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Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company met this week with Health Canada’s Biologics and Genetics Therapies Directorate (BGTD), in a pre-Clinical Trial Application (pre-CTA) meeting. A complete CTA must be filed with and approved by BGTD prior to the initiation of a clinical trial in Canada.
The pre-CTA consultation meeting provided an opportunity for Opexa to review the status of the Tovaxin development with the Canadian Health Authority (the equivalent to the FDA in the U.S.). Opexa presented data related to the safety and efficacy of Tovaxin and reviewed the manufacturing process and clinical trial protocol for the planned Phase III program. Health Canada provided valuable guidance on the planned clinical trial further enhancing Opexa’s goal of a successful outcome.
“Canada has one of the highest prevalence of MS in the world and as such there has evolved a tremendous expertise in researching and managing the disease. We would welcome Opexa to conduct their pivotal studies in Canada, giving our patients an opportunity to experience a promising new and innovative therapy and allow our researchers to gain experience in this exciting area of treatment,” commented Mark S. Freedman, MSc MD FAAN FRCPC, Director of Multiple Sclerosis Research Unit, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario Canada.
Neil Warma, President and CEO of Opexa Therapeutics, commented, “Health Canada acknowledged the novel approach of our T-cell technology for the treatment of MS and commented on the encouraging safety and efficacy data collected to date. This discussion, similar to those we held with the U.S. FDA several months ago, paves the way for us to potentially use Canadian sites in any future trial with Tovaxin. We envision using both U.S. and Canadian trial sites in the planned Phase III program. Canada has some of the most respected MS opinion leaders in the world, a couple of which are on our Advisory Board, and several of the leading treatment centers for MS. Our next step will be to prepare and submit the full dossier on Tovaxin as part of the CTA, which we envision completing over the next few months. We will need a positive review and approval from Health Canada prior to initiating any clinical study, but this meeting was a key step in the process and allowed us to gain valuable guidance from the Agency in fine-tuning our development plan.”