PharmaFrontiers trial design for Tovaxin against multiple sclerosis accepted by FDA

New York, Oct. 31 - PharmaFrontiers Corp. said the Food and Drug Administration has accepted the design of its proposed phase IIb clinical trial of Tovaxin, a novel T cell therapeutic vaccine for multiple sclerosis.

"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%, the lowering of the myelin-peptide reactive T cells in patients blood and the improvement in patients' clinical measures," said David B. McWilliams, chief executive officer of PharmaFrontiers, in a news release.

"The Tovaxin clinical program continues to show promising results and we believe that the completion of this Phase IIb clinical trial will allow us to launch a Phase III pivotal trial."

The multicenter, randomized, double blind, placebo-controlled phase IIb clinical study is designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T cell therapy with clinically isolated syndrome 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.

Patients who complete the study will be eligible to participate in an optional one-year extension study, in which they will receive Tovaxin open-label. That study is being planned under a different protocol that will be submitted to the FDA.

"A patient-specific therapeutic vaccination strategy, Tovaxin T cell vaccine is formulated using the MS patient's own myelin peptide-specific activated T cell lines, which are harvested and attenuated on the day of vaccine administration," added Jim C. Williams, PharmaFrontiers chief operating officer.

PharmaFrontiers is a The Woodlands, Tex.-based developer of cell therapies.

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