BioCentury
ARTICLE | Clinical News

BiovaxID regulatory update

August 20, 2012 7:00 AM UTC

Accentia's Biovest International Inc. (OTCQB:BTVI, Tampa Fla.) subsidiary said FDA requested a second Phase III trial to support a BLA submission for BiovaxID as consolidation therapy in follicular non-Hodgkin's lymphoma (NHL). The agency requested the trial to confirm data from the Phase III BV301 trial in patients with indolent follicular B cell NHL, which showed that BiovaxID significantly improved the primary endpoint of median disease-free survival (DFS) vs. an immunogenic protein keyhole limpet hemocyanin (KLH) vaccine plus the immune stimulant GM-CSF in a subset of 177 patients who were followed for up to 80 months (see BioCentury, July 21, 2008). Biovest said it will meet with FDA within the "next several months" to work out the design of the confirmatory trial. The company could not be reached for details. ...