Swissmedic and Swiss Red Cross Present National Haemovigilance Data Showing Favourable Safety Profil
Swissmedic and Swiss Red Cross Present National Haemovigilance Data Showing Favourable Safety Profile for INTERCEPT-Treated Platelet Components
CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (NAS: CERS) announced today the results of a haemovigilance study reflecting two years of experience with routine transfusion of 62,500 INTERCEPT-treated platelet components recently presented by Swissmedic and the Swiss Red Cross at the 15th International Haemovigilance Seminar (IHS) in Brussels, Belgium.
"Swiss haemovigilance data from transfusion of INTERCEPT-treated platelet components support the favourable safety profile of this pathogen inactivated blood product compared with conventional platelets," said Dr. Markus Jutzi, Haemovigilance, Swissmedic, Swiss Agency of Therapeutic Products. "As expected, in routine use, we observed that INTERCEPT-treated platelet components prevented septic transfusion reactions. Furthermore, we detected no increased risk for pulmonary adverse events. The introduction of the INTERCEPT procedure also obviated the need for gamma irradiation."
The INTERCEPT Blood System for platelets was introduced into routine use in Switzerland in 2011, where reporting of transfusion-related adverse events is mandatory. The cumulative haemovigilance data allowed for comparison of risks associated with transfusion of conventional platelet components (during 2009-2011) and INTERCEPT-treated platelet components (during 2011-2012).
As presented at IHS, Dres. Rüesch, Jutzi and colleagues observed no change in platelet or red blood cell utilization between the two periods. There were fewer reports of non-infectious transfusion reactions in general (1:400) as well as of severe (grade 3, 4) transfusion reactions (1:10,000) with INTERCEPT-treated platelet components compared to conventional platelet components (1:300 and 1:3,000, respectively). There were no instances of septic reactions reported with INTERCEPT-treated platelet components, compared to 4 septic reactions, including 1 fatality, with conventional platelet components. Additionally, fewer and less severe transfusion reactions with respiratory symptoms were reported for INTERCEPT-treated platelet components.
"We are very pleased by the improvements in transfusion safety documented by the Swiss haemovigilance data after the adoption of the INTERCEPT Blood System for platelets, and these results are consistent with the 6-year experience in France reported by the ANSM haemovigilance system," said Dr. Laurence Corash, Cerus' chief medical officer. "Cerus' goal is to enable transfusion services to deliver safe and effective blood products to patients, and we are proud to work with countries such as Switzerland in this effort."
The poster presentation ("Two years experience with pathogen inactivation for platelet concentrates in Switzerland") is available for download on the Swissmedic website at http://www.swissmedic.ch/marktueberwachung/00159/00160/00437/index.html.
The poster abstract has been published as P-11 in Blood Transfusion, Supplement No. 1, February 2013, ISSN 1723-2007 and is available for download at http://www.bloodtransfusion.it/scarica.aspx?tipo=A&id=002454&riv=81.
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 is in the process of determining the application shell for a potential regulatory submission for the INTERCEPT Blood System for platelets. The INTERCEPT Blood System for red blood cells is in clinical development. See http://www.cerus.com for more information.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
Lainie Corten, 925-288-6319
Sr Director, Global Marketing & Investor Relations
KEYWORDS: United States Europe North America California Switzerland
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