Opexa Therapeutics, Inc., a company involved in the development and commercialization of cell therapies, 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, an Opexa press release stated.

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."

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.

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.