FDA Grants Fast Track Designation to Novel Molecule to Treat Glioblastoma

The FDA granted Fast Track designation to the glutamate-binding molecule, anhydrous enol-oxaloacetate (AEO), for the treatment of patients with newly diagnosed glioblastoma multiforme.

"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 CEO of MetVital, Inc, in a statement. AEO is also being tested in Investigator-initiated clinical trials for the treatment of amyotrophic lateral sclerosis, Alzheimer's disease, and in breast cancer survivors with cognitive complaints.

In glioblastoma, a multicenter, open-label, phase 2, proof-of-concept clinical trial has been opened to evaluate adjuvant AEO in combination with the standard of care (SoC), which is surgery, radiation, and chemotherapy with temozolomide (Temodar) against SoC alone (NCT04450160). The coprimary end points of the study will be overall survival and progression-free survival. The study will also explore seizures, Chalfont-National Hospital Seizure Severity, and PROMIS-Cancer fatigue as secondary end points.

The study has not yet begun recruiting, but aims to enroll 80 patients for whom the key eligibility criteria include histopathologic diagnosis of glioblastoma, good hemoglobin (>9 g/dL) and platelet (>100,000/microliter) levels, and a Karnofsky performance status >70. Patients will be excluded from the study if they have a significant concurrent illness or disease, are receiving concomitant treatment with tumor-treating electric fields or carmustine wafers, have an estimated life expectancy less than 6 months at the time of randomization, or if they are pregnant. Patients receiving concomitant anti-epileptic drugs are eligible though.

AEO turns into oxaloacetate in the body, which has been found to alter cancer metabolism in glioblastoma cells, reducing glycolysis and lactate production.

Prior to the launch of the phase 2 trial, the safety and efficacy associated with AEO was shown in animal models with human glioblastoma tissue implants. Preclinically, the drug slowed down the rate of tumor growth and led to increased survival. The agent has also shown promise in hepatocellular carcinoma and gliomas, which have led to Orphan Drug designations from the FDA.

The Fast Track designation will facilitate the development of AEO in the glioblastomalandscape and also accelerate the FDA review of clinical research around the drug.

_Reference:

_{MetVital, Inc. announces FDA Fast Track designation of anhydrous enol-oxaloacetate (AEO) for the treatment of patients with newly diagnosed glioblastoma multiforme. News release. MetVital, Inc. June 1, 2020. Accessed June 2, 2020. https://prn.to/31ya1vQ}