Opexa's Stem Cell Therapy for Diabetes Shows Progress

Peripheral blood cells demonstrate ability to differentiate into insulin producing pancreatic-like cells

THE WOODLANDS, TX, USA | March 17, 2009 | Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company dedicated to the development of stem cell therapies for diabetes today announced new preclinical data to support its autologous stem cell therapy program. Opexa completed confirmatory studies within its c-GMP facility showing that cells obtained from peripheral blood have the ability to differentiate into stem cells and ultimately into pancreatic-like cells. Opexa’s proprietary technology has shown that peripheral blood mononuclear cells obtained from the blood of healthy and diabetic patients can differentiate into pancreatic islet-like cells, demonstrating many of the expected characteristics of true pancreatic islet cells including the ability to secrete insulin, glucagon and somatostatin. Additional studies recently completed by Opexa’s scientists also support these findings showing high levels of C-peptide, a by-product of insulin synthesis, within these islet-like cells, as well as many key stem cell and pancreatic biomarkers.

Opexa is currently completing preclinical development and advancing toward a Phase I clinical trial for the use of its proprietary autologous stem cell therapy derived from a patient’s own blood for the treatment of diabetes. Preclinical data obtained in animal and in vitro studies to date have been encouraging and have yielded the following results:

* Opexa has derived multipotent stem cells from peripheral blood mononuclear cells obtained from the blood of both healthy and diabetic subjects. These stem cells have been differentiated into insulin-producing islet-like clusters.
* These islet-like clusters express a variety of endocrine specific markers, are composed of the key pancreatic cell types (α, β, δ), and are able to synthesize and secrete insulin in a glucose-responsive manner in vitro.
* In vivo studies involving the subcapsular kidney transplantation of these islet-like clusters into diabetic NOD/SCID mice resulted in a reduction in the blood glucose levels for prolonged periods of time.

Additional preclinical studies are planned to examine optimal dosing, delivery and route of administration of the islet-like clusters, and toxicology. Following a preliminary meeting with the FDA and through consultations with its Clinical Advisory Board, Opexa has designed a Phase I clinical study protocol. Primary endpoints are proposed to be safety of monocyte derived pancreatic-like islet cell transplantation and insulin independence or reduction in exogenous insulin requirements at one year post initial infusion.

“I am pleased to see important advances with our stem cell therapy as this technology could offer benefits not only for the treatment of diabetes but also in other disease areas,” remarked Neil K. Warma, president and chief executive officer. “We are also hopeful to be able to derive one course of treatment from a single blood draw from a diabetic patient which, ideally, would lead to a readily available source of patient-specific β-cells suitable for autologous cell transplantation.”

“We have developed a manufacturing process based on a small-scale, bag-based system which we believe should yield significant cost savings over typical embryonic stem cell and cadaveric cell manufacturing processes,” commented Donna Rill, senior vice president, Operations. “We have extensive experience with cell therapy technology having just completed a 150 patient Phase IIb clinical study with our T-cell therapy and have applied many of the same principles to our stem cell manufacturing process. Much work still remains but we are encouraged with these data.”

About Opexa

Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as multiple sclerosis, 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 is Tovaxin, a T-cell therapy for multiple sclerosis that recently completed 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

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