Tovaxin™

Parent company: Opexa Therapeutics

• This is a T-cell vaccine given via subcutaneous injection every four weeks. In this process, T cells are removed from a small amount of the patient's blood, inactivated, and then injected back into the patient. As a result, the immune system is stimulated to recognize and eliminate the inactivated cells as well as active cells.


• A Phase II study showed significant improvements in the annualized relapse rate of patients with RRMS or SPMS, and there was a decrease in myelin-reactive T cells in the blood.


• TERMS is an ongoing placebo-controlled one-year study in patients with CIS and RRMS to evaluate Tovaxin's efficacy, safety, and tolerability. Participants in the trial also participated in an open-label, one-year extension study. The treatment was found to be safe, but did not achieve statistical significance in the primary endpoint, which was the cumulative number of gadolinium-enhancing lesions. Additional analysis of immunologic and other effects are ongoing, and further clinical trials may be developed.