|
CERUS AND
BAXTER REPORT ADDITIONAL INTERCEPT PLATELET DATA FROM EUROPEAN PHASE III
TRIAL
Results Support
Safety and Efficacy of INTERCEPT Platelet System
PARIS, France, July 16, 2001 - Cerus Corporation (Nasdaq: CERS)
and Baxter Healthcare Corporation today announced results from the second
cycle of platelet transfusions in their European Phase III clinical trial
of the INTERCEPT Platelet System. These clinical trial results for patients
receiving a second course of transfusions further support the safety and
efficacy of platelets prepared using the INTERCEPT Platelet System. The
companies are developing INTERCEPT Blood Systems to protect against transmission
of infectious diseases and occurrence of immune reactions, which may result
from blood transfusions.
The second cycle study involved 10 of 52 patients who had received an
initial course of INTERCEPT platelets as part of the European Phase III
trial and received another cycle of the pathogen-inactivated platelet
transfusions during a subsequent period of thrombocytopenia, a medical
condition characterized by a persistent reduction in platelet counts.
The data, although not statistically powered, showed that the safety and
efficacy of the second cycle, or course, of INTERCEPT platelets was comparable
to the first course, with comparable increases in platelet counts following
transfusion. The incidence of acute reactions was low in both courses,
with comparably low incidence of refractoriness, or resistance, to the
transfusion. In addition, patients did not develop detectable antibodies
to INTERCEPT platelets after multiple transfusions.
The results were presented by Jean-Pierre Cazenave, M.D., medical director,
Etablissement Francais du Sang, Strasbourg, France at the VIIth European
Congress of the International Society of Blood Transfusion meeting in
Paris.
"The European Phase III trial was designed to mirror standard clinical
practice which provides multiple courses of platelet transfusions to patients
who require additional support," said Dr. Cazenave. "These follow-up
clinical trial results support the safety and efficacy of multiple treatments
with INTERCEPT platelets and are consistent with the positive results
reported last year on the first course of treatment with INTERCEPT platelets."
The companies previously announced results from the first treatment course
of 103 patients in the Phase III trial, which compared the performance
of INTERCEPT platelets to the performance of platelets prepared without
pathogen inactivation. Both platelet groups showed clinically acceptable
levels of platelet count increment, a measure of the increase in the patient's
platelet counts following transfusion. In addition, both groups showed
a comparable low incidence of bleeding, low numbers of red blood cell
transfusions and low incidence of acute transfusion reactions. No serious
adverse events were directly attributed to the use of the INTERCEPT Platelet
System. These results indicated that INTERCEPT platelets offer the benefit
of pathogen inactivation without compromising platelet performance or
function.
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 designed to target the nucleic
acid of viruses, bacteria, other pathogens and white blood cells to improve
the safety of platelet transfusions.
Cerus and Baxter also are conducting a Phase III 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 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 Helinxä technology for controlling biological
replication. Cerus' most advanced programs are focused on systems to enhance
the safety of the world's blood supply. 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 International, through its
subsidiaries, is a global medical products and services company that 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 Form 10Q and other filings with the Securities and Exchange Commission.
FOR ADDITIONAL
INFORMATION:
 |
- Media Contacts:
- Margaret
Stanford Shubny,
(847) 948-3951
Director, Corporate
Communications
Baxter Healthcare Corporation
Media Contacts:
- Sylvia
Wheeler,
(925) 288-6061
Director, Corporate
Communications
Cerus Corporation
|
| |
|