Pathogen inactivation trial suspended
This article was originally published in The Gray Sheet
Executive Summary
Vitex "temporarily" halts patient enrollment in a Phase III study exploring use of its Inactine pathogen inactivation system with red blood cells for an acute-only indication. The decision to suspend enrollment comes a little over a month after a data safety monitoring board cleared the trial despite antibody problems found in Vitex' earlier Phase III trial, which supported a chronic infusion claim (1"The Gray Sheet" Oct. 18, 2004, In Brief). The latter trial was halted a year ago. The acute-only study was suspended because of one patient's immune response to Inactine-treated red cells, Vitex says. Antibody issues also have posed hurdles to clinical development of Baxter/Cerus' Intercept...