Cerus and the Swiss Red Cross Report Successful Outcome of INTERCEPT Blood System Platelet Study
CONCORD, Calif.--(BUSINESS WIRE)--Sep 2, 2010 - Cerus Corporation (NASDAQ:CERS) announced today the successful outcome of a multi-year trial of INTERCEPT-treated platelet components conducted at the Swiss Red Cross Blood Center in Basel, Switzerland. The INTERCEPT Blood System is a pathogen inactivation treatment designed to protect against transfusion-transmitted diseases.
"This study demonstrated that INTERCEPT platelets provide adequate prophylactic support for hematology-oncology patients," said Dr. Andreas Buser, director of the Swiss Red Cross Blood Center in Basel. "The INTERCEPT platelet count increments in this study mirror what we see for conventional platelets. Our clinical experience with INTERCEPT adds evidence for the recent Swiss Red Cross decision to convert almost all of its centers to INTERCEPT in order to ensure proactive protection against bacterial contamination and emerging pathogens."
The open label experience study included platelet-deficient hematologic patients at the University Hospital Basel and was conducted to evaluate both platelet count increments and transfusion related adverse events. The corrected count increment measures the increase in the patient's platelet count following a platelet transfusion, adjusted for dose and patient blood volume.
A control arm (72 patients) provided data to compare with the data generated for INTERCEPT platelets (44 patients). The mean one-hour corrected count increment for the INTERCEPT arm compared favorably to the control arm. This was true both for the 19 patients who received only INTERCEPT platelets per protocol (15,600 INTERCEPT / 10,200 control), as well as for the 25 patients who received at least one transfusion of conventional platelets in addition to INTERCEPT platelets (intent-to-treat, 13,600 INTERCEPT / 10,200 control). Patients in the INTERCEPT arm were transfused with conventional platelets if no INTERCEPT platelets were available at the time a transfusion was required.
The investigators in Basel noted no differences in serious adverse events related to bleeding, in the number of platelet transfusions or the interval between transfusions, nor were there any reports of platelet transfusion related bacteremia or other transfusion transmitted infection. The investigators plan to submit the study data for presentation at an upcoming transfusion medicine congress.
“We are especially pleased with these clinical outcomes in the context of the economic advantages realized from obtaining 100% of INTERCEPT platelet components from double-dose splits and eliminating the need for gamma irradiation,” added Dr. Buser. “Our experience preparing INTERCEPT platelet components for this study will be shared with other Swiss Red Cross centers to streamline their deployment of the technology.”
"With over 8 years of experience in routine use, the INTERCEPT system continues to perform exceptionally well in blood center operations and in clinical practice," said Dr. Laurence Corash, Cerus' chief medical officer.
The INTERCEPT systems for platelets and plasma are used by over 60 blood centers in Europe, Russia and the Middle East. The INTERCEPT red blood cell system is in clinical development. The INTERCEPT Blood System is not yet approved for use in the United States.
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance 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 allows INTERCEPT treatment to inactivate both established transfusion threats, such as hepatitis, HIV, West Nile virus and bacteria, as well as emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, Russia, the Middle East and selected countries in other regions around the world, with over 600,000 units transfused to date. The INTERCEPT red blood cell system is in clinical development. Visit http://www.cerus.com for more information.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.
Contact: Cerus Corporation
Lainie Corten, 925-288-6319
Director, Global Communications & Marketing
Posted: September 2010