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CERUS
AND BAXTER PRESENT PHASE III RESULTS FOR THE INTERCEPT PLATELET AND PLASMA
SYSTEMS AT THE AMERICAN SOCIETY OF HEMATOLOGY MEETING
Data to Be Used
to Support Regulatory Submissions
ORLANDO, Florida,
December 10, 2001 - Cerus Corporation (Nasdaq: CERS) and Baxter Healthcare
Corporation today announced results of an extensive analysis of pivotal
data from two separate Phase III clinical trials of the INTERCEPT Platelet
System and the INTERCEPT Plasma System. The primary endpoints for both
trials were successfully met. The companies are jointly developing INTERCEPT
Blood Systems to protect against infectious disease transmission which
may result from blood transfusions.
The results of the Phase III INTERCEPT Platelet System trial were presented
by Jeffrey McCullough, M.D., professor of Laboratory Medicine and Pathology,
University of Minnesota, at the American Society of Hematology (ASH) meeting
being held in Orlando. The detailed analysis demonstrated that the primary
endpoint for the 671-patient trial was successfully met and the results
supported the use of INTERCEPT platelets to treat and prevent bleeding
during severe thrombocytopenia, a medical condition characterized by a
persistent reduction in platelet levels.
The primary endpoint
of the platelet trial was designed to compare the incidence of moderate
bleeding (Grade 2 World Health Organization criteria) in patients who
received INTERCEPT platelets and those receiving untreated platelets to
determine if the added feature of pathogen inactivation affected therapeutic
benefit. The data showed that the proportion of patients with moderate
bleeding was statistically equivalent between the two treatment groups
and within one percent of each other, solidly achieving the trial's goal
of a less than 12.5 percent difference in bleeding between the groups.
In addition, secondary endpoints of more severe Grade 3 or 4 bleeding
and duration of platelet support were not statistically different between
the groups. The trial data also demonstrated that INTERCEPT platelets
were associated with a statistically lower percentage of transfusion reactions
than untreated platelets. Evaluation of other secondary measures of platelet
count increment (measurements of post-transfusion platelet count increase)
and number of platelet transfusions per patient showed a statistical difference
between the INTERCEPT platelets and the untreated group, but these differences
did not affect the primary trial goal of demonstrating equivalence in
the proportion of patients with moderate bleeding between the two groups.
Adverse events and serious adverse events were not statistically different
between the groups and were consistent with expectations in the seriously-ill
patient population undergoing intensive chemotherapy.
In a separate presentation
on INTERCEPT platelets, Vic Ciaravino, Ph.D., director of Preclinical
Safety at Cerus presented results of a comprehensive preclinical safety
program. The studies were designed to evaluate safety of S-59, the active
compound in the INTERCEPT Platelet System, at dose levels that are multiples
of anticipated clinical exposures. The results of an extensive series
of studies showed no clinically relevant toxicity at exposure levels that
were 350 to 1000-fold the anticipated clinical exposure of S-59.
Also at ASH, results
of the Phase IIIb trial of the INTERCEPT Plasma System were presented
by David Ramies, M.D., director, Medical Affairs at Cerus. The 121-patient
trial evaluated the blood clotting function of patients who received INTERCEPT
plasma compared to those who received untreated plasma to determine whether
the pathogen inactivation process affected therapeutic performance. This
primary endpoint was successfully met and the results were statistically
comparable between INTERCEPT plasma and untreated plasma to treat and
prevent bleeding in patients with acquired defects in coagulation, primarily
due to end-stage liver disease. In addition, safety and adverse events
of INTERCEPT plasma compared to untreated plasma showed comparability
between the two groups.
"With these data
to support our regulatory submissions, we believe we are providing strong
packages to the FDA as we seek approval of the INTERCEPT Platelet and
Plasma Systems in the United States," said Stephen T. Isaacs, president
and chief executive officer of Cerus. "Our INTERCEPT Platelet System
is currently being reviewed by European regulators and we look forward
to beginning the submission process for the plasma system in Europe as
well."
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 United States.
Separately, the companies are preparing to begin the U.S. 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 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 pre-clinical studies, 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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