Cerus Corporation (NASDAQ:CERS) announced today that the Company has received expanded label claims for use of platelets and plasma treated with the INTERCEPT Blood System™ to prevent transfusion-associated graft-vs.-host disease (TA-GVHD) in at-risk patients. While TA-GVHD is a rare disorder, prevention is critical because it is a condition with greater than 80 percent mortality and no effective treatment options. These expanded label claims allow blood banks in Europe to use the INTERCEPT Blood System in place of gamma irradiation for the prevention of TA-GVHD. INTERCEPT is the only CE-marked alternative to gamma irradiation. The Paul Ehrlich Institute in Germany has already authorized the use of the INTERCEPT platelet system to replace gamma irradiation for prevention of TA-GVHD and Afssaps in France has made similar authorizations for both the INTERCEPT platelet and plasma systems.
“This label expansion further validates that use of INTERCEPT can improve the quality and safety of the blood supply via pathogen inactivation,” said Claes Glassell, president and CEO of Cerus Corporation. “By replacing procedures such as gamma irradiation, bacterial testing and CMV screening, INTERCEPT can save blood banks costs associated with screening and testing blood components, while reducing the risk of transfusion-related adverse events and extending the shelf-life of donated blood.”
To date more than 100,000 INTERCEPT platelet system kits have been shipped to blood banks to treat platelet components to be administered to thrombocytopenic patients in routine clinical use. No reports of TA-GVHD events related to transfusions have been reported where hematology/oncology patients at risk for TA-GVHD were supported with INTERCEPT-treated platelets without gamma irradiation.
Fresh frozen plasma is not routinely irradiated prior to transfusion. However, treatment of plasma with INTERCEPT provides additional measure of safety.
About Transfusion-Associated Graft-vs.-Host Disease
Transfusion-associated graft-vs.-host disease (TA-GVHD) is a rare but usually fatal complication of transfusion in patients who have undergone bone marrow transplant, are immune-compromised or have a high similarity between donor and recipient HLA haplotypes. In these patients following blood transfusion, donor T lymphocytes mount an inflammatory immune response against the recipient's lymphoid tissue, resulting in a mortality rate of 80 to 90 percent. There is currently no available treatment for TA-GVHD and gamma irradiation has been the mainstay for prevention. However, relying on gamma irradiation to prevent TA-GVHD has several shortcomings. Gamma irradiated platelets are not always prescribed to transfusion recipients, which poses a risk to those patients not initially diagnosed who are potentially at risk for TA-GVHD. Gamma irradiation also adds expense to blood banking operations and has been linked to reduced platelet yield after transfusion.
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 and the Middle East. 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.
Myesha Edwards, 925-288-6017
Porter Novelli Life Sciences
Jason I. Spark, 619-849-6005