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 registration for Intercept and expects the process to take as long as 15 months.
“The Intercept RBC CE Mark submission is a major milestone in the company’s history and represents the culmination of years of effort to complete the full Intercept portfolio of products to help ensure that patients have access to safe blood transfusions,” president & CEO William Greenman said in prepared remarks. “We are looking forward to working with the regulatory agencies in EMEA to bring this important product to market.”
“We anticipate the regulatory review process could exceed 15 months given the breadth of the submission, which covers both device and biologic elements. Our submission will be reviewed by TÜV SÜD, our notified body, and Irish Health Products Regulatory Authority, the competent authority,” added regulatory affairs & quality SVP Carol Moore.
Cerus, which in February raised $58 million with its initial public offering, in May landed a $15 million amendment to its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research & Development Authority.