Laurence M. Corash, M.D., Chief Medical Officer of Cerus
Corporation presented information regarding the study methodology and
data from ongoing INTERCEPT Blood System haemovigilance studies during
the European Haemovigilance Seminar held February 27 and 28 in Dublin,
Ireland.
The INTERCEPT Blood System is the first and only treatment
approved for pathogen inactivation of both platelet and therapeutic
plasma components. The INTERCEPT system is designed to inactivate a
broad range of viruses, bacteria and parasites, including emerging
pathogens like West Nile virus, SARS, Chikungunya, and influenza that
may be transmitted by blood transfusion.
"We entered the European market with extensive clinical
experience, including multiple Phase III trials evaluating over 3,700
units of INTERCEPT Platelets," said Dr. Corash. "In addition, we
believe that any time a manufacturer introduces a new medical
technology, it has a responsibility to adequately establish safety in
routine use. Therefore, I am pleased to present Cerus' haemovigilance
program to the European transfusion medicine community and to report
the results from the first 7,500 transfusions evaluated. In
collaboration with our customers, we believe that we have been able to
establish an excellent safety profile for INTERCEPT Platelets."
In the Cerus haemovigilance program, INTERCEPT Platelet
transfusions were evaluated as part of multi-center post-marketing
surveillance studies designed in compliance with European standards
for systematic evaluation of blood transfusion. The studies are
designed to evaluate the product's safety profile by monitoring
recipients for side effects such as acute transfusion reactions. In
contrast to clinical studies, there are no restrictions on entry to
the haemovigilance studies, allowing evaluation of a broader range of
patients. To date, 7,500 INTERCEPT Platelet transfusions have been
analyzed, with no unexpected side effects observed. In 2007, Cerus
plans to continue the evaluation of treated platelet units and also to
extend its haemovigilance program to include transfusions of INTERCEPT
Plasma, which was awarded a CE mark in late 2006.
Further information about the European Haemovigilance Seminar can
be found on the congress website at http://www.ehndublin.eu.
About The INTERCEPT Blood System
The INTERCEPT Blood System is designed to reduce the risk of
transfusion-transmitted diseases by inactivating a broad range of
pathogens such as viruses, bacteria, parasites, and other pathogens
that may be present in donated blood intended for transfusion. The
system treats plasma and platelets using the same illumination device,
process and active compound. Approximately 60,000 INTERCEPT treated
platelet units have been transfused to date, and the technology has
been used clinically in over 40 European blood centers. The INTERCEPT
Blood System for both platelets and plasma received approval for CE
marking in Europe, and a Phase I trial of the INTERCEPT Blood System
for red blood cells is in progress in the United States.
About Cerus
Cerus Corporation is a biopharmaceutical company that develops and
commercializes novel, proprietary products in the fields of blood
safety and immunotherapy to provide safer, more effective medical
options to patients in areas of substantial unmet medical needs. In
the field of blood safety, the company is developing and
commercializing the INTERCEPT Blood System, which is based on the
company's proprietary Helinx technology and is designed to enhance the
safety of donated blood components by inactivating viruses, bacteria,
parasites and other pathogens, as well as potentially harmful white
blood cells. In the field of immunotherapy, the company is employing
its proprietary attenuated Listeria vaccine platform to develop a
series of novel therapies to treat cancer, and it is applying its
proprietary Killed But Metabolically Active technology platform in
research and development of prophylactic and therapeutic vaccines for
infectious diseases.
INTERCEPT, INTERCEPT Blood System and Helinx are trademarks of
Cerus Corporation.
This press release contains forward-looking statements. For this
purpose, any statements contained in this press release that are not
statements of historical fact may be deemed forward-looking
statements, including, without limitation, statements regarding the
evaluation and development of the Intercept Blood System. Words such
as "believes," "estimates," "expects," "plans" and similar words or
expressions or the negative of these words or expressions are intended
to identify forward-looking statements. Actual results could differ
materially from these forward-looking statements as a result of
certain factors, including, without limitation, the risks identified
in the company's filings with the Securities and Exchange Commission,
including the company's Annual Report on Form 10-K for the year ended
December 31, 2006. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date of
this press release. The company does not undertake any obligation to
update any forward-looking statements as a result of new information,
future events, changed assumptions or otherwise.
