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 firstname.lastname@example.org.
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.
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.