Opexa Therapeutics, Inc. (NASDAQ:OPXA), developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today announced that results of the Company’s prior Phase IIb clinical trial of Tovaxin have been published in a leading peer-reviewed publication, Multiple Sclerosis Journal.
The Phase IIb placebo-controlled study [Tovaxin for Early Relapsing Multiple Sclerosis (TERMS)] was conducted in 150 patients, evaluating safety and efficacy of Tovaxin in relapsing-remitting MS patients (RRMS) and those with clinically isolated syndrome. The TERMS study, first reported in 2008, showed that Tovaxin was well-tolerated, with no serious adverse events, and demonstrated encouraging clinical results in the reduction of the annualized relapse rate (ARR) and improvement in disease progression.
“The TERMS trial was a landmark study in that it was the first time that a personalized immunotherapy of this nature was used to treat MS patients,” commented Edward Fox, MD, PhD, director of the MS Clinical of Central Texas, and a principal investigator in the TERMS study. “The results were encouraging in that they supported the continued development of Tovaxin in both relapsing remitting and secondary progressive MS.”
“The data from the TERMS study were important for a number of reasons, including demonstrating a strong safety profile and supportive efficacy findings,” said Neil K. Warma, President and Chief Executive Officer of Opexa. “Furthermore, the sub-population analyses were critical to increasing our understanding of the mechanism of action of Tovaxin. The sub-population of patients with more active disease – those with a baseline ARR greater than 1 – demonstrated a benefit for Tovaxin in terms of annualized relapse rate and disability progression, with many of these patients showing an improvement in their disability. We believe that we can draw important parallels from this group to those patients we will be targeting for our secondary progressive MS (SPMS) clinical program. We are currently preparing for a Phase IIb clinical trial of Tovaxin in SPMS, once we secure the necessary funding, as we have just received Fast Track designation from the U.S. FDA for SPMS.”