Press Release Details

Cerus and Baxter Report Results in Trial of INTERCEPT Red Blood Cell System; Companies Reach Agreement with FDA on Pivotal Phase III Protocol

December, 10 2001

Business Editors/Health & Medical Writers

ORLANDO, Fla.--(BUSINESS WIRE)--Dec. 10, 2001

Cerus Corporation (Nasdaq:CERS) and Baxter Healthcare Corporation today announced results from a comprehensive analysis of the data from their Phase Ic clinical trial for the INTERCEPT Red Blood Cell System, a pathogen inactivation system being developed to protect against transmission of infectious diseases through red blood cell transfusions. The companies also announced that they reached agreement with the Food and Drug Administration (FDA) on the protocol for their pivotal Phase III clinical trial. This trial, which will evaluate red blood cell use for acute transfusion support, will begin imminently.

"We are delighted with the progress made in our red blood cell program, for which we plan to advance directly from Phase I into pivotal Phase III trials," said Stephen T. Isaacs, president and chief executive officer of Cerus. "We have been tremendously pleased with our progress on all of the INTERCEPT Blood Systems and look forward to the near-term commercialization of our platelet and plasma products."

The Phase Ic results were presented by David Wages, M.D., Ph.D., medical director of the Red Cell Program at Cerus at the American Society of Hematology meeting in Orlando. The two-part trial enrolled 29 individuals in a crossover protocol under which individuals were transfused in random sequence with INTERCEPT red blood cells and conventional red blood cells which had not undergone the pathogen inactivation process. The results of this trial showed that INTERCEPT red blood cells demonstrated comparable survival to conventional red blood cells, with mean half-life for both groups at 37.4 days. In addition, the two groups showed similar mean recoveries with 81.7 +/- 6.3 percent of INTERCEPT red blood cells circulating 24 hours after infusion compared to 84.5 +/- 6.2 percent of conventional red cells. The average post-transfusion recovery for both types of red cells exceeded the commonly accepted blood bank standard of 75 percent. In the second part of the study, 11 additional subjects received full unit transfusions of 35 day-old INTERCEPT red cells. The full unit transfusions were well tolerated.

Cerus and Baxter are collaborating on the development of the INTERCEPT Blood Systems to enhance the safety of blood transfusions. A CE Mark application seeking European approval for the INTERCEPT Platelet System has been submitted and the companies have begun the regulatory submission process in the U.S. The companies are preparing to begin the U.S. regulatory submission process for the INTERCEPT Plasma System, which will be followed by a CE Mark application for this product. Baxter and Cerus intend to begin a pivotal Phase III clinical trial of the INTERCEPT Red Blood Cell System shortly.


Cerus Corporation is developing medical systems and therapeutics based on its proprietary Helinx(TM) technology for controlling biological replication. Cerus' most advanced programs are focused on systems to enhance the safety of blood products used for transfusion. The 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 Inc. (NYSE:BAX). Baxter is a global medical products and services company that, through its subsidiaries, 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.

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.

Statements in this news release regarding clinical trials, regulatory filings, 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 Forms 10K, 10Q and other filings with the Securities and Exchange Commission.

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