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CERUS AND
BAXTER REPORT PRIMARY ENDPOINT MET IN
U.S. PHASE III TRIAL OF THE INTERCEPT PLASMA SYSTEM
Data Supports Submission
for US Regulatory Approval
CONCORD, Calif., and
DEERFIELD, Ill., August 17, 2001 - Cerus Corporation (Nasdaq: CERS) and
Baxter Healthcare Corporation today reported that the INTERCEPT Plasma
System successfully met the primary endpoint of their US Phase IIIb clinical
trial. These data further support the safety and therapeutic effectiveness
of plasma treated with the INTERCEPT Plasma System, which is being developed
to protect against transmission of infectious diseases that may result
from plasma transfusions.
"These results are significant
because they demonstrate that we can offer the pathogen inactivation process
with the INTERCEPT Plasma System while maintaining therapeutic performance,"
said Stephen T. Isaacs, president and chief executive officer of Cerus.
"These results will be added to our arsenal of data supporting the
safety and efficacy of the INTERCEPT Plasma System, including preclinical
studies demonstrating inactivation of a broad spectrum of blood borne
pathogens."
The multicenter randomized, controlled,
double blind Phase IIIb trial included 121 patients with acquired defects
in coagulation, primarily due to end-stage liver disease. These patients
generally require plasma support during surgery or other invasive procedures,
including liver transplantation. The trial evaluated the blood clotting
function of INTERCEPT plasma compared to untreated plasma to determine
whether the pathogen inactivation treatment process affected therapeutic
performance. Blood clotting function was measured using prothrombin (PT)
and partial thromboplastin (PTT) times, widely used measures of blood
clotting function. The primary endpoint of the trial was a comparison
of PT and PTT responses between INTERCEPT plasma and untreated plasma
during a seven-day treatment period. The results, which achieved the trial's
statistical threshold, showed that the ability of INTERCEPT plasma to
treat bleeding was statistically comparable to that of untreated plasma.
In addition, the safety profile of INTERCEPT plasma was comparable to
untreated plasma. Data measuring secondary endpoints, examined in later
transfusions, is still being analyzed. The companies will submit data
from this study for presentation at a forthcoming scientific meeting.
Approximately seven million plasma
transfusions are performed annually in Western Europe, North America and
Japan to overcome blood-clotting deficiencies and to facilitate healing.
While donated plasma is generally tested for a limited number of specific
pathogens, testing does not eliminate the risk of viral contamination.
The INTERCEPT Plasma System is being developed to enhance the safety of
plasma transfusions by targeting the nucleic acid of a broad spectrum
of viruses, bacteria, other pathogens and white blood cells. The companies
are currently conducting a 30-patient Phase IIIc trial to evaluate INTERCEPT
plasma to treat thrombotic thrombocytopenic purpura, a sporadic disease
that requires repeated total blood volume plasma exchange to achieve remission.
Cerus and Baxter are collaborating
on the development of the INTERCEPT Blood Systems to enhance the safety
of blood transfusions. In a separate release today, the companies announced
that the primary endpoint had been met in the US Phase III clinical trial
of the INTERCEPT Platelet System. The companies also are preparing to
begin a Phase III trial for the INTERCEPT Red Blood Cell System.
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 the blood products used for transfusion. These 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 (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 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.
More detailed information on the results of the Phase IIIb INTERCEPT Plasma
System trial are contained in a report on Form 8-K, being filed with the
Securities and Exchange Commission by Cerus concurrently with this news
release.
FOR ADDITIONAL
INFORMATION:
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- Media Contacts:
- Margaret
Stanford Shubny, (847) 948-3951
Director, Corporate Communications
Baxter Healthcare Corporation
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- Media Contacts:
- Sylvia Wheeler,
(925) 288-6061
Director, Corporate Communications
Cerus Corporation
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