Cerus Reports on Post-Market Surveillance Studies for the INTERCEPT Blood System at 9th European Haemovigilance Seminar
DUBLIN, Ireland--(BUSINESS WIRE)--March 1, 2007--Laurence M. Corash, M.D., Chief Medical Officer of Cerus Corporation presented information regarding the study methodology and data from ongoing INTERCEPT Blood System haemovigilance studies during the European Haemovigilance Seminar held February 27 and 28 in Dublin, Ireland.
The INTERCEPT Blood System is the first and only treatment approved for pathogen inactivation of both platelet and therapeutic plasma components. The INTERCEPT system is designed to inactivate a broad range of viruses, bacteria and parasites, including emerging pathogens like West Nile virus, SARS, Chikungunya, and influenza that may be transmitted by blood transfusion.
"We entered the European market with extensive clinical experience, including multiple Phase III trials evaluating over 3,700 units of INTERCEPT Platelets," said Dr. Corash. "In addition, we believe that any time a manufacturer introduces a new medical technology, it has a responsibility to adequately establish safety in routine use. Therefore, I am pleased to present Cerus' haemovigilance program to the European transfusion medicine community and to report the results from the first 7,500 transfusions evaluated. In collaboration with our customers, we believe that we have been able to establish an excellent safety profile for INTERCEPT Platelets."
In the Cerus haemovigilance program, INTERCEPT Platelet transfusions were evaluated as part of multi-center post-marketing surveillance studies designed in compliance with European standards for systematic evaluation of blood transfusion. The studies are designed to evaluate the product's safety profile by monitoring recipients for side effects such as acute transfusion reactions. In contrast to clinical studies, there are no restrictions on entry to the haemovigilance studies, allowing evaluation of a broader range of patients. To date, 7,500 INTERCEPT Platelet transfusions have been analyzed, with no unexpected side effects observed. In 2007, Cerus plans to continue the evaluation of treated platelet units and also to extend its haemovigilance program to include transfusions of INTERCEPT Plasma, which was awarded a CE mark in late 2006.
Further information about the European Haemovigilance Seminar can be found on the congress website at http://www.ehndublin.eu.
About The INTERCEPT Blood System
The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria, parasites, and other pathogens that may be present in donated blood intended for transfusion. The system treats plasma and platelets using the same illumination device, process and active compound. Approximately 60,000 INTERCEPT treated platelet units have been transfused to date, and the technology has been used clinically in over 40 European blood centers. The INTERCEPT Blood System for both platelets and plasma received approval for CE marking in Europe, and a Phase I trial of the INTERCEPT Blood System for red blood cells is in progress in the United States.
Cerus Corporation is a biopharmaceutical company that develops and commercializes novel, proprietary products in the fields of blood safety and immunotherapy to provide safer, more effective medical options to patients in areas of substantial unmet medical needs. In the field of blood safety, the company is developing and commercializing the INTERCEPT Blood System, which is based on the company's proprietary Helinx technology and is designed to enhance the safety of donated blood components by inactivating viruses, bacteria, parasites and other pathogens, as well as potentially harmful white blood cells. In the field of immunotherapy, the company is employing its proprietary attenuated Listeria vaccine platform to develop a series of novel therapies to treat cancer, and it is applying its proprietary Killed But Metabolically Active technology platform in research and development of prophylactic and therapeutic vaccines for infectious diseases.
INTERCEPT, INTERCEPT Blood System and Helinx are trademarks of Cerus Corporation.
This press release contains forward-looking statements. For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements, including, without limitation, statements regarding the evaluation and development of the Intercept Blood System. Words such as "believes," "estimates," "expects," "plans" and similar words or expressions or the negative of these words or expressions are intended to identify forward-looking statements. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, the risks identified in the company's filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2006. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
Cerus Corporation (U.S.)
Myesha Edwards, 925-288-6017
& Investor Relations
FIPRA International (Europe)
Francesca Mollica, 32-2-400-00-45