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Opexa Therapeutics Receives European Patent Notification for T-Cell Vaccine

Wednesday, August 08, 2007

The Woodlands, TX -- Opexa Therapeutics, Inc. (Nasdaq: OPXA), a company involved in the development and commercialization of cell therapies, today announced that it has received notification under Rule 51(4) from the Examining Division of the European Patent Office (EPO) that the EPO intends to issue a patent for "Autologous T Cell Vaccine Materials and Method." The European patent application is related to a unique method-specific approach for generating a T-cell vaccine that attacks what is believed to be the underlying cause of multiple sclerosis (MS). Rule 51(4) EPC notification is equivalent to a "Notice of Allowance" by the United States Patent and Trademark Office. It is expected that the patent will be granted within the next six months.

David McWilliams, president and chief executive officer of Opexa Therapeutics, commented, "This is an important step in advancing our intellectual property strategy for Tovaxin®, T-cell vaccine for the treatment of MS. Europe represents a significant market as we move forward with our clinical development of Tovaxin and we are pleased that our method has been recognized as being unique."

About T-cell Vaccination

For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in treated patients. Tovaxin is currently in a Phase IIb clinical trial. Patients treated in Opexa’s Phase I/II open-label studies have experienced an approximately 90% average reduction in annualized relapse rate, minimal side effects and observed improvement in average disability (EDSS) scores.

About Opexa Therapeutics

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company’s lead product, Tovaxin®, a T-cell therapy for multiple sclerosis, is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus. For more information, visit the Opexa Therapeutics website at

Safe Harbor Statement

This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

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