Banking on safety

Even though its Tovaxin missed the primary endpoint in a Phase IIb trial to treat relapsing-remitting multiple sclerosis, Opexa Therapeutics Inc. thinks the autologous stem cell vaccine has a chance in RRMS. The company's confidence is based in part on a post hoc analysis of secondary endpoint data, and in part on a mechanism of action that it says should make it safer than marketed drugs.

In September, Opexa released top-line data from the one-year Phase IIb TERMS trial in 150 patients with RRMS or clinically isolated syndrome (CIS), in which Tovaxin missed the primary endpoint of cumulative number of gadolinium-enhanced brain lesions summed over weeks 28, 36, 44 and 52 compared to placebo. The vaccine showed a non-significant improvement in annualized relapse rate (ARR) vs. placebo (0.214 vs. 0.339), a secondary endpoint...