gallium maltolate / Medical College of Wisconsin, Imaging Biometrics - LARVOL DELTA

A phase 1 trial of iron metabolism-targeting oral gallium maltolate in recurrent and refractory glioblastoma. (PubMed, Neurooncol Adv) - "Oral gallium maltolate is safe and well-tolerated with an RP2D of 2,000 mg/day. Further investigation to assess the clinical efficacy of gallium maltolate in GBM is warranted."

Journal • P1 data • Anorexia • Brain Cancer • Fatigue • Glioblastoma • Oncology • Solid Tumor

Reharnessing the therapeutic potential of gallium-based compounds in oncology: From the laboratory to the clinic. (PubMed, Pharmacol Rev) - "Recent insights into gallium's molecular targets have advanced the translation of gallium from the laboratory to a clinical trial of oral gallium maltolate in glioblastoma. Newer gallium compounds are being developed; their advancement is eagerly anticipated."

Journal • Review • Brain Cancer • Glioblastoma • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • Urothelial Cancer

Oral Gallium Maltolate for Recurrent Glioblastoma (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Medical College of Wisconsin

New P1 trial • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

The oral iron mimetic gallium maltolate is neurologically safe in a rat xenograft model of glioblastoma: multimodal assessment (SNO 2025) - "GaM therapy does not cause overt neurotoxicity and is associated with excellent quality of life."

Preclinical • Brain Cancer • Glioblastoma • Solid Tumor

RNA-sequencing to investigate antineoplastic mechanisms of gallium maltolate in glioblastoma (SNO 2025) - P1 | "This data underscores that several previously studied mechanisms of Ga in cancer are also active with GaM in glioblastoma. The many genes and pathways not previously known to be influenced by GaM will provide foundation for future mechanistic studies."

Brain Cancer • Glioblastoma • Solid Tumor • HMOX1

Ferroportin-dependent iron efflux as a novel mechanism of gallium maltolate in glioblastoma (SNO 2025) - "Our results indicate GaM contributes to intracellular iron depletion by increasing ferroportin-mediated iron efflux. Changes in ferroportin appear to modulate cell sensitivity to GaM, suggesting that ferroportin plays a functional role in GaM's antiproliferative mechanism of action. Ongoing studies of GaM sensitivity and Ga export in ferroportin-inducible GBM cells will also be presented."

Brain Cancer • Glioblastoma • Solid Tumor

The oral iron mimetic gallium maltolate is neurologically safe in a rat xenograft model of glioblastoma: multimodal assessment (WFNOS 2025) - P1/2 | "GaM therapy does not cause overt neurotoxicity and is associated with excellent quality of life."

Preclinical • Brain Cancer • Glioblastoma • Glioma • Solid Tumor

RNA-sequencing to investigate antineoplastic mechanisms of gallium maltolate in glioblastoma (WFNOS 2025) - P1 | "This data underscores that several previously studied mechanisms of Ga in cancer are also active with GaM in glioblastoma. The many genes and pathways not previously known to be influenced by GaM will provide foundation for future mechanistic studies."

Brain Cancer • Glioblastoma • Solid Tumor • HMOX1

Ferroportin-dependent iron efflux as a novel mechanism of gallium maltolate in glioblastoma (WFNOS 2025) - "Our results indicate GaM contributes to intracellular iron depletion by increasing ferroportin-mediated iron efflux. Changes in ferroportin appear to modulate cell sensitivity to GaM, suggesting that ferroportin plays a functional role in GaM’s antiproliferative mechanism of action. Ongoing studies of GaM sensitivity and Ga export in ferroportin-inducible GBM cells will also be presented."

Brain Cancer • Glioblastoma • Solid Tumor

Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Medical College of Wisconsin | Trial completion date: Oct 2025 ➔ Mar 2027

Trial completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: Medical College of Wisconsin | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Imaging Biometrics to revise FDA application for brain cancer drug after positive feedback (Proactiveinvestors) - "Imaging Biometrics Ltd...said it will revise its application for Breakthrough Therapy Designation in the US, following discussions with the Food and Drug Administration. The company is developing oral gallium maltolate, a treatment aimed at aggressive brain tumours that have not responded to standard therapies. It had submitted the drug for consideration under the FDA's Breakthrough Therapy programme, which is designed to fast-track promising new treatments. US regulators have now advised the company to resubmit the application with a more mature data package. Imaging Biometrics said the FDA responded positively to initial results and encouraged a revised submission once further analysis is complete. The company said it is now working to incorporate new biomarker and imaging data to strengthen the case for the drug."

Breakthrough therapy • Glioblastoma

Imaging Biometrics seeks FDA breakthrough status for cancer therapy (Investing.com) - "Imaging Biometrics, LLC...has submitted an application for Breakthrough Therapy Designation to the U.S. Food and Drug Administration (FDA) for its oral gallium maltolate (GaM) treatment for glioblastoma. The Phase 1 trial results indicate a potential to extend overall survival in patients with this aggressive brain cancer."

Breakthrough therapy • Glioblastoma

Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Medical College of Wisconsin; Trial completion date: Jul 2024 ➔ Jul 2025; Initiation date: Jul 2020 ➔ Jul 2021

Trial completion date • Trial initiation date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

[VIRTUAL] Involvement of the lysosome in the cytotoxicity of Gallium Maltolate in human pediatric brain tumor cell lines (AACR-II 2020) - "Our results identify GaM as a novel compound with significant activity against a panel of cell lines representative of pediatric brain tumors. Most of the cell lines used in our study were derived from tumors taken from heavily pre-treated patients and were resistant to conventional chemotherapeutic drugs. Their sensitivity of GaM suggests that GaM does not share cross-resistance with other antineoplastic drugs."

Brain Cancer • Glioblastoma • Oncology • Rhabdoid Tumor • Sarcoma

Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Medical College of Wisconsin

Clinical • New P1 trial