BioCentury
ARTICLE | Product Development

ALLP's course correction leads to a surprise

April 21, 1997 7:00 AM UTC

Confronted with a hitch that will add three to six months to the timeline for its NDA for LiquiVent, Alliance Pharmaceutical Corp. suspended enrollment of its Phase III trial in pediatric patients with acute respiratory distress syndrome (ARDS). Trial monitors noted a precipitous drop in mortality of control patients four months after ALLP changed its protocol, prompting the company to halt enrollment pending a review of the study.

ALLP also delayed the start of a Phase II/III ARDS trial in adults that was to have begun this summer. The company said the adult trial probably will dictate the timing of its NDA. ...