mardi 7 juillet 2020


Cerus Reports Positive Top-Line Results from Chronic Anemia Phase 3 Study Evaluating INTERCEPT Red Blood Cells in Thalassemia Patients

Par Rédaction , dans Communiqués , le 23 janvier 2018

Tuesday, January 23rd 2018 at 9:15pm UTC
  • Study successfully met primary efficacy and safety endpoints
  • No antibodies detected specific to INTERCEPT treated red blood cells
  • No treatment-emergent antibodies to red blood cell alloantigens
  • Conference call scheduled tomorrow at 8:30 am ET, Wednesday January
    24

CONCORD, Calif.–(BUSINESS WIRE)– Cerus Corporation (NASDAQ: CERS) today reported that the primary
efficacy and safety endpoints were successfully achieved in the
company’s Phase 3 transfusion study of chronic anemia evaluating
INTERCEPT-treated red blood cells (RBCs) in thalassemia patients, SPARC
(A Randomized Controlled Study to Evaluate Efficacy and Safety of S-303
Treated Red Blood Cells in Subjects with Thalassemia Major Requiring
Chronic RBC Transfusion). The results from the SPARC study provide
important clinical data regarding the safety profile of
INTERCEPT-treated RBCs in a chronically transfused patient population
and support Cerus’ INTERCEPT RBC CE mark submission, which is planned
for the second half of 2018.

The study’s primary efficacy endpoint used a non-inferiority design to
assess up to a 15% relative difference in the mean consumption of
hemoglobin between INTERCEPT-treated RBC and conventional RBC. The
safety endpoints included the incidence of treatment-emergent antibody
with confirmed specificity to INTERCEPT-treated RBCs, the incidence of
antibodies to red blood cell alloantigens, the incidence of adverse
events, and the incidence of transfusion reactions.

A total of 86 patients were enrolled at three participating
international sites in the double blinded, cross-over study. Subjects
were randomly assigned to a sequential treatment period of either
INTERCEPT-treated RBCs or conventional RBCs with cross over to the other
treatment upon completion of the first treatment period. Each treatment
period consisted of 6 transfusion episodes. A total of 2006 units were
transfused during the course of the study, with 999 in the Control arm
and 1007 in the Test arm. Full results of the study are planned for
submission and presentation at upcoming scientific conferences and for
publication.

“These study results mark a major milestone in our mission to make
INTERCEPT the standard of care in transfusion medicine. Thalassemia
major patients require a lifetime of red cell transfusion, putting these
individuals at elevated risk of transfusion transmitted infections (TTI)
from existing and emerging pathogens. We believe that the INTERCEPT
Blood System has the potential to markedly reduce the risk of TTI for
patients needing red cell transfusions,” said Richard Benjamin, Cerus’
chief medical officer.

In addition to the SPARC study in thalassemia patients, the company’s
planned 2018 CE mark submission also will include previously reported
clinical results from the company’s successful European Phase 3 study in
patients with acute anemia. In the U.S., the company is conducting a
Phase 3 study of INTERCEPT-treated RBCs (RedeS) in Puerto Rico and the
mainland to ameliorate the risk of Zika virus, and is preparing to
initiate a separate Phase 3 study of INTERCEPT-treated RBCs with 600
patients undergoing complex cardiovascular surgery (ReCePI) to support a
potential Premarket Approval application (PMA) submission to the FDA for
the INTERCEPT Blood System for RBCs.

CONFERENCE CALL INFORMATION

Cerus will host a conference call and webcast tomorrow, January 24 at
8:30 AM ET to discuss the top-line results from SPARC, a Phase 3 study
evaluating the safety and efficacy of INTERCEPT treated red blood cells
in thalassemia patients.

To access the live webcast, please visit the Investor Relations page of
the company’s 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 website, or by dialing (855)
859-2056 (U.S.) or (404) 537-3406 (international) and entering
conference ID number 4961559. The replay will be available approximately
three hours after the call through February 7, 2018.

ABOUT THALASSEMIA

Thalassemia is a genetic blood disorder caused by a defect in synthesis
of hemoglobin, the oxygen-carrying component of the red blood cell.
Insufficient production of hemoglobin results in severe chronic anemia
leading to multiple organ dysfunction unless treated with transfusion
support. Thalassemia major is the most severe form of the disease and
symptoms may present in patients as early as 6-months old. Patients with
thalassemia major may require a lifetime of transfusions. Thalassemia is
more common in individuals from Mediterranean countries, Asia, Africa,
and the Middle East.

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

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.

Forward-Looking Statements

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 concerning Cerus‘ planned
INTERCEPT red blood cell CE Mark submission and the timing thereof;
Cerus’ mission to make INTERCEPT the standard of care in transfusion
medicine; Cerus’ belief that the INTERCEPT Blood System has the
potential to markedly reduce the risk of TTI; Cerus’ planned Phase 3
ReCePI study; the potential submission of a PMA to the FDA by Cerus for
the INTERCEPT Blood System for RBCs; and other statements that are not
historical facts. Actual results could differ materially from these
forward-looking statements as a result of certain factors, including,
without limitation: risks related to Cerus’ ability to demonstrate to
the transfusion medicine community and other health care constituencies
that pathogen reduction and the INTERCEPT Blood System is safe,
effective and economical; the uncertain and time-consuming development
and regulatory process, including the risks (a) that Cerus may be unable
to file for CE Mark approval of the red blood cell system in Europe on
the anticipated timeframe or at all, and even if filed, 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, (b) that
applicable regulatory authorities may disagree with Cerus‘
interpretations of the data from its clinical studies and/or may
otherwise determine not to approve Cerus‘ regualtory submissions in a
timely manner or at all; (c) that anticipated clinical trials of the
INTERCEPT Blood System may not be initiated on the ancticipated timing
or at all, or if initiated, may be extended, delayed, suspended or
terminated, including as result of safety concerns, and (d) that
negative or inconclusive results in Cerus‘ Phase 3 studies of INTERCEPT
RBCs, including in the RedeS or the ReCePI studies would negatively
impact, substantially delay or preclude altogether, Cerus‘ ability to
submit a PMA to the FDA for INTERCEPT Blood System for RBCs and Cerus‘
ability to obtain regulatory approval of the INTERCEPT Blood System for
RBCs in the United States, and that Cerus may otherwise be unable to
submit a PMA to the FDA for the INTERCEPT Blood System for RBCs in a
timely manner or at all; risks related to Cerus‘ need for additional
funding; risks future opportunities and plans, as well as other risks
detailed in Cerus’ filings with the Securities and Exchange Commission,
including Cerus’ Quarterly Report on Form 10-Q for the quarter
ended September 30, 2017, filed with the SEC on November 3, 2017.

Cerus disclaims any obligation or undertaking to update or revise any
forward-looking statements contained in this press release.

Contacts

Cerus Corporation
Tim Lee, 925-288-6137
Investor Relations
Director
or
Media Contact:
W20 Communications
Dan
Boyle
dan@boylepr.com

Source: Cerus Corporation

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