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2 FDA Meetings re P3 Tovaxin® Clinical Multiple Sclerosis Study, Opexa (OPXA)

OPXA’s Tovaxin® for multiple sclerosis (NYSE:MS) completed 2 separate and successfull meetings with the FDA regarding the development program for Tovaxin.
  • Tovaxin is the 1st personalized T-cell therapy for MS patients advancing to Phase 3 clinical studies.

OPXA’s recent discussions with the FDA consisted of 2 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 1st face-to-face meeting focused on the improvements and modifications incorporated into Tovaxin’s manufacturing and CMC  processes in an effort to improve efficiency, reduce overall costs and implement commercial stage requirements.

  • Data was presented with 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 2nd meeting was a face-to-face presented rationale and trial design for a Phase 3 pivotal study with Tovaxin in Relapsing Remitting-MS (RR-MS) patients.

  • The FDA concurred 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;
  • This statistically significant efficacy result, coupled with the safety profile of Tovaxin, was highlighted during the FDA meeting to emphasize a promising benefit-to-risk profile for Tovaxin.

Based on positive feedback from the FDA, OPXA believes it is now positioned from a regulatory perspective to advance a pivotal Phase 3 clinical study of Tovaxin in MS and possibly a partner.

  • OPXA closed up $0.84 at $2.40 or 53.85% on 1/5/11.