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CERUS AND
BAXTER REPORT POSITIVE PHASE III RESULTS
FOR THE INTERCEPT PLATELET SYSTEM
Data Support Therapeutic
Effectiveness of INTERCEPT Platelets
CONCORD, Calif., and DEERFIELD,
Ill., August 17, 2001 - Cerus Corporation (Nasdaq: CERS) and Baxter Healthcare
Corporation today reported that the primary endpoint has been successfully
met in their U.S. Phase III trial of the INTERCEPT Platelet System. The
results support the effectiveness of INTERCEPT platelets to treat and
prevent bleeding during severe thrombocytopenia, a medical condition characterized
by a persistent reduction in platelet levels. The companies are jointly
developing the INTERCEPT Platelet System, a pathogen inactivation system
being developed to protect against transmission of infectious disease
and occurrence of transfusion reactions, which may result from blood transfusions.
"We are very excited about
these results which were collected from a broad and thorough clinical
experience," said Stephen T. Isaacs, president and chief executive
officer of Cerus. "These data show that our INTERCEPT Platelet System
maintains the therapeutic performance of platelets which have undergone
pathogen inactivation using our proprietary technology. We look forward
to completing our modular PMA submission to the FDA seeking US marketing
approval of the product."
The randomized, controlled, double
blind 671-patient clinical trial was designed to evaluate the therapeutic
efficacy and safety of INTERCEPT platelets. In the trial, platelet transfusions
were administered to reduce the risk of bleeding during severe thrombocytopenia
and to treat active bleeding. The primary endpoint of the study was a
comparison of the proportion of patients with moderate bleeding (Grade
2 World Health Organization criteria) following platelet transfusion with
either INTERCEPT platelets or platelets that had not been treated with
a pathogen inactivation process. The data showed that the proportion of
patients with moderate bleeding between the patients who received INTERCEPT
platelets and control groups was statistically equivalent and within 1%
of each other, solidly achieving the trial's goal of a less than 12.5%
difference between the two groups.
The study also evaluated a number
of secondary endpoints comparing INTERCEPT platelets to untreated platelets,
including those intended to detect differences in numbers of platelets
transfused and increases in platelet counts post-transfusion. These data,
some of which showed statistically significant differences, will provide
physicians with additional information on INTERCEPT platelets. Data on
secondary endpoints are undergoing further analysis. The companies will
submit the data from this study for presentation at a forthcoming scientific
meeting.
More than four million platelet
transfusions are performed annually in Western Europe, North America and
Japan to prevent bleeding in a variety of patients, including those undergoing
cancer therapy and surgical procedures. While donated platelets are generally
tested for a limited number of specific pathogens, testing does not eliminate
the risk of viral contamination, and there are no routine tests to screen
for bacteria. Bacterial contamination in collected platelets is of particular
concern as bacteria quickly multiply in nutrient-rich platelet concentrates,
which are stored at room temperature. Also, white blood cells in platelet
transfusions can potentially result in graft-vs-host disease and other
severe immune reactions in the transfusion recipient. The INTERCEPT Platelet
System is being developed to target the nucleic acid of viruses, bacteria,
other pathogens and white blood cells to improve the safety of platelet
transfusions.
In a separate release today, the
companies announced results from the Phase IIIb trial of the INTERCEPT
Plasma System, which demonstrated that the primary endpoint of that study
also was successfully met. Cerus and Baxter also are conducting a Phase
IIIc trial for the INTERCEPT Plasma System and are preparing to begin
a Phase III trial with their 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 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 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 III trial of the
INTERCEPT Platelet System 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
Director, Corporate Communications
Baxter Healthcare Corporation
(847) 948-3951
- Media Contacts:
- Sylvia Wheeler
Director, Corporate Communications
Cerus Corporation
(925) 288-6061
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