Opexa Therapeutics Presents Monocyte-Derived Islet Cell Research at the International Society for Stem Cell Research Annual Meeting

Insulin signaling pathways identified in monocyte-derived islets

THE WOODLANDS, TX, USA | June 16, 2008 | Opexa Therapeutics, Inc. (NASDAQ: OPXA), a cell therapy development and commercialization company, today announced a recent poster presentation at the 2008 Annual Meeting of the International Society for Stem Cell Research held in Philadelphia June 11 – 14, 2008. The poster, titled “Ex vivo differentiation of adult human peripheral blood monocyte-derived cells into functional insulin-producing cells for the treatment of diabetes” was presented Friday, June 13th by Glenn Winnier, Ph.D., Director of Stem Cell Research.

The presentation described further characterization of the Company’s monocyte-derived islet technology (MDI). Opexa has previously shown that its proprietary monocyte-derived stem cells (MDSCs) can form into islet cell-like clusters that express pancreatic specific markers, including pdx-1, insulin, glucose transporter 2, glucagon and somatostatin as determined by immunocytochemistry. Using gene array technology, upregulation of numerous genes involved in the insulin signaling pathway during the differentiation of MDSCs into MDIs were identified. The majority of the genes with increased expression were involved in insulin signal transduction pathway including insulin, insulin receptor, insulin receptor substrate, PDX1, glucagon, glucagon receptor, GLP-1 receptor, neuroD and Glut4. These results indicate that MDSCs can differentiate into functional insulin-producing cells and may provide a potentially unlimited source of islet cells for transplantation, thus helping to solve the major problems of islet availability and allogenic rejection. The generation of human monocyte-derived, insulin producing cells may be utilized as an autologous cell replacement therapy and may provide a treatment of diabetes mellitus.

Dr. Winnier commented, “Our observation of the upregulation of the insulin signaling pathways in our MDIs is encouraging evidence that these cells are differentiating into an islet-like cell in vitro.”

“Dr. Winnier’s presentation provides further support for the advancement of our adult diabetes mellitus beta-cell replacement therapy”, said David McWilliams, president and chief executive officer of Opexa. “The generation of autologous insulin-producing MDIs from the monocytes of peripheral blood represents a novel approach in regenerative therapy for the treatment of insulin-dependent diabetes.”

About Monocyte-derived Stem Cell Technology

Opexa has developed a proprietary adult stem cell technology to produce monocyte-derived stem cells (MDSC) from blood. These MDSC can be derived from a patient’s monocytes, expanded ex vivo, and then administered to the same patient. MDSC are derived from peripheral blood monocytes which when cultured under defined conditions are able to further differentiate into several cellular lineages. Molecular biology and immunohistochemical studies have shown that these MDSCs have specific markers that distinguish them from other stem cells. In addition these studies have also shown a time-dependence for the expression of these specific gene products during the growth and differentiation of MDSCs. In vitro experiments with MDSCs have shown their capacity to differentiate towards hematopoietic, epithelial, endothelial, endocrine and neuronal cells. Opexa’s focus is the further development of this monocyte-derived stem cell (MDSC) technology as a novel platform for the in vitro generation of highly specialized cells for potential application in autologous cell therapy for patients with diseases such as diabetes mellitus.

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 www.opexatherapeutics.com.

SOURCE: Opexa Therapeutics, Inc.

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