Cerus Corporation (NASDAQ:CERS) shares jumped 4% after the company announced that the haemoglobin content (53.1g) of INTERCEPT content 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 as compare to conventional red blood cell components (55.8g).
According to Dr. Laurence Corash, Cerus' chief medical officer , 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. The data from the recent Phase 3 study met the European criteria for red blood cell components for transfusion and demonstrated sufficient haemoglobin content and in vitro quality compared to untreated red cells. The randomized, double-blind, controlled, multi-centre 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 haemoglobin content (>40 g) suitable to support transfusion. For evaluating transfusion and overall safety, the blood components were transfused to 51 cardiovascular surgery patients at two German clinical trial sites.
Cerus Corporation is basically a biomedical products company focused in the field of blood safety. Currently, Cerus markets and sells the INTERCEPT Blood System for both platelets as well as plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.Cerus think 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. 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).