"Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company leading in the development of cell therapies for multiple sclerosis announced today that the Data Safety Monitoring Board (DSMB) 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 DSMB in June 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 (Tovaxin for Early Relapsing Multiple Sclerosis) is nearing completion and the DSMB has two additional scheduled meetings in July and August of this year. 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 (CIS).
The trial was initiated in the third quarter of 2006 and enrollment was completed in the second quarter of 2007. Dosing was completed in the first quarter of 2008 and currently patients are completing their final weeks 44 and 52 follow-up visits. 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 (ARR) and additional MRI measurements.