Press Release Details

Cerus and Baxter Complete Enrollment in U.S. Phase III Trial of Intercept Platelet System

January, 25 2001
Cerus Corporation (Nasdaq: CERS) and Baxter Healthcare Corporation today announced the completion of enrollment in their pivotal 600-patient Phase III clinical trial of the Intercept Platelet System in the United States. The system is being jointly developed by Cerus and Baxter to inactivate viruses, bacteria, other pathogens and white blood cells in platelets intended for transfusion.

The randomized, double-blind trial includes patients who receive multiple platelet transfusions for the treatment of thrombocytopenia, a medical condition characterized by a persistent reduction in platelet counts. The trial is designed to compare hemostatic function (control of bleeding) of Intercept platelets to that of control platelets, which did not undergo pathogen inactivation.

"With the completion of enrollment in the Phase III trial in the United States and the recent submission of a CE Mark application seeking European approval, our Intercept platelet program is building significant momentum towards commercialization," said Stephen T. Issacs, president and chief executive officer of Cerus. "We look forward to the eventual commercialization of the system and enhancing the safety of platelets for transfusion."

Over four million platelet transfusions are performed annually in Western Europe, North America and Japan to prevent bleeding in a variety of patients, including those undergoing cancer therapy and surgical procedures. While donated platelets are generally tested for a limited number of specific pathogens, testing does not eliminate the risk of viral contamination, and there are no routine tests to screen for bacteria. Bacterial contamination is of particular concern as bacteria quickly multiply in nutrient-rich platelet concentrates, which are stored at room temperature. Also, white blood cells in platelet transfusions can potentially result in graft-vs.-host disease and other severe immune reactions in the transfusion recipient. The Intercept Platelet System is designed to inactivate viruses, bacteria, other pathogens and white blood cells in donated platelets intended for transfusion.


Cerus Corporation is developing medical systems and therapeutics based on the company's proprietary Helinx technology for inactivating disease-causing agents. Helinx is designed to target and lock DNA or RNA, and has the ability to prevent the replication of viruses, bacteria and other pathogens and to control cellular proliferation. 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 submitted a CE Mark application for marketing approval of the Intercept Platelet System in Europe, and has completed enrollment in a 600 patient U.S. Phase III clinical trial in the United States. In addition, the company is conducting clinical trials of the Intercept Blood Systems in the United States: a Phase III trial for plasma and a Phase Ic trial for red blood cells. The company also is collaborating with the Pharmaceutical Division of Kirin Brewery Co., Ltd. in the field of oncology to develop Helinx T-cells for therapeutic use with stem cell transplantation in Cerus' allogeneic cellular immunotherapy (ACIT) program.


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

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.

Statements in this news release regarding product development, clinical development, regulatory activity, commercialization 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 and Form 10-K and Cerus' Prospectus dated November 1, 2000.

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