Press Release Details

Cerus and Baxter Initiate Phase 1C Clinical Trial for Intercept Red Blood Cell System for Pathogen Inactivation

October, 25 2000
Cerus Corporation (Nasdaq: CERS) and Baxter Healthcare Corporation today announced the initiation of their Phase 1c clinical trial of the Intercept Red Blood Cell System, a proprietary system to inactivate viruses, bacteria and other pathogens in red blood cells intended for transfusion. Cerus and Baxter are jointly developing Intercept Blood Systems for red blood cells, platelets and plasma for transfusion.

"Initiation of this trial is an important step forward in the red blood cell program and will set the stage for moving the clinical program into patients," said Laurence Corash, M.D., vice president of Medical Affairs at Cerus. "Given the millions of red blood cell transfusions each year, the Intercept system for red blood cells has tremendous potential to benefit medical practice and complements our Intercept Blood Systems for platelets and plasma which are moving toward commercialization."

The trial is designed in two parts which will run in parallel. The first part, which will include 30 participants, is a randomized, crossover trial designed to compare the post-transfusion recovery and survival characteristics of Intercept pathogen-inactivated red blood cells with the recovery and survival characteristics of untreated red blood cells prepared using standard blood bank procedures. The second part will evaluate the safety and tolerability of full unit transfusions of Intercept red blood cells in ten participants.

Prior Phase 1a and 1b clinical trials of the Intercept Red Blood Cell System included 70 subjects and supported the viability of Intercept red blood cells stored for 35 days. In addition, the data demonstrated that there was no detectable immune response directed against the treated red blood cells after multiple infusions. Based on these results, the companies have moved forward with this third clinical trial.

The Intercept Red Blood Cell System has been developed to target and inactivate blood-borne pathogens while leaving the therapeutic properties of red blood cells intact. An estimated 34 million units of red blood cells are transfused worldwide each year to treat various indications ranging from severe trauma to genetic disorders.


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 systems, based on the Helinx technology, have the ability to prevent the replication of viruses, bacteria and other pathogens. The Concord, Calif.-based biopharmaceutical company, in collaboration with its development and commercialization partner Baxter Healthcare Corporation, has completed a European Phase 3 clinical trial of Intercept platelets and is conducting a U.S. Phase 3 clinical trial of Intercept platelets, a U.S. Phase 3 clinical trial of Intercept plasma and a Phase 1c clinical trial of Intercept red blood cells.


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 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 companies' 1999 Annual Reports on Form 10-K and Cerus' 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