CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that its Phase 2
clinical trial of red blood cells treated with the INTERCEPT Blood
System met its primary endpoint, with preliminary analysis demonstrating
that greater than 75 percent of treated red blood cells continued to
circulate 24 hours following transfusion. The investigators plan to
submit data from the study for presentation at an upcoming scientific
congress.
"We are pleased with the results of this study, which support the future
advancement of the INTERCEPT red blood cell program into a Phase 3 study
in the United States," said Dr. Laurence Corash, Cerus' Chief Medical
Officer. "The data from this study met recommended criteria for a
successful red cell recovery study and demonstrate that INTERCEPT red
cells behave similarly to untreated red cells when infused into healthy
volunteers.”
The randomized, single-blind, controlled, multi-center Phase 2 clinical
trial of the INTERCEPT red blood cell system evaluated 26 healthy
subjects at two United States clinical trial sites. Each subject
received two transfusions of the subject's own red blood cells, one
INTERCEPT-treated, and the other a control not treated for pathogen
inactivation. Red blood cell units were stored for 35 days prior to
transfusion. The primary endpoint of the clinical trial, a mean
INTERCEPT red blood cell recovery of greater than 75 percent at 24 hours
post-transfusion, was met. The INTERCEPT red blood cells had a recovery
of 83% compared to 85% for control red blood cells, and both
INTERCEPT-treated and control red blood cells met the criteria for red
blood cell recovery recommended by the U.S. Food and Drug Administration.
In Europe, Cerus recently completed a Phase 3 clinical study of the
INTERCEPT red blood cell system in patients with acute anemia and plans
to file for CE mark approval.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood safety. Cerus currently markets and sells the INTERCEPT Blood
System for both platelets and plasma in the United States, Europe, the
Commonwealth of Independent States, the Middle East and selected
countries in other regions around the world. The INTERCEPT red blood
cell system is in clinical development. See http://www.cerus.com
for information about Cerus.
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 and regulatory submissions of the INTERCEPT Blood
System for red blood cells, as well as plans to present data regarding
study results. 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 associated with the uncertainty of future
clinical trial results, the uncertain and time-consuming
regulatory process; and other risks detailed in Cerus' filings with the
Securities and Exchange Commission (SEC), including in Cerus' quarterly
report on Form 10-Q for the quarter ended September 30, 2014, filed with
the SEC on November 7, 2014. 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