Biopharmaceutical company MetVital Inc said on Tuesday that it will proceed with its clinical investigation of 'Anhydrous Enol-Oxaloacetate' (AEO) as a potential treatment for patients with Glioblastoma Multiforme following the US Food and Drug Administration (FDA) approval.
Glioblastoma Multiforme is reportedly the most aggressive of the gliomas. It is often referred to as a grade IV astrocytoma and is the most common type of brain cancer.
The US FDA notice follows the submission of the company's investigational new drug (IND) application for the Phase 2A 'Proof of Concept' trial.
AEO is a patented metabolite and is the company's lead clinical development candidate for Glioblastoma Multiforme. The measured endpoints in the trial include Overall Survival (OS), Progression Free Survival at six months (PFS-6) as well as Seizure amelioration.
According to the company, the Anhydrous Enol-Oxaloacetate is a metabolite that has demonstrated efficacy in animal models with human Glioblastoma Multiforme tissue implants, in animal models of ALS, and in animal models of Alzheimer's disease. The US FDA Orphan Drug Designations for oxaloacetate have been received for Gliomas, ALS and Hepatocellular Carcinoma.
NeuroSense Therapeutics completes safety evaluation of PrimeC in Alzheimer's Phase 2 study
BrioHealth Solutions enrols 100th participant in BrioVAD System trial
Faron launches BLAZE trial with Institute of Cancer Research to address immunotherapy resistance
AstraZeneca secures US Breakthrough status for Enhertu in early breast cancer
Ipsen licenses Simcere Zaiming antibody-drug conjugate for global development
Shield Therapeutics wins FDA approval to expand ACCRUFeR use to adolescents
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Ipsen closes Phase II FALKON trial after missing primary endpoint in FOP
Curasight reports first patient dosed in Phase 1 uTREAT trial in brain cancer
Clywedog Therapeutics activates all clinical centres and patient dosing in balomenib Phase 1b study
PRISM BioLab partners with Talus Bioscience to address TF and PPI targets
Thryv Therapeutics reports positive Phase 1 results for THRV-1268