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.
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