Opexa Wins Positive Review for Phase IIb Multiple Sclerosis Study
Opexa Therapeutics has announced that the data safety monitoring board overseeing the on-going Phase IIb clinical study of Tovaxin has recommended that the trial continue unmodified.
This positive recommendation follows a regularly scheduled meeting of the data safety monitoring board (DSMB) in June 2008, and is based upon an evaluation of clinical, magnetic resonance imaging (MRI) and safety data that had been recorded for all patients to date.
The Terms trial is nearing completion and the DSMB has two additional scheduled meetings in July and August of 2008. Tovaxin is being evaluated in a multi-center, randomized, double blind, placebo controlled study in 150 patients suffering from relapse remitting multiple sclerosis (RRMS) or clinically isolated syndrome.
The primary endpoint being evaluated in this trial is the cumulative number of contrast (gadolinium) enhancing brain lesions (CEL) using MRI, an important and objective measure of MS disease activity. Secondary endpoints include annualized relapse rate and additional MRI measurements. Opexa expects to announce top line results in September 2008.