Data Supports Advancement of Product Development
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that its Phase 1 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 cells continued to circulate 24 hours
following transfusion. The INTERCEPT red blood cell system is a pathogen
inactivation treatment the company is developing to protect against
transmission of infectious diseases through red blood cell transfusions.
An estimated 70 million units of red blood cells are transfused
worldwide each year.
"We are pleased with the results of this study, which provide support to
advance the INTERCEPT red blood cell program into late-stage clinical
studies in pursuit of European product approval," said Dr. Laurence
Corash, Cerus' Chief Medical Officer. "The data from this study met
recommended criteria for a successful red cell recovery study and showed
significant improvement over prior generations of the technology."
The randomized, single-blind, controlled, multi-center Phase 1 clinical
trial of the INTERCEPT red blood cell system included 27 healthy
subjects at two clinical trial centers. 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. 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 88% compared to 90% 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. The half-life of the red blood cells was also evaluated,
and INTERCEPT-treated red cells were within the established reference
range of 28 to 35 days. The half-life of INTERCEPT red blood cells was
33 days compared to 40 days for control red blood cells according to the
preliminary analysis. The investigators plan to submit data from the
study for presentation at an upcoming scientific congress.
"With pathogen inactivation of platelets and plasma currently in routine
use, the advancement of our red blood cell system will offer a
comprehensive solution to transfusion-transmitted infections for all
blood products," said Claes Glassell, President and Chief Executive
Officer of Cerus. "We expect that these results will facilitate further
red blood cell partnerships like the ones currently in place with
Grifols and the German Red Cross."
Cerus has a collaborative research program with the military to develop
pathogen inactivation technology. The pre-clinical studies that enabled
this Phase I trial were supported by the U.S. Army Medical Research and
Materiel Command under contract number W81XWH-08-1-0480.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused on
commercializing the INTERCEPT Blood System to enhance 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 allows
INTERCEPT treatment to inactivate both established transfusion threats,
such as hepatitis, HIV, West Nile virus and bacteria, as well as
emerging pathogens such as influenza, malaria and dengue. Cerus
currently markets and sells the INTERCEPT Blood System for both
platelets and plasma in Europe, Russia, 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 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 and commercialization of the INTERCEPT Blood System for red
blood cells, potential future partnership opportunities available to the
company and the potential commercial value of a comprehensive solution
for transfusion-transmitted infections. Words such as "will," "expect"
and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon the
company's current expectations. Actual results could differ
materially from these forward-looking statements as a result of certain
factors, including, without limitation, risks and uncertainties
involving commercial adoption and market acceptance of the INTERCEPT
Blood System, the uncertainty of future clinical trial results, as well
as 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 September 30, 2009, filed with the SEC on
November 6, 2009. Additionally, unless the company can obtain red blood
cell project funding, it will not be able to make substantial further
progress toward INTERCEPT red blood cell commercialization. No
pathogen inactivation system has been shown to inactivate all pathogens.
The views, opinions and/or findings contained in this press release
should not be construed as an official Department of Army position,
policy or decision unless so designated by other documentation. 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