Opexa (OPXA) initiates discussions with Health Canada in Pre-CTA Meeting
OPXA 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.). OPXA presented data related to the safety and efficacy of Tovaxin and reviewed the manufacturing process and clinical trial protocol for the planned P3 program.
The Bottom Line: Health Canada acknowledged the novel approach of 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 OPXA held with the FDA several months ago, paves the way to potentially use Canadian sites in any future trial with Tovaxin. OPXA envisions using both US and Canadian trial sites in the planned P3 program. Canada has some of the most respected MS opinion leaders in the world, a couple of which are on OPXA’s Advisory Board and several of the leading treatment centers for MS. The 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. OPXA 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 valuable guidance from the Agency in fine-tuning its development plan.
- OPXA is up $0.01 (0.89%) to $1.67 in early trading