29.01.2007 14:00:00
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Cerus' INTERCEPT Blood System Receives First Approval in Germany
Cerus Corporation (NASDAQ:CERS) today announced that the Paul-Ehrlich-Institut (PEI), the agency that regulates blood components in Germany, has approved the sale of platelets treated with the INTERCEPT Blood System by a German blood center located in the University Hospital Schleswig-Holstein, Campus Lübeck. Applications are in progress for other German blood centers for similar marketing approvals. "This first approval is significant in providing a blueprint for other blood centers seeking PEI marketing approval. The dossier submitted to PEI by the Lübeck blood center contained data on the INTERCEPT Blood System that can be used as a common element in submissions by other blood centers in Germany,” said Claes Glassell, president and chief executive officer, Cerus Corporation. "This is a very important step for Cerus in commercializing the INTERCEPT blood system in Germany, the largest national market in Europe.” "Bacterial contamination is the most significant infectious risk facing platelet transfusion recipients today,” explained Dr. Peter Schlenke, Head of the Blood Donation Center of the Institute of Immunology and Transfusion Medicine, University of Lübeck School of Medicine, Lübeck, Germany. "I believe patients will benefit from the higher level of protection offered by the INTERCEPT system, and I’m pleased that Lübeck can now supply them to our local hospitals.” 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, and parasites that may be present in donated blood intended for transfusion. The system inactivates plasma and platelets using the same illumination device, process and active compound. Approximately 50,000 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 has received approval for CE marking in Europe, and a Phase I trial of the INTERCEPT Blood System for red cells is in progress in the United States. ABOUT CERUS 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. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements including references to the development and commercialization of products. Words such as "estimate," "may," "could," "expect" 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, risks associated with the timing and success of clinical trials and the commercialization of product candidates, as well as other risks detailed in the company's filings with the Securities and Exchange Commission, including the company's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 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.
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Cerus Corp. | 1,61 | 0,00% |
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