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BAXTER AND CERUS HALT RED BLOOD CELL CLINICAL TRIALS FOR INVESTIGATIONAL
PATHOGEN INACTIVATION SYSTEM
CONCORD, Calif. and
DEERFIELD, Ill., September 4, 2003-Cerus Corporation (NASDAQ: CERS) and
subsidiaries of Baxter International Inc. (NYSE: BAX) today announced
they are voluntarily halting Phase III trials for their pathogen-inactivated
red blood cell program. The companies made this decision as a precautionary
measure after two study patients developed antibodies to red blood cells
treated with S-303, the compound used in the companies' investigational
pathogen inactivation system for red blood cells.
The two patients who
were enrolled in the Phase III trial showed an antibody response but no
clinical adverse events after transfusion with the S-303 treated red blood
cells. The antibody response was discovered using a standard blood test
that was employed as part of the clinical protocol. Antibodies are known
to arise in transfused patients and may not be physiologically active.
The observations from
this trial do not affect the development or commercialization of the pathogen
inactivation programs for platelets and plasma, which use a different
technology and mechanism of action. The red blood cell technology employs
a compound called S-303, which is activated by the pH of blood. The platelet
and plasma technology uses a compound called S-59 (or amotosalen), which
is activated by light. There is extensive, published data on the safety
profile of the platelet and plasma technology, including the amotosalen
compound, documenting no associated antibody response.
The companies plan
to evaluate the available clinical data to determine the appropriate course
of action for their investigational pathogen inactivation system for red
blood cells.
ABOUT CERUS
Cerus Corporation is building on its leading position in the biopharmaceutical
industry by developing medical systems and therapeutics to provide safer
and more effective options to patients. The company is developing products
based on its proprietary Helinx® technology for controlling biological
replication. Cerus' most advanced programs are focused on systems to enhance
the safety of the world's blood supply. The Concord, California-based
company also is pursuing therapeutic applications of Helinx technology
to treat and prevent serious diseases.
ABOUT BAXTER
Baxter International Inc., through its subsidiaries, assists health-care
professionals and their patients with treatment of complex medical conditions,
including cancer, hemophilia, immune disorders, kidney disease and trauma.
The company applies its expertise in medical devices, pharmaceuticals
and biotechnology to make a meaningful difference in patients' lives.
Cerus has scheduled
a conference call for 10 a.m. EDT today to discuss this announcement.
Interested parties can access a live Internet broadcast at: http://www.firstcallevents.com/service/ajwz388455970gf12.html.
For those unable to listen to the live broadcast, the call will be archived
at www.cerus.com.
Helinx is a
trademark of Cerus Corporation
Statements in this
news release regarding clinical trials, regulatory filings, product development,
potential efficacy against emerging pathogens and commercial 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, rates of enrollment and results of clinical trials and other
development activities, actions by regulatory authorities at any stage
of the development process, additional financing activities, manufacturing,
market acceptance of any products, competitive conditions and other factors
discussed in the company's most recent filings with the Securities and
Exchange Commission.
FOR
ADDITIONAL INFORMATION:
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For Baxter
- Media
Contacts:
- Tanya Tyska,
847-270-4918
Deborah Spak, 847-948-2349
- Investor
Contacts:
- Neville
Jeharajah, 847-948-2875
Mary Kay Ladone, 847-948-3371
For Cerus
- Media
Contacts:
- Lorie Fiber,
323-202-1046
Joe Streng, 916-442-2331
- Investor
Contacts:
- Sylvia
Wheeler, 925-288-6061
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