CONCORD, Calif. - Cerus (NASDAQ:CERS) Corporation (NASDAQ:CERS) reported positive results from the ReCePI Phase 3 clinical trial for its INTERCEPT Red Blood Cells (RBCs), marking a significant step in pathogen-reduced blood transfusion therapy. The study met its primary efficacy endpoint, demonstrating that INTERCEPT RBCs are non-inferior to conventional RBCs in preventing acute kidney injury (AKI) post-transfusion, a key indicator of successful RBC tissue oxygen delivery.
In the trial, 29.3% of patients receiving INTERCEPT RBCs experienced AKI, compared to 28.0% of those receiving conventional RBCs, fitting within the non-inferiority margin with statistical significance (p=0.001). The safety profile was similar between both groups, with related treatment-emergent adverse events (TEAEs) occurring in 2.5% of INTERCEPT RBC recipients versus 0.6% for conventional RBCs (p=0.130).
Dr. Richard Benjamin, Cerus’ chief medical officer, highlighted the ReCePI trial as a pioneering effort in transfusion medicine, providing crucial insights into the efficacy and safety of pathogen-reduced RBCs. The company anticipates the integration of data from both ReCePI and the ongoing RedeS Phase 3 trial in its modular premarket approval (PMA) submission to the U.S. Food and Drug Administration (FDA), slated for initiation in the second half of 2025.
Cerus President and CEO William ‘Obi’ Greenman stated that the trial results bring the company closer to potentially offering pathogen reduction for the most commonly transfused blood component in the U.S. Cerus plans for the INTERCEPT RBCs to join its commercial portfolio, which includes INTERCEPT Systems for Platelets, Plasma, and Fibrinogen Complex.
The ReCePI trial enrolled 581 patients at 18 sites, with 321 requiring RBC transfusions. The trial was double-blinded and randomized, comparing the efficacy and safety of INTERCEPT RBCs to conventional RBCs in patients undergoing complex cardiac surgery.
Results from the ReCePI trial are expected to be presented at upcoming medical conferences and submitted for peer-reviewed publication. The development of the INTERCEPT RBC System has been partially funded by federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA.
The INTERCEPT Blood System for RBCs is designed to inactivate pathogens and donor leukocytes in RBCs intended for transfusion, preserving the therapeutic qualities of the RBCs. While the system is under development and not yet approved globally, Cerus has filed for a CE Mark in Europe and anticipates FDA submission in the U.S. in the coming years.
This news is based on a press release statement from Cerus Corporation.
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