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CERUS AND
BAXTER REPORT POSITIVE RESULTS IN TRIAL
OF INTERCEPT RED BLOOD CELLS
Companies Prepare
for Phase III Clinical Trial
SAN ANTONIO, Tex., October 17,
2001 - Cerus Corporation (Nasdaq: CERS) and Baxter Healthcare Corporation
today announced preliminary results from the Phase Ic clinical trial of
their INTERCEPT Red Blood Cell System, a pathogen inactivation system
being developed to protect against transmission of infectious diseases
through red blood cell transfusions. The results showed that INTERCEPT
red blood cells were well tolerated and demonstrated comparable recovery
and survival performance to red blood cells which had not been treated
with the pathogen inactivation process. The data were presented by Jorge
Rios, M.D., assistant medical director, American Red Cross, New England
Region at the American Association of Blood Banks Meeting being held this
week in San Antonio, Texas.
"We are pleased with the
preliminary results from this trial, which mark the completion of a very
thorough Phase I clinical program for the INTERCEPT Red Blood Cell System,"
said Stephen T. Isaacs, president and chief executive officer of Cerus.
"Based on these results and discussions with the U.S. Food and Drug
Administration, we are moving directly to Phase III trials of this product,
which we expect to begin shortly."
The two-part Phase Ic trial included
40 individuals, 29 of whom participated in a study designed to evaluate
the performance of INTERCEPT red blood cells compared to untreated red
blood cells. Preliminary results showed that mean survival of INTERCEPT
red blood cells following infusion was 62.2 days, which did not show statistical
difference to the 61.1 days of survival of untreated red blood cells.
In addition, the two groups showed comparable mean recovery, with 79.4
percent of INTERCEPT red blood cells surviving 24 hours after infusion
compared to 84.7 percent in the untreated group. The remaining 11 individuals
participated in a study to evaluate the tolerability of full transfusions
of INTERCEPT red blood cells. The data showed that INTERCEPT red blood
cells were well tolerated with no serious adverse events observed.
Cerus and Baxter are collaborating
on the development of the INTERCEPT Blood Systems to enhance the safety
of blood transfusions. The companies are seeking U.S. and European approval
of the INTERCEPT Platelet System and are conducting a Phase III clinical
trial of the INTERCEPT Plasma System.
ABOUT CERUS
Cerus Corporation is developing medical systems and therapeutics based
on its proprietary Helinx technology for controlling biological replication.
Cerus' most advanced programs are focused on systems to enhance the safety
of the blood products used for transfusion. These INTERCEPT Blood Systems,
utilizing 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 in more than 100 countries.
Statements in this news release
regarding 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 reports on Forms
10K, 10Q and other filings with the Securities and Exchange Commission.
(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.)
FOR ADDITIONAL
INFORMATION:
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- Media Contact:
- Margaret
Stanford Shubny
Director, Corporate
Communications
Baxter Healthcare Corporation
(847) 948-3951
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- Media Contact:
- Sylvia
Wheeler
Director, Corporate Communications
Cerus Corporation
(925) 288-6061
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