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CERUS AND BAXTER
COMPLETE ENROLLMENT IN U.S. PHASE III TRIAL OF INTERCEPT PLATELET SYSTEM
Concord, Calif. and
Deerfield, Ill., January 25, 2001 - Cerus Corporation (Nasdaq: CERS) and
Baxter Healthcare Corporation today announced the completion of enrollment
in their pivotal 600-patient Phase III clinical trial of the Intercept
Platelet System in the United States. The system is being jointly developed
by Cerus and Baxter to inactivate viruses, bacteria, other pathogens and
white blood cells in platelets intended for transfusion.
The randomized, double-blind trial includes patients who receive multiple
platelet transfusions for the treatment of thrombocytopenia, a medical
condition characterized by a persistent reduction in platelet counts.
The trial is designed to compare hemostatic function (control of bleeding)
of Intercept platelets to that of control platelets, which did not undergo
pathogen inactivation.
"With the completion of enrollment in the Phase III trial in the United
States and the recent submission of a CE Mark application seeking European
approval, our Intercept platelet program is building significant momentum
towards commercialization," said Stephen T. Issacs, president and chief
executive officer of Cerus. "We look forward to the eventual commercialization
of the system and enhancing the safety of platelets for transfusion."
Over 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
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 inactivate viruses, bacteria,
other pathogens and white blood cells in donated platelets intended for
transfusion.
About Cerus
Cerus Corporation is developing medical systems and therapeutics based
on the company's proprietary Helinx technology for inactivating disease-causing
agents. Helinx is designed to target and lock DNA or RNA, and has the
ability to prevent the replication of viruses, bacteria and other pathogens
and to control cellular proliferation. 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, other pathogens and white blood cells.
The Concord, California-based biopharmaceutical company, in collaboration
with its development and commercialization partner Baxter Healthcare Corporation,
has submitted a CE Mark Application for marketing approval of the Intercept
Platelet System in Europe. In addition, the company is conducting clinical
trials of the Intercept Blood Systems in the United States: a Phase III
trial for platelets, a Phase III trial for plasma and a Phase Ic trial
for red blood cells.
About Baxter
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, regulatory activity, commercialization 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, competitive conditions,
the uncertainty of future financing and other factors discussed in the
companies' 1999 Annual Report and Form 10-K and Cerus' Prospectus dated
November 1, 2000.
FOR ADDITIONAL
INFORMATION:
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Media
Contacts:
Margaret
Stanford Shubny, Baxter
Director, Corporate Communications
(847) 948-3951
Sylvia Wheeler, Cerus
Director, Corporate Communications
(925) 288-6061
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