CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today 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 chronic anemia.
“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 chelation therapies.
ABOUT CERUS
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 the Cerus' filings with the Securities and Exchange
Commission (SEC), including in Cerus' quarterly report on Form 10-Q for
the quarter ended March 31, 2013, filed with the SEC on May 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. Cerus does not undertake any obligation to update any
forward-looking statements as a result of new information, future
events, changed assumptions or otherwise.
Source: Cerus Corporation