Cerus Initiates Patient Enrollment in European Phase III Clinical Trials for
INTERCEPT Red Blood Cells for Acute and Chronic Anemia
CONCORD, Calif. -- June 11, 2013
Cerus Corporation (NASDAQ: CERS) announcedtoday that it has initiated patient
enrollment in two European Phase III clinical trials for the INTERCEPT System
for red blood cells (RBCs). One trial is being conducted for patients with
acute anemia, and a separate trial is being conducted for patients with
“This Cerus milestone marks an important step in our effort to provide
pathogen inactivation for RBCs, complementing the INTERCEPT Blood Systems for
platelets and plasma that are currently available in Europe and other
geographies,” said Dr. Laurence Corash, Cerus’ chief medical officer. “We
anticipate that the future availability of pathogen inactivation for all three
blood components will allow patients receiving transfusions to realize the
full benefit of the prospective protection it can provide.”
RBCs are the most frequently transfused blood component, with approximately 85
million units transfused globally each year. Surgical patients with acute
anemia, including cardiac surgery patients, are major recipients of RBC
transfusions. Chronic anemia patients, such as those with thalassemia and
sickle cell disease, are exposed to more blood transfusions than almost any
other patient group, receiving as many as 1,500 RBC units over the course of a
lifetime and thus at elevated risk for exposure to existing and emerging
pathogens as well as bacterial contamination.
Cerus is conducting these two Phase III clinical trials to support CE Mark
registration. The first clinical trial is being conducted in elective
cardiovascular surgery patients with acute anemia. Patients are randomized to
receive seven days of support, beginning on the day of surgery, with either
conventional or INTERCEPT RBCs. Target enrollment is 50 patients, and the
primary endpoint is hemoglobin content per RBC unit transfused. Hemoglobin
content was selected as the primary endpoint to evaluate the efficacy of the
INTERCEPT Blood System as it is a key requirement for RBC components for
transfusion per the European guidelines (EDQM) and will provide supporting
data for CE Mark registration per the EU Medical Device Directive.
The second clinical trial is being conducted in transfusion-dependent
thalassemia major patients with chronic anemia. Patients are randomized into a
crossover design and will receive transfusion support, separately in random
sequence, with both conventional and INTERCEPT RBCs over approximately 12
months. Target enrollment is 70 patients, and the primary endpoints are
hemoglobin usage (efficacy) and immunogenicity with repeat exposure (safety).
Hemoglobin usage was selected as the primary efficacy endpoint as it
represents the ability of transfused RBCs to oxygenate tissues, to persist in
circulation, and to suppress endogenous erythropoiesis. This endpoint is
clinically relevant because hemoglobin consumption may contribute to iron
burden, an important complication for patients despite availability of
Cerus Corporation is a biomedical products company focused on enhancing blood
safety. The INTERCEPT system is designed to reduce the risk of
transfusion-transmitted diseases by inactivating a broad range of pathogens
such as viruses, bacteria and parasites that may be present in donated blood.
The nucleic acid targeting mechanism of action enables INTERCEPT treatment to
inactivate established transfusion threats, such as hepatitis B and C, HIV,
West Nile virus and bacteria, and is designed to inactivate emerging pathogens
such as influenza, malaria and dengue. Cerus currently markets and sells the
INTERCEPT Blood System for both platelets and plasma in Europe, the
Commonwealth of Independent States, the Middle East and selected countries in
other regions around the world. In the United States, Cerus is seeking
regulatory approval of the INTERCEPT Blood System for plasma and platelets.
The INTERCEPT red blood cell system is in clinical development. See
http://www.cerus.com for more information.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
This press release contains forward-looking statements. Any statements
contained in this press release that are not statements of historical fact may
be deemed to be forward-looking statements, including, without limitation,
statements relating to the clinical development, including the timing thereof,
and commercial availability of the INTERCEPT Blood System for red blood cells.
These forward-looking statements are based upon Cerus’ current
expectations.Actual results could differ materially from these
forward-looking statements as a result of certain factors, including, without
limitation, risks and uncertainties associated with the commercialization and
market acceptance of, and customer demand for, the INTERCEPT Blood System, the
uncertain and time-consuming clinical development and regulatory process,
Cerus' ability to successfully initiate and conduct planned clinical trials in
the anticipated timeframes, or at all, and other risks detailed in
theCerus'filings with theSecurities and Exchange Commission(SEC),
including inCerus'quarterly report on Form 10-Q for the quarter ended March
31, 2013, filed with theSEConMay 3, 2013. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the
date of this press release.Cerusdoes not undertake any obligation to update
any forward-looking statements as a result of new information, future events,
changed assumptions or otherwise.
Lainie Corten, 925-288-6319
Sr Director, Global Marketing & Investor Relations
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