Positive results for Opexa in ongoing MS study

Phase I/II trials indicated that after 12 months, patients exhibited a relapse rate reduction of more than 90%.

The company has initiated its phase IIb study with Tovaxin and expects enrollment of patients to commence sometime next year. Opexa said that 35 clinical sites have begun screening patients for the 150-patient trial. The phase IIb clinical study will be designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T Cell vaccination with clinically isolated syndrome (CIS) 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 open-label. The open-label study is being planned under a different protocol that will be submitted to the FDA.

“We are pleased to begin this trial and based on recent data from our phase I/II studies, we believe that those early results support the rationale for moving forward. We now have 12-month data from our two earlier studies, which indicate that the patients treated had a greater than 90% annualized relapse rate reduction, as compared with their prior history,” said David McWilliams, president and CEO of Opexa.

Opexa also announced that it has advanced its preclinical program in diabetes with the initiation of animal studies at the University of Texas Medical Branch at Galveston. Data from the animal studies are expected in the first quarter of 2007