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CERUS AND
BAXTER INITIATE CLINICAL SITE IN PIVOTAL PHASE III TRIAL FOR INTERCEPT
RED BLOOD CELL SYSTEM
CONCORD, Calif., and
DEERFIELD, Ill., January 9, 2002 -- Cerus Corporation (Nasdaq: CERS) and
Baxter Healthcare Corporation today announced they have initiated the
first clinical trial site for their pivotal Phase III clinical trial of
the INTERCEPT Red Blood Cell System and have received Institutional Review
Board (IRB) approvals at two other clinical trial sites. Last quarter,
the companies received U.S. Food and Drug Administration concurrence on
this acute protocol, and with IRB approvals now in place, the first transfusions
are expected to begin shortly. The INTERCEPT Red Blood Cell System is
being developed to protect against transmission of infectious diseases
through red blood cell transfusions.
"Initiating the first clinical
trial site for this Phase III trial is a significant milestone and clearly
demonstrates our leadership in addressing the substantial red blood cell
market," said Stephen T. Isaacs, president and chief executive officer
of Cerus. "We maintain a unique position in the industry with the
INTERCEPT Blood Systems, the only technology in late-stage development
for all three blood components: platelets, plasma and red blood cells."
The multi-center, double-blind,
randomized Phase III protocol is expected to enroll approximately 200
patients requiring acute red blood cell support as a result of cardiac
surgery. The primary endpoint of the trial is a comparison of the clinical
performance of INTERCEPT red blood cells to control red blood cells, which
are not prepared with a pathogen inactivation process.
The acute Phase III protocol is
one of two pivotal trials the company intends to conduct for the INTERCEPT
Red Blood Cell System. The second trial, which is expected to be initiated
shortly, will be a 50 patient trial to compare the use of INTERCEPT red
blood cells to control red blood cells in support of patients with chronic
anemia due to hereditary disorders such as sickle cell disease or thalassemia.
Red blood cells are disc-shaped
cells containing hemoglobin, which enables the cells to deliver oxygen
from the lungs to the rest of the body. Red blood cells are the most frequently
transfused blood component, with an estimated 30 million units being transfused
each year in North America, Europe and Japan. Patients typically receive
red blood cell transfusions to offset blood loss after severe accidents
and during surgery, or to increase hemoglobin levels in patients with
anemia.
Cerus and Baxter are collaborating
on the development of INTERCEPT Blood Systems to enhance the safety of
blood transfusions. In addition to the INTERCEPT Red Blood Cell System,
Cerus and Baxter are developing pathogen inactivation systems for platelets
and plasma. 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 United States. The companies are preparing to
begin the US regulatory submission process for the INTERCEPT Plasma System,
which will be followed by a CE Mark application for this product.
ABOUT CERUS
Cerus Corporation is developing medical systems and therapeutics based
on its proprietary Helinxä 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.
ABOUT BAXTER
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.
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 filings
with the Securities and Exchange Commission.
FOR ADDITIONAL
INFORMATION:
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- Media Contacts:
- Sylvia
Wheeler
Director,
Corporate Communications
Cerus Corporation
(925) 288-6061
Margaret Shubny
Director, Corporate Communications
Baxter Healthcare Corporation
(847) 948-3951
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