Cerus Initiates Patient Enrollment in European Phase III Clinical Trials for INTERCEPT Red Blood Cel
Cerus Initiates Patient Enrollment in European Phase III Clinical Trials for INTERCEPT Red Blood Cells for Acute and Chronic Anemia
CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (NAS: 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.
"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.
Cerus Corporation is a biomedical products company focused on enhancing blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases 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 enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate emerging pathogens such as influenza, malaria and dengue. 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, Cerus is seeking regulatory approval of the INTERCEPT Blood System for plasma and platelets. The INTERCEPT red blood cell system is in clinical development. See http://www.cerus.com for more information.
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 the clinical development, including the timing thereof, and commercial availability of the INTERCEPT Blood System for red blood cells. 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 and uncertainties associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, the uncertain and time-consuming clinical development and regulatory process, Cerus' ability to successfully initiate and conduct planned clinical trials in the anticipated timeframes, or at all, and other risks detailed in the Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' quarterly report on Form 10-Q for the quarter ended March 31, 2013, filed with the SEC on May 3, 2013. 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.
Lainie Corten, 925-288-6319
Sr Director, Global Marketing & Investor Relations
KEYWORDS: United States Europe North America California
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