CytoDyn reports 25-week Phase IIb/III data for HIV candidate

CytoDyn Inc. (OTCBB:CYDY) reported 25-week data from the double-blind, U.S. Phase IIb/III CD02 trial of PRO 140 in 52 patients with HIV infection who were failing their current HIV therapy and reiterated its plan to begin submission of a rolling BLA to FDA for the candidate by year end.

In 47 evaluable patients who completed 25 weeks of treatment with once-weekly PRO 140 plus antiretroviral therapy (ART), 81% achieved HIV-1 RNA levels of <50 copies/mL and 92% achieved HIV-1 RNA levels of <400 copies/mL. The company declined to disclose data for the placebo arm...