VI Technologies gets US nod for INACTINE trials:
This article was originally published in Clinica
Executive Summary
The US FDA has given VI Technologies the go-ahead to start its pivotal phase III clinical trial programme for its INACTINE pathogen reduction red blood cell system. Researchers will assess the safety and effectiveness of red blood cells in two concurrent studies - one involving patients requiring acute transfusion support, and another involving those who need chronic transfusion support. "The trial designs support our goal of commercialising a system that combines broad pathogen inactivation, red cell purity, storage for 42 days and indications for use consistent with licensed red blood cells," said John Barr, the Watertown, Massachusetts firm's president and CEO.