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CERUS AND BAXTER REPORT RESULTS IN TRIAL OF INTERCEPT RED BLOOD CELL SYSTEM
Companies Reach
Agreement with FDA on Pivotal Phase III Protocol
ORLANDO, Florida,
December 10, 2001 - Cerus Corporation (Nasdaq: CERS) and Baxter Healthcare
Corporation today announced results from a comprehensive analysis of the
data from their Phase Ic clinical trial for the INTERCEPT Red Blood Cell
System, a pathogen inactivation system being developed to protect against
transmission of infectious diseases through red blood cell transfusions.
The companies also announced that they reached agreement with the Food
and Drug Administration (FDA) on the protocol for their pivotal Phase
III clinical trial. This trial, which will evaluate red blood cell use
for acute transfusion support, will begin imminently.
"We are delighted
with the progress made in our red blood cell program, for which we plan
to advance directly from Phase I into pivotal Phase III trials,"
said Stephen T. Isaacs, president and chief executive officer of Cerus.
"We have been tremendously pleased with our progress on all of the
INTERCEPT Blood Systems and look forward to the near-term commercialization
of our platelet and plasma products."
The Phase Ic results
were presented by David Wages, M.D., Ph.D., medical director of the Red
Cell Program at Cerus at the American Society of Hematology meeting in
Orlando. The two-part trial enrolled 29 individuals in a crossover protocol
under which individuals were transfused in random sequence with INTERCEPT
red blood cells and conventional red blood cells which had not undergone
the pathogen inactivation process. The results of this trial showed that
INTERCEPT red blood cells demonstrated comparable survival to conventional
red blood cells, with mean half-life for both groups at 37.4 days. In
addition, the two groups showed similar mean recoveries with 81.7 ±
6.3 percent of INTERCEPT red blood cells circulating 24 hours after infusion
compared to 84.5 ± 6.2 percent of conventional red cells. The average
post-transfusion recovery for both types of red cells exceeded the commonly
accepted blood bank standard of 75 percent. In the second part of the
study, 11 subjects received full unit transfusions of 35 day-old INTERCEPT
red cells. The full unit transfusions were well tolerated.
Cerus and Baxter are
collaborating on the development of the INTERCEPT Blood Systems to enhance
the safety of blood transfusions. 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 U.S. The
companies are preparing to begin the U.S. regulatory submission process
for the INTERCEPT Plasma System, which will be followed by a CE Mark application
for this product. Baxter and Cerus intend to begin a pivotal Phase III
clinical trial of the INTERCEPT Red Blood Cell System shortly.
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 reports on Forms 10K, 10Q and other 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,
Baxter, (847) 948-3951
Director, Corporate Communications
Baxter Healthcare Corporation
(847) 948-3951
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