The company believes that completion of this trial will allow the launch of a pivotal phase III trial for the drug.
This phase IIb clinical study is designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell therapy with clinically isolated syndrome (CIS) and early relapsing-remitting MS patients.
Additionally, the study of these patients will evaluate biomarkers of Tovaxin’s efficacy and to evaluate the effect of Tovaxin on immune deviation and epitope spreading.
“PharmaFrontiers is very excited to receive a ‘green light’ from the FDA for our phase IIb clinical trial. Our earlier open-label phase I/II clinical trials not only gave us the safety and tolerability data we sought, but we also observed a trend towards a reduction in annualized relapse rate in excess of 90%,” said David McWilliams, CEO of PharmaFrontiers.