Tovaxin™

Parent company: Opexa Therapeutics

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

A Phase II dose-escalation study (DES) compared three dose levels for safety and tolerability, changes in EDSS scores, and the frequency of MS relapses. Participants had RRMS (56 percent) or SPMS (44 percent) and were not responsive to approved immunomodulatory therapies. Significant improvements in the annualized relapse rate were seen, and there was a decrease in myelin-reactive T cells in the blood. The middle level dose was selected for future studies.

TERMS is an ongoing placebo-controlled one-year study in patients with CIS and RRMS to evaluate Tovaxin's efficacy, safety, and tolerability. ÊPatients completing the trial may participate in an open-label, one-year OLERMS extension study. Outcome measures will include changes in the number of gadolinium-enhancing lesions on brain MRI, the rate and severity of MS progression, and relapse rate.