Cerus Corporation (Nasdaq:CERS) today announced that it has filed for CE Mark registration for the Company’s INTERCEPT red blood cell (RBC) system.
“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,” said William ‘Obi’ Greenman, the Company’s president and chief executive officer. “Red blood cell transfusions are one of the most common hospital procedures globally, and there are more than 25 million red blood cell units transfused in Europe, Middle East and Africa (EMEA) annually. The INTERCEPT red blood cell system is designed to reduce the risk of transfusion transmitted infections and other potential complications such as transfusion-associated graft-versus host disease.”
“The INTERCEPT red blood cell system is an important extension to our portfolio and our existing blood center customers are excited about the opportunity to potentially safeguard all three major blood components,” continued Greenman. “We are looking forward to working with the regulatory agencies in EMEA to bring this important product to market.”
Carol Moore, Cerus’ senior vice president of regulatory affairs and quality, commented, “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.”
The CE Mark submission included a robust clinical dossier developed from Cerus’ two European Phase 3 clinical studies, STARS and SPARC.
The STARS study was a randomized, double-blinded multicenter center study evaluating the efficacy and safety of INTERCEPT RBC in acute anemia patients. Red blood cell components were transfused to cardiovascular surgery patients at two German clinical trial sites. The study met the primary endpoint, which demonstrated that the mean hemoglobin content of INTERCEPT-treated RBCs were equivalent to conventional RBCs.
The SPARC study was a randomized, double blinded cross-over study evaluating the efficacy and safety of INTERCEPT RBC in chronic anemia patients. A total of 86 thalassemia patients were enrolled at three participating international sites. Subjects were randomly assigned to a sequential treatment period of either INTERCEPT-treated RBCs or conventional RBCs with cross over to the other treatment arm upon completion of the first treatment period. Each treatment period consisted of 6 transfusion episodes. The study met the primary endpoint, which was designed to assess up to a 15% relative difference in mean consumption of hemoglobin, a measure of red blood cell efficacy and iron burden.
Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. 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.
Forward Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ CE Mark submission for the INTERCEPT red blood cell system, including the timing of regulatory review and approval thereof. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the uncertain and time-consuming regulatory process, including with respect to the label claims ultimately approved for INTERCEPT red blood cell system; that Cerus may be unable to obtain CE Mark approval, or any other regulatory approvals, of INTERCEPT red blood cell system in a timely manner or at all; that applicable regulatory authorities may disagree with Cerus’ interpretations of the data from its clinical studies and/or may otherwise determine not to approve Cerus’ regulatory submissions in a timely manner or at all, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, filed with the SEC on November 1, 2018. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.