Vosaroxin: Phase III ongoing

Sunesis said an independent DSMB recommended continuation of the double-blind, international Phase III VALOR trial based on a safety review. The trial, which has enrolled 168 of a planned 450 patients, is comparing IV vosaroxin plus cytarabine vs. placebo plus cytarabine. The next DSMB review of interim efficacy and safety data is expected mid-2012, at which time VALOR may be stopped early for efficacy or futility, continued as planned or implemented with a one-time sample size adjustment of 225 additional evaluable patients. ...