Still early days on this one, but the more the merrier...
PharmaFrontiers...Key Clinical Milestones in Multiple Sclerosis
THE WOODLANDS, Texas, Feb. 14, 2005 (PRIMEZONE) -- Cell therapy developer PharmaFrontiers Corp. (OTCBB:PFTR) has...reached critical milestones in two Phase I/II clinical trials to evaluate the application of its T Cell therapy in multiple sclerosis.
Two clinical studies of its Tovaxin autologous T Cell therapy for treatment of multiple sclerosis have reached critical milestones. In one study, a first group of 10 patients has been enrolled and received two doses of Tovaxin in a repeat treatment Phase I/II protocol designed to determine whether patients who received clinical benefit from T Cell therapy in a previous study conducted at the Baylor College of Medicine can be safely and effectively retreated with a second-generation T Cell therapy. Six-month clinical results evaluating safety, tolerability, dosage timing and efficacy are expected to be available by early Q305.
Additionally, in a Phase I/II dose-escalating study designed to evaluate safety, tolerability and efficacy in 9 to 15 patients, 6 patients have completed the initial four dose injection series for two dosage levels and the 28-week portion of the study. One-year clinical results evaluating safety, tolerability, dosage timing and efficacy are expected to be available by early Q305.
The company intends to submit data from these two clinical studies to the FDA for approval to commence a pivotal Phase IIb study in Q405.