Cerus enrolls patient in two European clinical trials for INTERCEPT System for RBCs

Jun 11 2013

Cerus Corporation (NASDAQ: CERS) announced today that it has initiated patient enrollment in two European Phase III clinical trials for the INTERCEPT System for red blood cells (RBCs). One trial is being conducted for patients with acute anemia, and a separate trial is being conducted for patients with chronic anemia.

“We anticipate that the future availability of pathogen inactivation for all three blood components will allow patients receiving transfusions to realize the full benefit of the prospective protection it can provide.”

"This Cerus milestone marks an important step in our effort to provide pathogen inactivation for RBCs, complementing the INTERCEPT Blood Systems for platelets and plasma that are currently available in Europe and other geographies," said Dr. Laurence Corash, Cerus' chief medical officer. "We anticipate that the future availability of pathogen inactivation for all three blood components will allow patients receiving transfusions to realize the full benefit of the prospective protection it can provide."

RBCs are the most frequently transfused blood component, with approximately 85 million units transfused globally each year. Surgical patients with acute anemia, including cardiac surgery patients, are major recipients of RBC transfusions. Chronic anemia patients, such as those with thalassemia and sickle cell disease, are exposed to more blood transfusions than almost any other patient group, receiving as many as 1,500 RBC units over the course of a lifetime and thus at elevated risk for exposure to existing and emerging pathogens as well as bacterial contamination.

Cerus is conducting these two Phase III clinical trials to support CE Mark registration. The first clinical trial is being conducted in elective cardiovascular surgery patients with acute anemia. Patients are randomized to receive seven days of support, beginning on the day of surgery, with either conventional or INTERCEPT RBCs. Target enrollment is 50 patients, and the primary endpoint is hemoglobin content per RBC unit transfused. Hemoglobin content was selected as the primary endpoint to evaluate the efficacy of the INTERCEPT Blood System as it is a key requirement for RBC components for transfusion per the European guidelines (EDQM) and will provide supporting data for CE Mark registration per the EU Medical Device Directive.

The second clinical trial is being conducted in transfusion-dependent thalassemia major patients with chronic anemia. Patients are randomized into a crossover design and will receive transfusion support, separately in random sequence, with both conventional and INTERCEPT RBCs over approximately 12 months. Target enrollment is 70 patients, and the primary endpoints are hemoglobin usage (efficacy) and immunogenicity with repeat exposure (safety). Hemoglobin usage was selected as the primary efficacy endpoint as it represents the ability of transfused RBCs to oxygenate tissues, to persist in circulation, and to suppress endogenous erythropoiesis. This endpoint is clinically relevant because hemoglobin consumption may contribute to iron burden, an important complication for patients despite availability of chelation therapies.

SOURCE Cerus Corporation