Cerus Corporation (NASDAQ: CERS) today announced that the U.S. Food and
Drug Administration (FDA) has approved the INTERCEPT Blood System for
plasma. The INTERCEPT plasma system is approved for ex vivo
preparation of plasma in order to reduce the risk of
transfusion-transmitted infection (TTI) when treating patients requiring
therapeutic plasma transfusion.
The INTERCEPT Blood System inactivates a broad spectrum of enveloped
viruses, non-enveloped viruses, Gram-positive and Gram-negative
bacteria, spirochetes and parasites.
While current screening tests for a limited number of pathogens have
lowered the risks from transfusion-transmitted infections, these tests
are reactive approaches, requiring identification of specific pathogens
for which tests can then be developed and implemented. In contrast,
pathogen reduction by inactivation is a proactive safety measure-- the
process can inactivate susceptible viruses, bacteria, and parasites
present in plasma components independently of whether they have been
identified as specific blood supply risks. This is critical because
there is typically a lag between the emergence of new pathogens, and the
recognition that an additional safety intervention may be needed.
"We believe this approval to be a pivotal step toward giving U.S. blood
centers a proactive approach for protecting the plasma supply," said
William ‘Obi' Greenman, Cerus’ president and chief executive officer.
"Cerus’ 22 year commitment to improving transfusion safety has been
essential to achieving the U.S. approval for INTERCEPT plasma, and our
continued work with FDA on reaching an approval decision for the
INTERCEPT Blood System for platelets."
As the recent chikungunya, dengue fever and Ebola outbreaks have
demonstrated, pathogens continually emerge and present an ongoing threat
to public health. INTERCEPT pathogen reduction has been used in Europe
for over 10 years as a safety option for platelet and plasma components,
and more recently was made available in the U.S. under two
Investigational Device Exemption (IDE) studies. In the first study,
INTERCEPT Blood System processed platelets will be used to reduce the
risk of transfusion-transmitted dengue and chikungunya viruses, both of
which are responsible for current epidemics in the Caribbean region,
including Puerto Rico, as well as cases reported in the Southern United
States. In the second study, the INTERCEPT plasma system is being used
to prepare Ebola convalescent plasma for passive immune transfusion
therapy of acutely infected patients, providing an additional layer of
safety against pathogens that these recovered donors may have been
exposed to due recent travel in Africa. Plasma from recovered Ebola
virus patients treated with the INTERCEPT process will be used to create
a national stockpile for future patients.
"Plasma transfusions are an essential therapeutic treatment for many
patients," said Dr. Susan Stramer, vice president, scientific affairs,
Biomedical Services, American Red Cross. "Pathogens for which there are
no available screening tests continue to emerge or reemerge in the
population due to increases in travel, immigration and climate change,
thus potentially increasing risk of transmission to patients and
impacting donor availability. Pathogen reduction adds an additional
layer of safety for our plasma supply.”
“We are pleased that we can now bring INTERCEPT to the U.S. where the
idea for this technology was conceived, “ said Dr. Laurence Corash,
chief medical officer and scientific officer of Cerus. “As a physician
in San Francisco in the 1980’s we had to face our patients who had
contracted HIV from transfusions of blood products. I am grateful to now
be able to say to them that there is a proactive process to inactivate
similarly virulent pathogens in the blood supply, even if we have not
yet identified these newly emergent pathogens.”
Platelets, plasma and red blood cells do not require functional DNA or
RNA for therapeutic efficacy. However, pathogens (bacteria, viruses and
parasites) and white blood cells do require these nucleic acids in order
to replicate. The INTERCEPT Blood System targets this basic biological
difference between the therapeutic components of blood, compared to
harmful pathogens and donor white blood cells. The system uses a
proprietary molecule that when activated, binds to and blocks the
replication of DNA and RNA, preventing nucleic acid replication and
rendering the pathogen inactive.
CONFERENCE CALL
Cerus will host a conference call and webcast on Wednesday, December 17
at 8:00 AM ET to discuss the US approval for INTERCEPT plasma. To access
the live webcast, please visit the Investor Relations page of the Cerus
website at http://www.cerus.com/ir.
Alternatively, you may access the live conference call by dialing
866-235-9006 (U.S.) or 631-291-4549 (international).
A replay will be available on the company’s web site, or by dialing
855-859-2056 (U.S.) or 404-537-3406 (international) and entering
conference ID number 54511544. The replay will be available
approximately three hours after the call through December 31, 2014.
ABOUT THE INTERCEPT BLOOD SYSTEM FOR PLASMA
The INTERCEPT Blood System for plasma is comprised of single-use plasma
processing sets and an ultraviolet (UVA) illumination device for the ex
vivo preparation and storage of pathogen-reduced, whole
blood-derived or apheresis plasma. The safety and efficacy of plasma
prepared with the INTERCEPT Blood System has been evaluated in six
clinical studies including a total of over 500 patients. Routine use of
INTERCEPT plasma has been monitored in over 50,000 INTERCEPT plasma
components transfused to almost 10,000 patients in an active
hemovigilance study conducted by Cerus in Europe, and additionally in
over 150,000 INTERCEPT plasma components through France's national
hemovigilance reporting system in 2009 through 2011. For U.S. product
information, see http://www.intercept-usa.com.
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 Europe, the Commonwealth of
Independent States, the Middle East and selected countries in other
regions around the world. In the United States, the INTERCEPT Blood
System for plasma has received FDA approval, and the INTERCEPT Blood
System for platelets is under regulatory review. 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 commercialization
and market acceptance of, and customer demand for, the INTERCEPT Blood
System for plasma by U.S. blood centers, the ability of INTERCEPT
platelets to effectively address the threat of Chikungunya and dengue
entering the blood supply, the ability of INTERCEPT to effectively
mitigate the risks associated with the use of convalescent plasma to
treat patients with Ebola virus disease and the therapeutic benefits to
Ebola patients who receive convalescent plasma, and the ability to
stockpile treated plasma for future Ebola patients. 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 related to broad market adoption of the INTERCEPT
Blood System and budgetary, operational and technical challenges that
U.S. blood centers may face in adopting Cerus’ products, Cerus’ limited
resources and experience expanding commercialization of its products to
new geographies and markets, blood centers’ willingness to comply with
the clinical study protocol requirements necessary to use the INTERCEPT
Blood System for plasma or platelets for the two IDE studies,
unanticipated difficulties that Cerus may encounter in complying with
the post-approval regulatory requirements for the INTERCEPT Blood System
for plasma, 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.
Copyright Business Wire 2014