Cerus launches U.S. pivotal, bids for CE Mark for Intercept red blood cell treatment

Cerus Corp. (NSDQ: CERS) this week launched a U.S. pivotal trial and filed for CE Mark approval in the European Union for its Intercept red blood cell treatment. The 600-patient Recipi study is a randomized, double-blinded, controlled, parallel group, non-inferiority, Phase III trial designed to gauge the safety and efficacy of Intercept. Subjects undergoing transfusion for acute blood loss during complex cardiac surgeries are slated to be randomized 1:1 to either transfusion with conventional red blood cells or with Intercept-treated cells. The primary outcomes are the rates of renal impairment at 48 hours, adverse events at 28 days and treatment-emergent antibodies at 75 days. The primary completion date is expected to be Jan. 31, 2020, with an estimated completion date of July 31, 2020, according to ClinicalTrials.gov. “We are pleased to have started enrollment in Recipi, our pivotal Phase III study,” chief medical officer Dr. Richard Benjamin said in prepared remarks. “This marks another important milestone in advancing our Intercept red blood cell program in the U.S.” “We always want to be at the forefront of advancing science in the field of transfusion medicine and believe Intercept has the potential to improve the safety profile for transfused RBCs,” added site investigator Dr. Tina Ipe of the Houston Methodist and Weill Cornell Medical College. In a separate release, Concord, Calif.-based Cerus said it filed for CE Mark registra...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blood Management Clinical Trials Wall Street Beat Cerus Corp. Source Type: news