Cerus Presents Results of European Phase 3 Chronic Anemia Study at the 23rd Congress of European Hematology Association

Cerus Corporation (Nasdaq: CERS) announced that results from SPARC, the
Company’s European Phase 3 study evaluating the efficacy and safety of
INTERCEPT-treated red blood cells (RBCs) in thalassemia major patients,
were presented today at the 23rd Congress of European
Hematology Association (EHA) in Stockholm Sweden in a poster
presentation entitled, “A Randomized, Controlled, Phase III Study to
Evaluate S-303/Glutathione Pathogen-Inactivated Red Blood Cells in
Thalassemia Major Patients (SPARC).” Thalassemia major patients require
life-long RBC transfusions to prevent bone marrow expansion and correct
anemia but may impact iron (Fe) balance and the need for chelation
therapy. Hemoglobin (Hb) consumption (grams/kg/day) is an important
measure of clinical efficacy because each gram of Hb carries a burden of
3.5mg of Fe.

“We are pleased to present these data from the SPARC study at EHA, one
of the premier scientific meetings targeted at the European hematology
community,” said Dr. Richard Benjamin, Cerus’ chief medical officer.
“Patients in need of chronic transfusions of red blood cells are at
elevated risk of transfusion transmitted infections (TTI) from existing
and emerging pathogens. We believe the INTERCEPT-treated RBCs have the
potential to reduce the risk of TTI and improve patient care.”

SPARC was a randomized, controlled, double blinded non-inferiority
study. Subjects were randomized to sequential treatment periods of
INTERCEPT-treated RBCs and conventional RBCs with cross over to the
other treatment upon completion of the first treatment period. Each
treatment period consisted of six transfusion episodes over
approximately 5 to 6 months. Patients maintained their targeted
transfusion threshold as medically indicated before and during the study
period. The primary efficacy endpoint was red blood cell Hb consumption
over four transfusion episodes in each treatment period expressed as the
total Hb mass transfused per subject, adjusted for body weight and time.
The pre-determined non-inferiority margin was 15%. The primary safety
endpoint was treatment-emergent antibodies with confirmed specificity to
INTERCEPT-treated RBC. Patients were enrolled at two sites in Italy and
one site in Turkey.

A total of 81 patients with a mean age of 26.1 ± 8.1 years (range 10-44)
were transfused. On an intent-to-treat basis, total mean Hb consumption
in the evaluation period was 0.113 ± 0.04 g/kg/day in the INTERCPT arm
compared to 0.111 ± 0.04 g/kg/day in the control arm. The primary
efficacy endpoint was achieved, with a mean treatment difference of
0.002 g/kg/day (1.8%), well below the pre-determined 15% inferiority
margin (<0.017g/kg/day). The primary safety endpoint also was achieved
with no treatment emergent antibodies with confirmed specificity to
INTERCEPT-treated RBCs or RBC antigens. Adverse events were balanced
between Test and Control periods. There were no deaths, grade 4
(life-threatening or disabling) adverse events, or events deemed certain
or likely related to INTERCEPT-treated RBCs.


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 http://www.cerus.com
for information about Cerus.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus

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