 2001
Humoral Hypercalcemia of Malignancy	Preclinical	US	Titan Pharmaceuticals, Inc.	-
Osteitis Deformans	Preclinical	US	Titan Pharmaceuticals, Inc.	-
Rheumatoid Arthritis	Preclinical	US	Titan Pharmaceuticals, Inc.	-

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