Opexa to Present Tovaxin® Data at the American Academy of Neurology 2009 Annual Meeting
Key data from TERMS Phase IIb clinical study in multiple sclerosis highlighted in poster presentation
THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS) and a stem cell therapy for diabetes, announced today that Edward Fox, MD, PhD, director of the Multiple Sclerosis Clinic of Central Texas and the principal investigator and co-author of the TERMS (Tovaxin® for Early Relapsing Multiple Sclerosis) clinical study will present data from the Phase IIb TERMS clinical trial at the upcoming American Academy of Neurology (AAN) 61st Annual Meeting to be held in Seattle, WA.
Dr. Fox will present the data during a poster session on Wednesday, April 29, 2009 from 4-7:00 p.m. at Poster Session VI, located at P06.132 in the poster hall under the following title: TERMS Trial T-Cell Vaccination Secondary Analysis of Clinical and Immunologic Outcomes in Relapsing Remitting Multiple Sclerosis Patients.
About Tovaxin
Tovaxin is an individualized cellular immunotherapy treatment in Phase IIb 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.
Opexa completed its 150 patient landmark TERMS Phase IIb clinical study in late 2008 which was one of the first clinical studies investigating an autologous T-cell therapy in MS patients. Data from this clinical study show compelling evidence that Relapsing Remitting MS (RRMS) patients treated with Tovaxin saw overall clinical, MRI, and immunological benefits over the placebo group, including statistical significance for decrease in the Annualized Relapse Rate (ARR), improvement in disability score (EDSS), and improvement in quality of life measures (MSQLI), as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.
About Opexa
Opexa Therapeutics, Inc. is dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases. The Company’s leading therapies currently in development have the potential to address significant unmet medical needs in several large patient populations including multiple sclerosis and diabetes. The Company’s therapies are based on proprietary, autologous T-cell and stem cell technologies.
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 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 current or future financial performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance, 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: the success of collaborative relationships, 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, the success of our clinical trials, 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 for our products, the risk of litigation regarding our intellectual property rights, our limited manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, 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. We assume no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.

