Cerus Corporation (NASDAQ:CERS) announced today that it has initiated a Phase I clinical trial of its INTERCEPT Blood System for red blood cells. Developed to improve the safety of red blood cell transfusions, the system is designed to inactivate pathogens that may be present in donated red blood cells, while preserving the blood products’ therapeutic properties. An estimated 34 million units of red blood cells are transfused worldwide each year to support patients with anemia due to trauma or a wide range of blood disorders.
The randomized, single-blind, controlled, multi-center Phase I clinical trial of the INTERCEPT red blood cell system is expected to enroll approximately 28 healthy subjects. Each subject will receive two transfusions of his own donated red blood cells in a randomized sequence, one with INTERCEPT-treated red blood cells and the other with untreated red blood cells. The clinical trial will compare the post-transfusion recovery and lifespan of INTERCEPT-treated red blood cells with conventional, untreated red blood cells. The primary endpoint of the clinical trial is the red blood cell recovery 24-hours post-transfusion. In comparison to Cerus’ previous red blood cell studies using the same proprietary S-303 compound, the current process has been designed to optimize red blood cell lifespan, while reducing potential immunogenicity. The clinical trial is expected to be completed in the second quarter of 2009.
"We are pleased to announce the initiation of this clinical trial," said Claes Glassell, President and Chief Executive Officer of Cerus. "Together with our marketed INTERCEPT platelet and plasma systems, the clinical advancement of our red blood cell system brings us closer to offering a comprehensive solution to the problem of transfusion-transmitted infections from viruses, bacteria, and parasites. We are already working on the design of a European Phase III clinical trial and have signed an agreement with the German Red Cross in Frankfurt to collaborate on commercialization of our red blood cell system."
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT Blood System is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. Cerus currently markets the INTERCEPT Blood System for both platelets and plasma in Europe, Russia, the Middle East and selected countries in other regions around the world. The Company is also pursuing regulatory approvals in the United States and other countries. The INTERCEPT red blood cell system is currently in clinical development.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Forward Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to Cerus’ plans to pursue clinical development of the INTERCEPT Blood System for red blood cells, and the enrollment and timing of thereof. Words such as "expect" and "believe" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the company's current expectations. Forward-looking statements involve risks and uncertainties. The company's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks inherent in conducting clinical trials, the costs associated with clinical trials and the sufficiency of our cash resources. These and other risk factors are discussed under "Risk Factors" in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2008. The company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.
William J. Dawson, 925-288-6053
Vice President, Finance & CFO