MetVital issued the following announcement on June 11.
MetVital, Inc., a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential, announces that the U.S. Food and Drug Administration (FDA) has notified MetVital that it may proceed with its clinical investigation of "Anhydrous Enol-Oxaloacetate" (AEO) as a potential treatment for patients with Glioblastoma Multiforme. The notice to proceed was received following MetVital's submission of an investigational new drug (IND) application for this program. FDA has approved a Phase 2A "Proof of Concept" trial to advance.
AEO, a patented metabolite, is MetVital's lead clinical development candidate for Glioblastoma Multiforme, a malicious type of brain cancer. Measured endpoints in the trial include Overall Survival (OS), Progression Free Survival at 6 months (PFS-6) and Seizure amelioration.
"The FDA's acceptance of this commercial IND application is an important milestone for MetVital, as it allows us to immediately go into Phase 2A testing," said Alan Cash, president and chief executive officer of MetVital, Inc. "We are excited about the potential of modulating the excess glutamate levels in the central nervous system for patients with brain cancer, and the potential of the drug for a wide variety of other diseases." AEO is also being examined in Investigator lead clinical trials for the treatment of Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's disease.
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. 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.
About MetVital, Inc.
MetVital, Inc. is a biopharmaceutical company developing small molecule modulators of glutamate metabolism for the treatment of diseases with significant unmet medical need and commercial potential. MetVital's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding MetVital, please visit MetVital's website at www.MetVital.com.
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