Opexa Therapeutics is a commercialization driven biotechnology cellular therapy company that develops autologous personalized cell therapies for the treatment of various diseases. The Company is focused on its proprietary stem cell and T-cell technologies for the autologous use of peripheral blood derived adult stem cells in regenerative medicine as well as T cells for the treatment of autoimmune diseases amenable to T-cell based therapies. The Company is currently developing the strategies for the use of monocyte derived stem cells (MDSC) in pre-clinical safety and effectiveness studies for the treatment of congestive heart failure (CHF) and type 1 diabetes (T1D). Cardiac tissue regeneration using MDSCs and pancreatic beta cell-differentiated MDSCs in diabetes are targeted as the first stem cell indications. The Company is currently in Phase I/II clinical trials with its novel T-cell therapy Tovaxin™ for the treatment of multiple sclerosis.
Opexa Therapeutics has obtained the exclusive, worldwide license to a technology developed by the U.S. Department of Energy's Argonne National Laboratory. This technology allows a patient to donate blood, a relatively painless and easy procedure, which is then taken to the laboratory and processed to obtain mononuclear cells. The blood is rich in mononuclear cells and a 500 ml draw contains approximately one billion of these cells. The monocytes can be dedifferentiated to pluripotent stem cells in the presence of certain growth factors to yield approximately 10 to 100 million stem cells. The resulting stem cells can be expanded and differentiated into other cell types when cultured in the presence of the appropriate growth factors. During the development of this technology the scientists at Argonne Laboratory were able to turn these monocyte derived stem cells into several different types of cells including nerve cells, liver cells, blood vessel cells, and skin cells. The importance of these stem cells is that they can be derived ex-vivo (outside of the body) from circulating monocytes drawn from an individual's blood, expanded to large quantities ex-vivo and then administered to the same patient. Because this approach to cellular therapy is an autologous system, there are no rejection issues and no need for the use of debilitating anti-rejection drugs. Autologous stem cell transfusions have been successfully used in bone marrow transplant for several years. The Company projects that these monocyte derived stem cells will be regulated as autologous "manipulated" cell therapies for "non-homologous" use. Because these stem cells are the patient's own cells, the level of regulation for autologous use may reduce the regulatory burden for pre-clinical and clinical development as compared to therapies using allogeneic ("non-self") sources of stem cells. Each patient utilizing the therapies developed by the Company will simply donate blood, which will be sent to our laboratory for processing to derive the monocyte derived stem cells. These monocyte derived stem cells will then be expanded to the appropriate therapeutic dose and returned to the physician for administration to the patient. Alternatively, the stem cells may be cryopreserved until needed for utilization as a form of treatment.
Opexa Therapeutics
2635 N. Crescent Ridge Drive
The Woodlands, TX 77381
Telephone: 281-272-9331
Fax: 281-272-1088
ir@opexatherapeutics.com
