Press Release Details

Cerus Phase 3 Intercept Platelet System Trials Move Forward on Favorable Monitoring Board Report

April, 27 2000
Cerus Corporation (NASDAQ: CERS), a pioneer in systems to improve blood safety, today announced that it has received clearance from an independent Data and Safety Monitoring Board to continue its Phase 3 clinical trials of the Intercept system for inactivating viruses, bacteria and other pathogens in platelets. The company, in collaboration with Baxter Healthcare Corporation (NYSE: BAX), is developing the Intercept™ Blood Systems to protect against the transmission of infectious diseases through blood transfusions. Intercept is the only pathogen inactivation system for platelets to enter human clinical trials.

The scheduled review by the Data and Safety Monitoring Board (DSMB) is intended to provide an independent evaluation of study data to identify potential safety or efficacy issues that might warrant modification or early termination of ongoing studies. The DSMB reviewed study data from 80 of the 100 patients who received platelets as part of the European trial. The study data includes information on the ability of platelets treated with the Intercept system to control bleeding and the platelet count increments following transfusion of these products—the primary endpoint for the clinical study in Europe. This was the third and final independent review of Cerus' interim data from the European trial. Cerus and Baxter have completed enrollment of the European trial and are now following the final patients through the transfusion cycle.

The DSMB also reviewed study data from the first 60 of 600 patients enrolled in the U.S. Phase 3 trial. The initial review of data from the U.S. study focused on the safety of platelets treated with the Intercept system and the ability to control bleeding.

"This third report from the DSMB is particularly important because it provided the first review of data from the U.S. trial including the study's primary endpoint—the incidence of bleeding in two treatment groups," said Dr. Laurence Corash, Vice President of Medical Affairs for Cerus. "We are pleased that the DSMB report supports the continuation of our studies in the United States and Europe."

Cerus and its partner Baxter are developing the Intercept Blood Systems for platelets, fresh frozen plasma (FFP) and red blood cells. The Intercept Blood Systems are intended to target and inactivate blood-borne pathogens such as HIV and hepatitis B and C, as well as leukocytes, while leaving the therapeutic properties of the blood components intact. An estimated four million units of platelets are transfused annually worldwide to prevent bleeding in patients, including those undergoing cancer therapy and surgical procedures. Intercept Blood Systems are the first application of Cerus' Helinx™ technology.

In addition to the Phase 3 clinical trials for platelets, Cerus is currently conducting a Phase 3 clinical trial of the Intercept Plasma System and a Phase 1 clinical trial of the Intercept Red Blood Cell System. Cerus is also conducting a Phase 1 clinical trial of Helinx T-cells in its allogeneic cellular immunotherapy program (ACIT) to improve the outcome of bone marrow transplantation procedures.


Cerus Corporation is developing pioneering technologies to improve the safety of the world's blood supply. These technologies are based on Cerus' Helinx technology which has the ability to prevent the replication of viruses, bacteria and other pathogens and to control cellular proliferation. The Concord, Calif.-based biopharmaceutical company is currently conducting the first human clinical trials of pathogen inactivated platelets, as well as clinical trials of fresh frozen plasma (FFP) and red blood cells, in collaboration with Baxter Healthcare Corporation. Cerus continues to build upon the achievements of its founders and scientists and is exploring new applications for the company's proprietary technologies in its effort to address a number of worldwide health concerns including blood safety, cancer and hematologic disorders. For more information about Cerus, visit or call (925) 603-9071.

Helinx is a trademark of Cerus Corporation
Intercept is a trademark of Baxter International, Inc.

Statements in this news release regarding product development, clinical development and potential therapeutic applications of our product candidates are forward-looking statements that involve risk and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including the fact that interim results are not necessarily indicative of the outcome of any clinical trial, the uncertainty of timing and results of any clinical trials, regulation by the FDA, the uncertainty of replication of animal data in humans, the uncertainty of market acceptance of any products, competitive conditions, the uncertainty of future financing and other factors discussed in the company's 1999 Annual Report on Form 10-K

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