Press Release Details

Cerus U.S. Phase 3 Trial of Plasma Pathogen Inactivation System Moves Forward on Monitoring Board Report

November, 02 2000
Cerus Corporation (Nasdaq: CERS) today announced that it has received clearance from an independent Data and Safety Monitoring Board (DSMB) to continue its U.S. Phase 3 clinical trial of the Intercept Plasma System. The system, designed to inactivate viruses, bacteria and other pathogens in plasma intended for transfusion, is being developed by Cerus jointly with Baxter Healthcare.

The scheduled review by the DSMB provides an independent evaluation of study data to identify potential safety issues that might warrant modification or early termination of ongoing studies. Based on a review of data from the first 90 patients enrolled in the Phase 3 trial, the DSMB determined that the trial may proceed as planned.

"This first DSMB review of our Intercept Plasma System is consistent with prior DSMB reviews of our Intercept Platelet System Phase 3 trials," said Laurence Corash, M.D., vice president of medical affairs for Cerus. "We are pleased with the DSMB's conclusion and look forward to completing the Phase 3 plasma trial."

In collaboration with Baxter Healthcare, Cerus is conducting the Phase 3 clinical trial to evaluate clotting factor function in patients receiving transfusions of fresh frozen plasma treated with the Intercept Plasma System. The study covers three patient groups: patients with congenital clotting factor deficiencies, acquired clotting factor deficiencies and a disorder called thrombotic thrombocytopenic purpura.

The company also is developing pathogen inactivation systems for platelets, red blood cells and source plasma for fractionation. Recently, the company reported favorable results from a European Phase 3 trial of the Intercept Platelet System. Cerus and Baxter are preparing a CE Mark Application for that system, seeking licensure in Europe. A U.S. Phase 3 trial of the Intercept Platelet System is in progress. The Intercept Red Blood Cell System is in Phase 1 clinical trials, and the source plasma system is in preclinical development.

ABOUT CERUS

Cerus Corporation is developing medical systems and therapeutics that utilize the company's proprietary Helinx technology for targeting DNA and RNA 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 3 clinical trial of the Intercept Platelet System and is conducting further clinical trials of the Intercept Blood Systems: a U.S. Phase 3 trial for platelets, a U.S. Phase 3 trial for plasma and a Phase 1c trial for red blood cells.

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. (NYSE: BAX)

Statements in this news release regarding product development, clinical development and market 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 company's 1999 Annual Report on Form 10-K and Form S-3 filed with the SEC on October 3, 2000.

    Global Headquarters

  • 1220 Concord Avenue
  • Concord, CA US 94520
  • +1 925.288.6000

    European Headquarters

  • Stationsstraat 79-D
  • 3811 MH Amersfoort, Netherlands
  • +31 (0) 33 49 60 600