On July 1, 2020 MetVital, Inc., a privately held biopharmaceutical company developing small molecule modulators of altered glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, reported that the U.S. Food and Drug Administration (FDA) has notified MetVital that its lead drug candidate, "Anhydrous Enol-Oxaloacetate" (AEO) received Fast Track Designation for the treatment of patients with newly diagnosed glioblastoma multiforme (GBM) (Press release, MetVital, JUL 1, 2020, View Source [SID1234561630]).
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AEO, a patented molecule, is MetVital’s lead clinical development candidate for treatment of glioblastoma multiforme, a malicious type of brain cancer.
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions which fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.
"FDA’s Fast Track Designation for our lead drug candidate is another important milestone for MetVital, as it can potentially speed the development of this drug for glioblastoma patients," said Alan Cash, president and chief executive officer of MetVital, Inc. AEO is also being tested in Investigator-initiated clinical trials for the treatment of Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease and in breast cancer survivors with cognitive complaints.
Anhydrous Enol-Oxaloacetate is a molecule that has demonstrated safety and efficacy in animal models with human glioblastoma tissue implants, in animal models of ALS, and in animal models of Alzheimer’s disease. US FDA Orphan Drug Designations for oxaloacetate have been received for gliomas, ALS, and hepatocellular carcinoma.
Glioblastoma multiforme is 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.