Cerus Initiates Phase I Clinical Trial for CRS-100.

Bacteria-based Immune Therapy Targets Liver Metastases 

CONCORD, Calif. -- Cerus Corporation (NASDAQ:CERS) announced today that the first patient has been dosed in a Phase I clinical trial of CRS-100, the company's lead immunotherapy product. The primary objectives of the study are to determine the maximum tolerated dose and to explore the safety profile of a single dose of CRS-100 in adult patients with cancer that has metastasized to the liver.

CRS-100 is a proprietary attenuated strain of Listeria monocytogenes that has been designed by Cerus to increase safety margins while preserving its potential to trigger a powerful immune response.

"The initiation of this Phase I clinical trial marks a significant milestone in our immunotherapy programs," said Claes Glassell, president and chief executive officer. "We expect that the data from this Phase I clinical trial will support further clinical studies involving CRS-100 and our other immunotherapy programs that are currently in development, including those Listeria-based clinical candidates that express tumor-associated markers."

The multi-center, open-label, single-injection, dose escalation clinical trial is designed to explore safety and tolerability of CRS-100 in volunteer patients who have carcinoma, refractory to standard treatment (or for whom no standard treatment is available), and who additionally have liver metastases. The trial is currently being conducted at two centers in the United States.

Liver metastases arise from a number of cancers, including colon and pancreas cancers. Colorectal cancer, which is the second most common cause of cancer death in the United States, often metastasizes to the liver, contributing to its morbidity. Despite recent advances, metastasized colorectal and pancreatic cancers remain significant unmet medical needs.

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 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 results of the Phase I clinical trial of CRS-100, 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.