CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that it has submitted
an IDE supplement to the U.S. Food and Drug Administration (FDA) for the
company’s proposed Phase III trial of the INTERCEPT Blood System for red
cells in patients receiving chronic red cell transfusion support for
sickle cell disease (SCD) or thalassemia.
“We look forward to working with FDA to finalize the Phase III study
protocol to support U.S. licensure of INTERCEPT red cells for support of
patients with chronic anemia,” commented Dr. Laurence Corash, Cerus’
chief medical officer. “Chronically transfused patients are at increased
risk both from newly emerging pathogens, such as dengue virus, and from
known infectious agents, such as Babesia, for which there are no
currently licensed tests. Pathogen inactivation of red cells offers a
potential new treatment option for this vulnerable patient population,
who may face lifetime exposure to blood transfusion.”
The proposed trial design includes approximately 400 patients, who would
receive transfusions of INTERCEPT or control red cells for treatment of
sickle cell disease or thalassemia. Proposed endpoints of the study are
designed to assess both the efficacy and safety of INTERCEPT red cells.
FDA has provided guidance that an approximately 60 red cell unit paired
in vitro study and an additional Phase I recovery and survival study
using the final clinical disposable sets and reagents in healthy
subjects will be required prior to initiation of the proposed Phase III
trial. These prerequisite studies may need to be finished and the data
submitted prior to the FDA’s review of the Phase III protocol supplement
filed in the IDE. Previous discussions with the FDA indicated that
Cerus’ Phase III protocol could be reviewed under a Special Protocol
Assessment (SPA), but upon receipt of the application the FDA amended
its position and requested use of the IDE route. The proposed Phase III
study size and endpoints in the IDE supplement are identical to those
previously planned for SPA review.
An approved Investigational Device Exemption (IDE) is required to allow
use of an investigational device in a clinical study to collect safety
and efficacy data to support a Premarket Approval (PMA) application.
More information about the IDE process is available from the FDA
website: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/default.htm
ABOUT CERUS
Cerus Corporation is a biomedical products company focused on
commercializing the INTERCEPT Blood System to enhance blood safety. The
INTERCEPT system is designed to reduce the risk of
transfusion-transmitted diseases 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 enables
INTERCEPT treatment to inactivate established transfusion threats, such
as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed
to inactivate emerging pathogens such as influenza, malaria and dengue.
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. The INTERCEPT red blood cell system is in clinical development.
See http://www.cerus.com
for more information.
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 the proposed Phase
III INTERCEPT red cell system trial, the therapeutic and commercial
potential of the INTERCEPT red cell system, and future regulatory
matters, including those related to the IDE process with the FDA, the
number and scope of additional studies required prior to initiating the
proposed Phase III INTERCEPT red cell system trial, and potential
regulatory approval. 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 associated with the
uncertain clinical development and regulatory approval process,
including the risks that Cerus’ IDE application may not be reviewed or
approved by the FDA in a timely manner or at all, that the FDA may
require that we conduct additional unanticipated clinical studies to
initiate Phase III development of the INTERCEPT red cell system and/or
to support potential approval of INTERCEPT red cells, and that we may
never obtain FDA approval of INTERCEPT red cells, risks associated with
Cerus’ need for additional capital, including the risk that Cerus may be
unable to raise the funds necessary to conduct the proposed Phase III
INTERCEPT red cell system trial or any other trials of the INTERCEPT red
cell system required by the FDA, and other risks detailed in the Cerus'
filings with, the Securities and Exchange Commission (SEC), including in
Cerus' annual report on Form 10-K for the year ended December 31, 2011,
filed with the SEC on March 5, 2011. 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.
Source: Cerus Corporation