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Opexa Therapeutics Reports Positive Top-line Data in Phase I/II,Dose Escalation Trial with Tovaxin for Multiple Sclerosis

THE WOODLANDS, Texas--(BUSINESS WIRE)--Apr 3, 2007 - Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company involved in the development and commercialization of cell therapies, today announced positive top-line data in an open-label Phase I/II dose escalation clinical trial of the investigational T-cell vaccine, Tovaxin(TM), for multiple sclerosis. In this one-year, 10-subject dose escalation clinical trial, Tovaxin therapy was shown to be safe and effective. The "per-protocol" analysis of Tovaxin therapy achieved a 90% reduction (p = 0.0039) in annualized relapse rate (ARR) in subjects who received one of the three dosage levels; the doses were 6 - 9 x 10(6), 30 - 45 x 10(6) or 60 - 90 x 10(6) attenuated T-cells. Subjects in the study received subcutaneous injections of Tovaxin over a period of 20 weeks (0, 4, 12 and 20 weeks) and were monitored for an additional 32 weeks.

The safety profile for all dosage levels revealed no severe adverse reactions related to T-cell vaccination. With increasing dosage, an increase in mild injection site reactions was observed and these resolved within 48 hours.

All subjects currently are enrolled in an extension study to collect longitudinal safety and effectiveness data.

David McWilliams, president and chief executive officer of Opexa, commented, "We are particularly encouraged by the data from this dose escalation trial. While all three dosage levels were safe and effective, the group treated with the 30 - 45 x 10(6) T-cell dose achieved a 100% reduction in ARR. The currently enrolling Tovaxin IIb clinical trial is being conducted with the 30 - 45 x 10(6) T-cell dose."

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The Tovaxin Phase IIb clinical study will include 150 patients in a multicenter, randomized, double blind, placebo-controlled trial designed primarily to evaluate the efficacy, safety and tolerability of the Tovaxin T- cell vaccination with clinically isolated syndrome (CIS
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