Company Profile
Opexa Therapeutics (Nasdaq: OPXA) is a biotechnology company dedicated to the development of patient-specific cellular therapies for the treatment of autoimmune diseases such as multiple sclerosis (MS) and diabetes. The company’s product candidates have the potential to offer enhanced efficacy, safety and tolerability to address the significant unmet medical needs in several large patient populations

Opexa’s lead product candidate is Tovaxin®, a novel T-cell vaccine for the treatment of MS that is specifically tailored to each patient’s disease profile. Opexa believes the potential combination of efficacy, superior safety, improved tolerability and administration may position Tovaxin as the MS treatment of choice as compared to existing therapeutic options.

Top-line results from the Phase IIb Tovaxin for Early Relapsing Multiple Sclerosis (TERMS) study demonstrated a positive trend in reduction in annualized relapse rate for Tovaxin-treated patients as compared to placebo, as well as an excellent safety profile with no serious adverse events related to Tovaxin treatment.

Opexa intends to complete a comprehensive analysis of all data from the TERMS study over the next several months. Based on the TERMS study results, Opexa expects to conduct a Phase II close-out meeting with the United States Food and Drug Administration during the first half of 2009. This meeting, along with the comprehensive results of the TERMS study, will provide important guidance as Opexa plans to advance Tovaxin into Phase III development.

Adult Stem Cell Program
In addition to Tovaxin, Opexa is also advancing its adult stem cell program in the area of diabetes. This technology platform enables the production of multi-potent cells generated from patients’ white blood cells and provides means to differentiate these stem cells into other tissue types such as pancreatic islets. By using an individual’s own cells, this approach may minimize threat of treatment rejection. The initial application of this program is focused on the generation of insulin-secreting pancreatic-like cells.