Fast Track Designation Granted for Tovaxin for Secondary Progressive Multiple Sclerosis

Opexa Therapeutics announced that the FDA has granted Tovaxin fast track designation for the treatment of patients with secondary progressive multiple sclerosis (SPMS). Opexa plans to initiate a Phase 2b clinical trial with Tovaxin in SPMS patients in lieu of the fast track designation.

Tovaxin is a personalized cellular immunotherapy treatment, derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time. 

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