Press Release Details

Cerus and Baxter Report Additional INTERCEPT Platelet Data From European Phase III Trial

July, 16 2001
Cerus Corporation (Nasdaq: CERS) and Baxter Healthcare Corporation today announced results from the second cycle of platelet transfusions in their European Phase III clinical trial of the INTERCEPT Platelet System. These clinical trial results for patients receiving a second course of transfusions further support the safety and efficacy of platelets prepared using the INTERCEPT Platelet System. The companies are developing INTERCEPT Blood Systems to protect against transmission of infectious diseases and occurrence of immune reactions, which may result from blood transfusions.

The second cycle study involved 10 of 52 patients who had received an initial course of INTERCEPT platelets as part of the European Phase III trial and received another cycle of the pathogen-inactivated platelet transfusions during a subsequent period of thrombocytopenia, a medical condition characterized by a persistent reduction in platelet counts. The data, although not statistically powered, showed that the safety and efficacy of the second cycle, or course, of INTERCEPT platelets was comparable to the first course, with comparable increases in platelet counts following transfusion. The incidence of acute reactions was low in both courses, with comparably low incidence of refractoriness, or resistance, to the transfusion. In addition, patients did not develop detectable antibodies to INTERCEPT platelets after multiple transfusions.

The results were presented by Jean-Pierre Cazenave, M.D., medical director, Etablissement Francais du Sang, Strasbourg, France at the VIIth European Congress of the International Society of Blood Transfusion meeting in Paris.

"The European Phase III trial was designed to mirror standard clinical practice which provides multiple courses of platelet transfusions to patients who require additional support," said Dr. Cazenave. "These follow-up clinical trial results support the safety and efficacy of multiple treatments with INTERCEPT platelets and are consistent with the positive results reported last year on the first course of treatment with INTERCEPT platelets."

The companies previously announced results from the first treatment course of 103 patients in the Phase III trial, which compared the performance of INTERCEPT platelets to the performance of platelets prepared without pathogen inactivation. 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 indicated that INTERCEPT platelets offer the benefit of pathogen inactivation without compromising platelet performance or function.

More than 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 in collected platelets 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 target the nucleic acid of viruses, bacteria, other pathogens and white blood cells to improve the safety of platelet transfusions.

Cerus and Baxter also are conducting a Phase III trial for the INTERCEPT Plasma System and are preparing to begin a Phase III trial with their INTERCEPT Red Blood Cell System.


Cerus Corporation is building on its leading position in the biopharmaceutical industry by developing medical systems and therapeutics to provide safer and more effective options to patients. The company is developing products based on its proprietary Helinxâ„¢ technology for controlling biological replication. Cerus' most advanced programs are focused on systems to enhance the safety of the world's blood supply. These INTERCEPT Blood Systems, based on the company's Helinx technology, are designed to inactivate viruses, bacteria, other pathogens and white blood cells. The Concord, California-based company also is pursuing therapeutic applications of Helinx technology to treat and prevent serious diseases.


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, vaccines, biosurgery and transfusion therapies), 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 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 risks and uncertainty of the timing and results of clinical trials and other development activities, actions by regulatory authorities at any stage of the development process, additional financing activities, market acceptance of any products, competitive conditions and other factors discussed in the companies' most recent reports on Form 10Q and other filings with the Securities and Exchange Commission.

Statements in this news release regarding commercialization, regulatory process 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 or competitive conditions, the uncertainty of future financing and other factors discussed in the company's 1999 Annual Report on Form 10-K and Cerus' Prospectus dated November 1, 2000.

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