Opexa Therapeutics, Inc. (NASDAQ:OPXA), a leading cell therapy company developing Tovaxin® for multiple sclerosis(MS), announced the successful completion of two separate meetings with the U.S. Food and Drug Administration (FDA) regarding the Company’s planned development program for Tovaxin. Based on positive feedback from the FDA, Opexa believes it is now positioned from a regulatory perspective to advance with a pivotal Phase 3 clinical study of Tovaxin in MS. The Company is in the process of completing necessary preparations to be able to initiate such a study.
“We are very pleased with the outcome of our two recent FDA meetings regarding Tovaxin, the first ever personalized T-cell therapy for MS patients, as we believe we now have a well defined path forward for Phase 3 clinical studies,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. “Importantly, we believe the outcome of these meetings will contribute positively to our ongoing discussions with potential development partners due to the importance of the FDA’s feedback, as well as our ability to secure the necessary resources for the continued development of Tovaxin. We remain motivated to again treat patients in a clinical setting as we continue to believe Tovaxin is the most promising therapy in development for MS.”
“Tovaxin has shown promise throughout its clinical development and I am pleased that Opexa is prepared from a regulatory perspective to move forward with pivotal trials,” commented Clyde Markowitz, M.D., director of the Multiple Sclerosis Center at the University of Pennsylvania, professor of neurology at the University of Pennsylvania School of Medicine in Philadelphia and member of Opexa’s scientific advisory board. “As a clinical investigator in Opexa’s last clinical trial with Tovaxin and having treated several of my patients in this clinical setting, I am particularly impressed with its excellent safety profile. Based on my clinical experience, I am excited that Opexa is preparing to conduct Phase 3 trials with Tovaxin to advance the therapy closer to the market and those MS patients in need of improved therapies.”
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