Press Release Details

Cerus Initiates Phase I Clinical Trial for INTERCEPT Blood System for Red Blood Cells

September, 12 2006

CONCORD, Calif. -- Cerus Corporation (NASDAQ:CERS) announced today the initiation of its Phase I clinical trial of the INTERCEPT red blood cell system, a proprietary system designed to improve blood safety by inactivating blood-borne pathogens in donated red blood cells for transfusion. The red blood cell system has been developed to target and inactivate blood-borne pathogens while leaving the therapeutic properties of red blood cells intact. An estimated 34 million units of red blood cells are transfused worldwide each year to treat various indications ranging from severe trauma to genetic disorders.

The randomized, single-blind, controlled, multi-center Phase I study of the INTERCEPT red blood cell system will enroll approximately 28 patients and compare the recovery and lifespan of autologous red blood cells prepared using a modified S-303 process with conventional, untreated red blood cells. The primary endpoint of this study is the 24-hour red blood cell recovery post-transfusion. The study is expected to be fully enrolled before year-end and to take approximately five months to complete.

"We are pleased to announce initial enrollment in this study," said Claes Glassell, President and Chief Executive Officer of Cerus. "I just returned from the International Society of Blood Transfusion congress (ISBT) and was pleased with the level of excitement around our approach of pathogen inactivation. Together with our platelet and plasma systems, this study puts us on a course to offer a comprehensive solution to improving the safety of the world's blood supply."

During last week's ISBT congress in Cape Town, South Africa, Cerus presented data (Abstract 5PS-3402) from ongoing studies on the INTERCEPT system's ability to inactivate pathogens in red blood cells using its modified S-303 treatment process. Researchers found that the process effectively inactivates bacteria, including Staphylococcus aureus and Staphylococcus epidermidis, Yersinia enterocolitica, Escherichia coli and Serratia marcescens, as well as viruses such as HIV.


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 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. 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. INTERCEPT, INTERCEPT Blood System and Helinx are trademarks of Cerus Corporation.

Statements in this news release regarding the performance, efficacy, safety and expected benefits of Cerus products and the timing or enrollment and results of the Phase I clinical trial of the INTERCEPT red blood cell system, are forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the risks and uncertainties related to the timing and results of clinical trials and other development activities, the acceptability of any data by regulatory authorities, actions by regulatory authorities and other government authorities, including the FDA and foreign counterparts, at any stage of the development or marketing process, technological advances in the medical field, additional financing activities, manufacturing, product demand and market acceptance and adoption of any products, competitive conditions, internal and external factors that could impact commercialization, and other factors discussed in the company's filings with the Securities and Exchange Commission. Cerus does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise; all forward-looking statements speak only as of the time when made. Actual results or experience could differ materially from the forward-looking statements.

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