CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) today provided an update on the timeline
for the INTERCEPT Blood System for Red Blood Cells (RBCs) in Europe. The
target timing for CE Mark submission has been extended, and the
company’s European red cell study in chronic anemia patients has
completed enrollment.
Due to the need for additional time to complete quality control tests on
the Chemistry, Manufacturing, and Control (CMC) registration lots
required for regulatory submission, the company now plans to provide an
update on new submission timing on its 4Q16 earnings call in early
March. The CE Mark process for the INTERCEPT Blood System for Red Blood
Cells includes review and approval by both TŰV SŰD as the Notified Body
and Irish Health Products Regulatory Authority (HPRA) as the Competent
Authority. Accordingly, a new submission filing date will need to be
scheduled with TŰV SŰD Product Service GmbH.
Cerus’ SPARC trial (A Randomized Controlled Study to Evaluate
Efficacy and Safety of INTERCEPT Treated Red Blood Cells in Subjects
with Thalassemia Major Requiring Chronic RBC Transfusion) has now
reached its enrollment target of at least 70 evaluable patients, and the
company expects that study data will be available in time to support its
anticipated European product launch. The SPARC study is being conducted
in transfusion-dependent thalassemia major patients, an inherited blood
disorder of abnormal hemoglobin resulting in excessive destruction of
red blood cells.
“Chronic anemia patients such as those with thalassemia major and sickle
cell disease require more blood transfusions than almost any other
patient group, putting them at elevated lifetime risk for exposure to
existing and emerging pathogens,” said Richard Benjamin, Cerus' chief
medical officer. “Our ability to provide safety and efficacy data
generated by the chronic anemia study at the time of our anticipated
product launch will be an important supplement to the clinical data
already included for submission.”
The SPARC study is a randomized, crossover trial in which patients
receive two periods of transfusion support, consisting of one period
each of conventional and INTERCEPT-treated RBCs over approximately 6 - 9
months in total. The primary efficacy endpoint is hemoglobin usage and
the primary safety endpoint is immunogenicity. Hemoglobin usage was
selected as the primary efficacy endpoint because it is correlated with
the ability of transfused red blood cells to oxygenate tissues, persist
in circulation, and suppress endogenous erythropoiesis. This endpoint is
clinically relevant because hemoglobin consumption is correlated with
iron burden, an important complication for patients despite availability
of chelation therapies.
Red blood cells are disc-shaped cells containing hemoglobin which
deliver oxygen from the lungs to all body tissues. Red blood cells are
the most frequently transfused blood component, with over 80 million
units transfused globally each year. Patients typically receive red
blood cell transfusions to offset blood loss after trauma and during
surgery, or to increase hemoglobin levels in patients with hereditary
anemia.
ABOUT THE INTERCEPT BLOOD SYSTEM FOR RED BLOOD CELLS
Cerus reported positive results of the INTERCEPT Blood System for Red
Blood Cells from a European Phase III acute clinical trial in 2015. If
approved, the INTERCEPT Blood System for RBCs will be the only system
commercially available in Europe to enhance the safety of red blood cell
transfusions through pathogen inactivation. In addition to plans to
submit for CE Mark registration in Europe, Cerus is also currently in
dialogue with the U.S. Food & Drug Administration regarding a protocol
design for a Phase III pivotal red blood cell study to be conducted in
the continental United States.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood transfusion safety. The INTERCEPT Blood System is designed to
reduce the risk of transfusion-transmitted infections 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 of the INTERCEPT treatment is designed to inactivate established
transfusion threats, such as Hepatitis B and C, HIV, West Nile Virus and
bacteria, as well as emerging pathogens such as chikungunya, malaria and
dengue. 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 www.cerus.com
for information about Cerus.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.
Except for the historical statements contained herein, this press
release contains forward-looking statements concerning Cerus’ products,
prospects and expected results, including statements concerning Cerus’
plans to pursue CE Mark approval in Europe for the red blood cell system
and the timing thereof; the potential for CE Mark approval for and
commercial launch of Cerus’ red blood cell product in Europe; and Cerus’
plans to present data regarding the study results from its study in
transfusion-dependent thalassemia major patients. Actual results could
differ materially from these forward-looking statements as a result of
certain factors, including, without limitation: risks associated with
the uncertain and time-consuming regulatory process, including
completion of all of the CMC activities necessary to support a
regulatory submission; that Cerus may be unable to file for CE Mark
approval of the red blood cell system in Europe in the anticipated
timeframe or at all, and even if filed, that Cerus may be unable to
obtain CE Mark approval, or any other regulatory approvals, of the red
blood cell system in a timely manner or at all; Cerus’ belief
that the results from its clinical trial will support its CE Mark
submission, Cerus’ development of the INTERCEPT Blood System for red
blood cells and its therapeutic potential, the risks associated with the
uncertainty of clinical trial results, as well as other risks detailed
in Cerus’ filings with the Securities and Exchange Commission, including
in Cerus‘ Quarterly Report on Form 10-Q for the quarter ended September
30, 2016, filed with the SEC on November 4, 2016. Cerus disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release.
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Source: Cerus Corporation