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.”
The article, “ A randomized clinical trial of autologous T-cell therapy in multiple sclerosis: subset analysis and implications for trials design,” was published electronically ahead of print in OnlineFirst at http://msj.sagepub.com/content/early/2011/11/07/1352458511428462.full.pdf+html, and will be available through Open Access in a future edition of Multiple Sclerosis Journal.About Opexa Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as MS. The Company’s leading therapy, Tovaxin ®, is a personalized cellular immunotherapy treatment that is in late stage clinical development for MS. Tovaxin is derived from T-cells isolated from peripheral blood, expanded ex vivo, and reintroduced into the patients via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin and, thereby, reduces the risk of relapse over time. For more information visit the Opexa Therapeutics website at www.opexatherapeutics.com. Cautionary Statement Relating to Forward-Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “expects,” “believes,” “anticipates,” “estimates,” “may,” “could,” “intends,” “exploring,” “evaluating” and similar expressions are intended to identify forward-looking statements. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding the development of the Company’s product candidate, Tovaxin, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our capital position, the ability of the Company to enter into and benefit from a partnering arrangement for the Company's product candidate, Tovaxin, on reasonably satisfactory terms (if at all), our dependence (if partnered) on the resources and abilities of any partner for the further development of Tovaxin, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of developing a marketable product, our ability to raise additional capital to continue our treatment development programs and to undertake and complete any further clinical studies for Tovaxin, the success of our clinical trials, the efficacy of Tovaxin for any particular indication, such as for relapsing remitting MS or secondary progressive MS, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights (including for Tovaxin), the risk of litigation regarding our intellectual property rights, our limited manufacturing capabilities, our dependence on third-party manufacturers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date made. We assume no obligation or undertaking to update any forward-looking statements to reflect any changes in expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. You should, however, review additional disclosures we make in our reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2010.