Press Release Details

Cerus and Baxter Present Detailed European Phase III Results of the Intercept Platelet System.

October, 05 2000

Business Editors/Health & Medical Writers


Data Continue to Support Safety and Efficacy

of Pathogen Inactivation.

The Companies are Preparing Application for EU Approval

Cerus Corporation (Nasdaq:CERS) and Baxter Healthcare Corporation today presented results of an extensive analysis of data from the European Phase III clinical trial of the Intercept Platelet System. The system is designed to enhance the safety of platelet transfusions by inactivating viruses, bacteria, other pathogens and white blood cells.

Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies  in donated platelets. Results of the European Phase III trial supported the safety and efficacy of platelets prepared using the Intercept Platelet System for the treatment of patients with thrombocytopenia.

The Phase III results were presented by Dick van Rhenen, M.D., Ph.D., Medical Director, Blood Bank Rotterdam, the Netherlands, and lead investigator for the clinical trial at the American Society of Hematology Meeting being held in San Francisco. The 103 patient trial compared the performance of Intercept platelets to the performance of platelets prepared without pathogen inactivation. Dr. van Rhenen's presentation included both previously announced data and the results of additional statistical analysis. Dr. van Rhenen concluded that the results of the study reinforced the companies' preliminary analysis, showing comparable efficacy of Intercept platelets to that of control platelets and the preservation of platelet performance and function following pathogen inactivation with the Intercept Platelet System. Both platelet groups showed clinically acceptable levels of platelet count increment, a measure of the increase in the patient's platelet counts following transfusion. In addition, both groups showed a comparable low incidence of bleeding, low numbers of red blood cell transfusions and low incidence of acute transfusion reactions. No serious adverse events were directly attributed to the use of the Intercept Platelet System.

"These results are particularly exciting as they indicate, in a large patient population, that Intercept platelets offer the benefit of pathogen inactivation without compromising platelet performance or function," said Stephen T. Isaacs, president and chief executive officer of Cerus. "Based on these promising data as well as our earlier analysis of the Phase III data, Cerus and Baxter are preparing a CE Mark application seeking marketing approval in Europe."


Cerus Corporation is developing medical systems and therapeutics based on the company's proprietary Helinx technology for targeting DNA.

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic  to control biological replication. The company's most advanced programs are focused on systems to enhance the safety of the world's blood supply. These Intercept Blood Systems, based on the Helinx technology, are designed to inactivate viruses, bacteria and other pathogens. The Concord, California-based biopharmaceutical company, in collaboration with its development and commercialization partner Baxter Healthcare Corporation, has completed a European Phase III clinical trial of the Intercept Platelet System and is conducting further clinical trials of the Intercept Blood Systems in the United States: a Phase III trial for platelets, a Phase III trial for plasma and a Phase Ic trial for red blood cells Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.


Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International (NYSE NYSE

See: New York Stock Exchange :BAX). Baxter International, through its subsidiaries, is a global medical products and services company that provides critical therapies for people with life-threatening conditions. The company's products and services in bioscience (biopharmaceuticals and blood collection, separation and storage devices), medication delivery and renal therapy are used by health-care providers and their patients more than 100 countries.

Statements in this news release regarding product development, clinical development, regulatory activity and product potential 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 uncertainty of the timing and results of any clinical trials, action by regulatory authorities, the uncertainty of market acceptance of any products, competitive conditions, the uncertainty of future financing and other factors discussed in the companies' 1999 Annual Report on Form 10-K

Note to Editors: Helinx is a trademark of Cerus Corporation. Intercept Blood System, Intercept Platelet System, Intercept Plasma System and Intercept Red Blood Cell System are trademarks of Baxter International, Inc.

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