ARTICLE | Clinical News

Talactoferrin: Phase II/III discontinued

February 6, 2012 8:00 AM UTC

Agennix stopped the double-blind, international Phase II/III OASIS trial in patients with severe sepsis after an analysis by the study's DSMB showed that thrice-daily 15 mL oral talactoferrin plus standard of care (SOC) led to an increased rate of 28-day all-cause mortality, the primary endpoint, compared to placebo plus SOC. The company said it is unblinding the data in order to better understand the results and will determine its next steps after completing its review. SOC consisted of the Surviving Sepsis Campaign guidelines, which may include: IV blood pressure maintenance; medications to treat the infection; oxygen therapy; mechanical ventilation; nutritional support; and corticosteroid therapy. ...