Opexa completes meetings with FDA regarding planned development program for Tovaxin

Jan 6 2011

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a leading cell therapy company developing Tovaxin^® for multiple sclerosis (MS), today 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.

“The positive outcome of these meetings with the FDA and the fact that we were able to complete these meetings during 2010 is the result of hard work by a focused and talented Opexa team”

"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."

Opexa's recent discussions with the FDA consisted of two separate End of Phase 2 meetings to review both the complete Tovaxin manufacturing process, as well as the going-forward clinical trial plan for Tovaxin. The first face-to-face meeting focused on the improvements and modifications Opexa has incorporated into Tovaxin's manufacturing and CMC (Chemistry, Manufacturing and Control) process in an effort to improve efficiency, reduce overall costs and implement commercial stage requirements. As part of this meeting, Opexa presented data and details supporting an optimized manufacturing process, including a transition to fewer process steps, comparability plans and complete reagent profiles. The FDA agreed that the optimized Tovaxin manufacturing process would meet the requirements for a pivotal Phase 3 clinical trial. Additional supporting data is expected to be submitted to the FDA prior to initiating such a study.

The second meeting was a face-to-face End of Phase 2 clinical meeting in which Opexa presented its rationale and trial design for a Phase 3 pivotal study with Tovaxin in Relapsing Remitting-MS (RR-MS) patients. The FDA concurred with Opexa regarding its proposed clinical trial protocol including the patient population, end points, patient numbers and trial design. The FDA also offered several recommendations to further enhance a Phase 3 trial. The Phase 3 clinical trial protocol presented to the FDA was based, in part, on a recently conducted analysis of data from the previous Phase 2b TERMS trial in a sub-population of patients that were naïve to disease modifying agents (i.e., patients who had not previously used any drugs other than steroids to treat their disease). The analysis produced encouraging results which showed that these patients, when treated with Tovaxin, had a 64% reduction in annualized relapse rate versus placebo>

"The positive outcome of these meetings with the FDA and the fact that we were able to complete these meetings during 2010 is the result of hard work by a focused and talented Opexa team," said Mr. Warma. "In the months leading up to these meetings, we worked on significantly improving the efficiency of the process used to manufacture Tovaxin and have taken critical steps to move closer to a commercial ready process. Additionally, we analyzed the clinical data from all previous Tovaxin studies to determine what we believe is an optimal trial design to support our Phase 3 program and spent substantial time obtaining expert advice and guidance from our scientific advisory board. Moving forward we are focused on implementing the necessary steps to advance toward a Phase 3 clinical trial, continuing discussions with potential development partners for Tovaxin and attempting to secure appropriate financing. We remain committed to the further development of Tovaxin."

SOURCE Opexa Therapeutics, Inc.