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Opexa Therapeutics Reveals Positive Top-Line Data In Phase I/II Extension Trial With Tovaxin - Quick Facts [OPXA]
6/21/2007 9:28:36 AM Opexa Therapeutics, Inc. (OPXA) on Thursday revealed positive top-line data in an open-label Phase I/II extension clinical trial of the investigational T-cell vaccine, Tovaxin, for multiple sclerosis. In the one-year, 8-subject extension clinical trial of relapsing remitting and secondary progressive subjects, Tovaxin therapy was shown to be safe and effective.
According to the company, the per-protocol analysis of Tovaxin therapy achieved a 92% reduction in annualized relapse rate in subjects who received two treatment doses of 30 - 45 x 10 attenuated T-cells eight weeks apart and were monitored for an additional 44 weeks. The safety profile revealed only injection site mild reactions and no severe adverse reactions related to T-cell vaccination.
The company stated that both Phase I/II clinical studies have demonstrated that T-cell vaccination depletes myelin reactive T-cells in peripheral blood. In the extension study patient population, the myelin reactive T-cell frequencies were reduced by 84% and 72% at 6 and 12 months on study, respectively. Effectiveness data for the 13 RRMS subjects across the two Phase I/II trials showed an 80% reduction in ARR.
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