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MetVital, Inc. Announces FDA Clearance of Investigational New Drug (IND) Application for AEO for Phase 2 testing for Glioblastoma Multiforme
SAN DIEGO, June 11, 2019 /PRNewswire/ -- 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, today 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.
Statements in this press release that are not historical facts, including statements about future expectations of MetVital, Inc., such as statements about potential clinical indications for AEO, clinical trial results with AEO, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates and market potential for product candidates, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. MetVital intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause MetVital's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. MetVital's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, MetVital's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of MetVital's products, and other factors discussed in MetVital's periodic filings with regulating authorities. MetVital is not responsible for updating for events that occur after the date of this press release.
Contact: Devon Lantry, 858-947-5722
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SOURCE MetVital, Inc.