CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that its European Phase 3 clinical trial of red blood cells treated with the INTERCEPT Blood System for acute anemia in cardiovascular surgery patients met the primary endpoint. Preliminary analysis demonstrated that the mean hemoglobin content (53.1g) of INTERCEPT-treated red blood cell components (RBCs) on day 35 of storage met the protocol-defined criteria for equivalence based on the inferiority margin of 5g compared to conventional red blood cell components (55.8g). The investigators plan to submit data from the study for presentation at upcoming scientific congresses.
"In our prior US Phase 3 study in a similar patient population, INTERCEPT red cells were shown to be non-inferior to control red cells in 148 patients based on a composite endpoint of myocardial infarction, renal failure and death," said Dr. Laurence Corash, Cerus' chief medical officer. "The data from the recent Phase 3 study met the European criteria for red blood cell components for transfusion and demonstrated sufficient hemoglobin content and in vitro quality compared to untreated red cells. We believe that the successful results from this study, combined with data from the prior Phase 3 study, support the safety and efficacy of the INTERCEPT RBC system for CE Mark registration."
The randomized, double-blind, controlled, multi-center Phase 3 clinical trial of the INTERCEPT red blood cell system evaluated the efficacy of the INTERCEPT System to process RBCs with quality and mean hemoglobin content (>40 g) suitable to support transfusion according to the European Directorate for the Quality of Medicines (EDQM). The blood components were transfused to 51 cardiovascular surgery patients at two German clinical trial sites to evaluate transfusion efficacy and overall safety. Patients undergoing procedures for either coronary artery bypass grafting (CABG), valve repair or combined procedures received study transfusions during a 7-day treatment period that included the day of surgery and 6 days post-operatively. The patients received either INTERCEPT-treated RBCs or control RBCs not treated for pathogen inactivation.
Red blood cell components for both clinical sites were manufactured at the German Red Cross blood center in Frankfurt, and the study RBCs were stored for up to 35 days prior to transfusion. The primary endpoint of equivalence of mean hemoglobin content between INTERCEPT RBCs and conventional RBCs was met within the protocol specified 5g equivalence margin based on over 750 study RBC components manufactured. The secondary efficacy endpoints also demonstrated suitability for transfusion based on mean hematocrit of 60.4% (acceptance range: 55-70%) and mean end of storage hemolysis of 0.28% (acceptance range < 0.8%). There were no statistical differences in the adverse event rates between recipients of INTERCEPT treated and control RBCs. There were no clinically relevant trends in severe or serious treatment related adverse events by system organ class. The observed adverse events were within the expected spectrum of co-morbidity and mortality for patients of similar age and with advanced cardiovascular diseases undergoing cardiovascular surgery requiring red cell transfusion. No patients exhibited an immune response to INTERCEPT treated RBCs.
The INTERCEPT red cell system is being developed to improve blood transfusion safety due to risks of transfusion transmitted infections (TTIs) and may have the additional benefits of enhanced safety with respect to transfusion-associated graft versus host disease (TA-GVHD), with the possibility of enhanced RBC viability compared to gamma irradiated RBC components. S-303 treated RBCs contain much less plasma than conventional RBC components, and thus offer the potential for reduced plasma-mediated allergic reactions and transfusion-related acute lung injury (TRALI). Cerus recently reported the results from a US Phase 2 clinical study of the INTERCEPT red cell system in healthy blood donors, and plans to include these data in the filing for CE Mark approval anticipated in the second half of 2016.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field of blood safety. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. In the United States, the INTERCEPT platelet and plasma systems have received FDA approval. The INTERCEPT red blood cell system is in clinical development. See http://www.cerus.com for information about Cerus.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements relating to Cerus’ plan to file for CE Mark approval of the INTERCEPT Blood System for red blood cells and the anticipated timing thereof, Cerus’ belief that the results from the Phase 3 clinical trial supports CE Mark registration, Cerus’ development of the INTERCEPT Blood System for red blood cells and its therapeutic potential, as well as plans to present data regarding study results. These forward-looking statements are based upon Cerus’ current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the uncertainty of future clinical trial results, the uncertain and time-consuming regulatory process, including the risk that Cerus may never obtain regulatory approval of the INTERCEPT Blood System for red blood cells in any jurisdiction; Cerus’ need for additional capital to support its clinical development programs; and other risks detailed in Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' quarterly report on Form 10-Q for the quarter ended September 30, 2014, filed with the SEC on November 7, 2014. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Cerus does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
