Ampligen rintatolimod: Additional Phase III data

A post hoc analysis of the double-blind, U.S. Phase III AMP-516 trial in 234 patients showed that 39% of patients receiving twice-weekly Ampligen achieved a >=25% improvement in ETT duration from baseline to week 40, the primary endpoint, vs. 23% for placebo (p=0.013). Additionally, 26% of patients receiving Ampligen achieved a >=50% improvement in ETT duration vs. 14% for placebo (p=0.028). Hemispherx said that Ampligen also led to significant improvements on the secondary endpoints of KPS and SF-36 vitality subscale scores vs. placebo. In patients who failed to improve physically, Ampligen reduced deterioration in exercise tolerance vs. placebo. Data were presented at the Biennial International Research and Clinical meeting in San Francisco. Hemispherx previously reported that Ampligen significantly improved ETT performance and duration scores at week 40 vs. placebo. The company also previously reported that patients treated with placebo had significant prolongation of QT intervals compared to patients treated with Ampligen (see BioCentury, May 10, 2004 & Dec. 6, 2010). ...