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.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA