In this clinical trial, Tovaxin therapy was shown to be safe and effective. The analysis showed that Tovaxin therapy achieved a 90% reduction in annualized relapse rate in subjects who received one of the three doses.
The safety profile for all dosage levels revealed no severe adverse reactions related to T-cell vaccination. With increasing dosage, an increase in mild injection site reactions was observed and these resolved within 48 hours.
The Tovaxin phase IIb clinical study will include 150 patients in a trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T-cell vaccination with clinically isolated syndrome and relapsing-remitting MS patients.
All patients who complete the trial will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin under an open-label protocol. The open-label study is being planned under a different protocol that will be submitted to the FDA.