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 Opexa Therapeutics, Inc.
August 05, 2010 08:30 AM Eastern Time 

Opexa Reconstitutes Scientific Advisory Board with Industry Leaders

New Board of Advisors to Support Further Clinical Development of Tovaxin®

THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), today announced it has reconstituted its Scientific Advisory Board with notable key opinion leaders in the MS field. Members of the Advisory Board include Dawn McGuire, M.D. (Chair); Doug Arnold, M.D.; Edward Fox, M.D., Ph.D; Hans-Peter Hartung, M.D.; Clyde Markowitz, M.D.; Paul O’Connor, M.D.; Chris H. Polman, M.D. and Arthur Vandenbark, Ph.D.

“We welcome these distinguished leaders to our team and greatly appreciate their interest and willingness to lend their considerable talents to our development efforts.”

“Opexa is developing Tovaxin, a novel immunotherapy for multiple sclerosis, and this board of advisors represents some of the best and most highly regarded neurologists and immunologists in the world. Each has developed substantial expertise relevant to the further development of Tovaxin including designing and participating in numerous MS clinical trials, understanding U.S. and EU regulatory requirements, new product development, and T-cell immunology and their guidance will be instrumental in our ongoing plans to advance Tovaxin,” said Neil K. Warma, President and Chief Executive Officer. “We welcome these distinguished leaders to our team and greatly appreciate their interest and willingness to lend their considerable talents to our development efforts.”

Hans-Peter Hartung, M.D. – Dr. Hartung holds the Chair of Neurology at Heinrich-Heine University, Düsseldorf and is chairman of the Department of Neurology. Professor Hartung is a member of a large number of international and nation societies, serving on executive boards (President ECTRIMS; European Neurological Society, International Society for Neuroimmunology, International Federation of Multiple Sclerosis Societies; World Health Organization Advisory Board on Multiple Sclerosis), as well as on the editorial board of a number of international journals. He has authored or co-authored more than 400 articles in peer reviewed journals, written more than 80 book chapters and edited 7 books on neurology, neuroimmunology, peripheral nerve disease and multiple sclerosis.

Chris H. Polman, M.D. – Dr. Polman is Professor of Neurology and Director of Multiple Sclerosis Centre at the Vrije Universiteit Medical Center in Amsterdam, The Netherlands. He has published over 250 papers on multiple sclerosis. He served as the lead investigator for the AFFIRM trial and is active on numerous medical associations including the American Academy of Neurology, the Multiple Sclerosis International Federation (MSIF), and is a member of The World Congress Scientific Program Committee. Dr. Polman is the Deputy Chairman of the MSIF and is considered one of Europe’s leading MS specialists.

Paul O’Connor, M.D. – Dr. O’Connor is a neurologist and MS Clinic Director at St. Michael’s Hospital, University of Toronto where he serves as Professor of Medicine – Neurology. He holds the appointment of National Scientific and Clinical Advisor for the Multiple Sclerosis Society of Canada. He is past president of the Canadian Network of MS Clinics. Dr. O’Connor is a leading clinical investigator and respected key opinion leader in the field of MS having written over 150 clinical and scientific articles. He is a world authority on the design and implementation of clinical trials in MS and has served as lead-investigator or on the steering committee of trials for several new agents including monoclonal antibodies, natalizumab and rituxumab, as well as fingolimond, taxol and various interferons.

Arthur Vandenbark, Ph.D – Dr. Vandenbark is a Senior Research Career Scientist and Co-Director of the Neuroimmunology Research Laboratory at the Portland Veterans Affairs Medical Center, Portland, Oregon. He is also Professor of Neurology and Molecular Microbiology and Immunology and Director of the Tykeson Multiple Sclerosis Research Laboratory at Oregon Health and Science University. Dr. Vandenbark’s research program has focused on developing novel therapeutic strategies directed at modulating myelin antigen specific T cells that are likely to be involved in the pathogenesis of multiple sclerosis. He has published more than 270 research papers and has been granted numerous patents and technology development awards.

Clyde Markowitz, M.D. – Dr. Markowitz is Director of the Multiple Sclerosis Center at the University of Pennsylvania and Professor of Neurology at the University of Pennsylvania School of Medicine in Philadelphia. His expertise is in the field of multiple sclerosis and is involved with many clinical trials developing new compounds for the treatment of MS. He currently serves as the Chairman of the Clinical Advisory Committee for the Delaware Valley chapter of the National Multiple Sclerosis Society. Dr. Markowitz is the author of a number of publications, and he serves as an ad hoc reviewer to several important scholarly publications. He is a member of the American Academy of Neurology.

Doug Arnold, M.D. – Dr. Arnold is the James McGill Professor of Neurology and Neurosurgery at the Montreal Neurological Institute of McGill University. He directs a research laboratory using world class advanced MRI acquisition and analysis techniques to improve the understanding of how brain injury and repair in MS evolve and how they are subsequently influenced by therapeutic interventions.

Edward Fox, M.D., Ph.D – Dr. Fox is the director of Multiple Sclerosis Clinic of Central Texas and is also trained as an immunologist. He is on the advisory committee for the Lone Star Chapter of the National Multiple Sclerosis Society, and is a member of the Consortium of Multiple Sclerosis Centers. Dr. Fox has been appointed Clinical Assistant Professor of Neurology for the University of Texas Medical Branch and is leading student and resident training in neuroimmunology and the role of clinical research in medical private practice.

Dawn McGuire, M.D. – Dr. McGuire is the Chair of Opexa’s Scientific Advisory Board and the Company’s acting chief medical officer. She is a board certified neurologist with more than a decade of executive leadership in drug development. Previously, Dr. McGuire was vice president of clinical research at Elan Pharmaceuticals where she served as development leader for Tysabri, a drug now marketed for the treatment of patients with relapsing forms of multiple sclerosis (MS). Dr. McGuire also holds several academic and service positions, including American Academy of Neurology committee memberships, peer review committee membership in the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH), and serves on the Advisory Council of the Gill Heart Institute.

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 therapy, Tovaxin®, is a personalized cellular immunotherapy treatment that is in clinical development for multiple sclerosis (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 Tovaxin for Early Relapsing Multiple Sclerosis (TERMS) Phase 2b 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 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.

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,” 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 current or future financial payments, returns, royalties, 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: market conditions, 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), and 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, 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 (including for Tovaxin), the risk of litigation regarding our intellectual property rights, the success of third party development and commercialization efforts with respect to products covered by intellectual property rights transferred by the Company, 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 the reports filed with the Securities and Exchange Commission.

Contacts

Opexa Therapeutics, Inc.
Neil K. Warma, 281-719-3437
nwarma@opexatherapeutics.com

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