Surveillance study to enroll ~3,000 hematology/oncology patients
concurrent with U.S. hospital adoption of INTERCEPT treated products
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS), a biomedical products company focused
on improving blood transfusion safety, today announced that Smilow
Cancer Hospital at Yale-New Haven has enrolled the first patient in the Phase
IV INTERCEPT Platelets Entering Routine Use
(PIPER) study, a prospective, open-label, non-inferiority,
post-marketing surveillance study. The PIPER study is expected to enroll
approximately 3,000 patients at a targeted 15 - 20 U.S. hospitals.
“Smilow Cancer Hospital at Yale New-Haven, as a leading U.S. cancer
hospital, is dedicated to providing our patients with the best care
available,” said Edward Snyder, MD, Professor of Laboratory Medicine and
Director of Transfusion/Apheresis/Tissue Implantation Services. “We
recognize the risks faced by these immunosuppressed patients and believe
that our participation in the PIPER study will allow us to learn more
about platelet transfusions and pulmonary events in this seriously ill
patient population, as well as to provide the highest level of
transfusion safety.”
Yale Cancer Center is one of 45 National Cancer Institute designated
comprehensive cancer centers in the U.S., and is Connecticut’s largest
cancer care provider, participating in over 150 cancer-focused clinical
trials. The Yale team is led by Eric Gehrie, MD and Jeanne Hendrickson,
MD in addition to Dr. Snyder. “The Yale team looks forward to our
collaboration with Cerus on this Phase IV study,” commented Dr. Snyder.
The PIPER study will monitor the transfusion of conventional and
INTERCEPT-treated platelets in hematology/oncology patients, including
those undergoing hematopoietic stem cell transplant, who are expected to
require one or more platelet component transfusions. PIPER will evaluate
the incidence of severe pulmonary adverse events requiring assisted
mechanical ventilation, a clinical concern in transfusion medicine as it
relates to repeated platelet transfusions in patient populations at risk
for lung injury.
“We appreciate Smilow Cancer Hospital’s leadership in this study,” said
Dr. Laurence Corash, Cerus’ Chief Scientific Officer. “PIPER's unique
design will allow Cerus to expand our large portfolio of safety data for
routine use of INTERCEPT-treated platelets.”
“There has been a strong level of interest in participation in PIPER
across leading U.S. cancer hospitals. Physicians recognize the continued
infectious risks associated with platelet transfusions, as well as the
opportunity to reduce these risks afforded by pathogen reduced
platelets,” said William 'Obi' Greenman, Cerus’ President and Chief
Executive Officer. “Patient safety is of utmost importance for
hematology/oncology patients enrolling in PIPER.”
The INTERCEPT Blood System for platelets and plasma has been used in
European blood centers for over a decade. The INTERCEPT Blood System
received FDA approval in December 2014. The INTERCEPT Blood System
leverages the understanding that platelets and plasma do not require
functional DNA or RNA, as opposed to pathogens and donor white blood
cells. Pathogen reduction with the INTERCEPT Blood System is designed to
block the replication process so that harmful viruses, bacteria, and
parasites can no longer replicate and cause disease.
ABOUT THE PIPER STUDY
PIPER is a prospective, open-label surveillance study designed to
evaluate the transfusion of conventional and INTERCEPT-treated platelets
in hematology/oncology patients, including those undergoing
hematopoietic stem cell transplant, who are expected to require one or
more platelet component transfusions. INTERCEPT-treated platelets will
not require gamma irradiation or bacterial detection. PIPER will
evaluate the frequency of assisted mechanical ventilation required to
treat severe pulmonary complications, a common clinical concern in
transfusion medicine as it relates to repeated platelet transfusions in
patient populations at risk for pulmonary complications, such as
hematology/oncology patients. The primary endpoint will be assessed by
and independent pulmonary expert adjudication panel.
The PIPER Phase IV study is currently open and recruiting hospital
participants. For more information, please visit http://intercept-usa.com/study-opportunities/piper-phase-4-study
or www.clinicaltrials.gov.
To become a study site or for more information about participating,
please contact Cerus Corporation via e-mail at piper@cerus.com.
ABOUT THE INTERCEPT BLOOD SYSTEM FOR PLATELETS
The INTERCEPT Blood System for platelets is designed for the ex vivo
preparation and storage of whole blood-derived and apheresis platelets.
The device uses amotosalen HCl (a photoactive compound) and
long-wavelength ultraviolet (UVA) illumination to photochemically treat
platelet components. It has been approved in the U.S. since 2014 and in
Europe since 2002, and is currently used in over 100 blood centers in 20
countries.
The safety and efficacy of INTERCEPT-processed platelets has been
evaluated in 10 controlled clinical studies, with over 800 study
subjects. Routine use of INTERCEPT-processed platelets has been
monitored in over 4,000 patients in active hemovigilance studies
conducted by Cerus in Europe, and additionally through national
hemovigilance reporting systems in France (since 2009) and Switzerland
(since 2010). 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 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 the INTERCEPT Blood System are trademarks of Cerus
Corporation.
Smilow Cancer Hospital at Yale-New Haven is part of the
nationally recognized Yale-New Haven Hospital, and is affiliated with
Yale Cancer Center (YCC), one of only 45 National Cancer Institute
(NCI)-designated comprehensive cancer centers in the nation and the only
such center in Connecticut. Smilow Cancer Hospital, the most
comprehensive cancer facility in New England, is a 14-story,
500,000-square-foot cancer hospital, which includes 168 private
inpatient rooms, multidisciplinary outpatient treatment centers, 12
operating rooms, infusion suites, diagnostic imaging services, and
specialized women's and children’s services. YCC and Smilow Cancer
Hospital are members of the National Comprehensive Cancer Network
(NCCN), an alliance of 25 cancer centers in the U.S., whose mission is
to improve the quality, effectiveness and efficiency of oncology care so
that patients can live better lives. www.ynhh.org/smilow.
Except for the historical statements contained herein, this press
release contains forward-looking statements concerning Cerus’
expectations regarding patient and site enrollment in its Phase IV
post-marketing surveillance study. Actual results could differ
materially from these forward-looking statements as a result of certain
factors, including, without limitation: risks associated with the
commercialization and market acceptance of, and customer demand for, the
INTERCEPT Blood System; 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 related to
Cerus‘ ability to expand the label claims and product configurations for
the INTERCEPT platelet systems in the United States, which will require
additional regulatory approvals; 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,
2015, filed with the SEC on November 6, 2015. Cerus disclaims any
obligation or undertaking to update or revise any forward-looking
statements contained in this press release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151208005349/en/
Source: Cerus Corporation