Baxter
This article was originally published in The Gray Sheet
Executive Summary
Firm initiates randomized, 200-patient, multi-center Phase III pivotal study at one site with two sites to follow shortly for the Intercept red blood cell system using Helinx pathogen inactivation technology developed by Cerus. The primary endpoint of the trial will compare Intercept processed red blood cells to red blood cells not prepared with a pathogen inactivation process. A second 50-patient pivotal study to follow "shortly" will compare Intercept cells to control red blood cells in support of patients with chronic anemia due to hereditary disorders such as sickle cell disease...