CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that the U.S. Food and Drug Administration (FDA) has accepted Cerus’ clinical protocol to make the INTERCEPT Blood System for platelets available under an Expanded Access Investigational Device Exemption (IDE) to regions in the United States with outbreaks of Chikungunya and dengue virus.
Dengue virus is endemic to the Caribbean region. Local transmission of Chikungunya virus was detected in the Caribbean for the first time in February of 2014. Both viruses are spread by species of mosquitoes common in tropical climates as well as regions within the continental U.S. Chikungunya virus causes high fevers, joint pain and swelling, headaches and a rash. Symptoms have been reported to persist for up to 2 years in chronic cases. Rarely, Chikungunya can be fatal.1 Symptoms of dengue include high fever, headaches, joint and muscle pain, vomiting, and a rash. In some cases, dengue infection is life threatening due to dengue hemorrhagic fever, which causes bleeding from the nose, gums, or under the skin. It can result in cause dengue shock syndrome, with massive bleeding.2 As of September 30, 2014, the Centers for Disease Control and Prevention (CDC) has reported 11 confirmed locally transmitted cases of Chikungunya in Florida, 421 cases in Puerto Rico and 45 cases in the U.S. Virgin Islands. Local transmission of dengue has also been reported in Texas and Florida.
“We are pleased to provide U.S. blood centers and hospitals early access to INTERCEPT for the treatment of platelet components in light of the escalating threat of Chikungunya and dengue transfusion-transmitted infections,” said Carol Moore, Cerus' senior vice president of regulatory affairs, quality and clinical. “With this expeditious approval of our IDE, we hope to initiate our first study site before year end.”
Cerus’ clinical protocol was submitted to the FDA in September under the Treatment Use provision. This provision allows for early access to a medical treatment not yet approved in the United States when no satisfactory alternative is available to treat patients with serious or life-threatening conditions. Under the IDE, INTERCEPT treatment can be performed in place of bacterial detection, gamma irradiation, and CMV testing, resulting in simplified logistics and timely release of platelet products. Currently, there are no licensed tests to detect Chikungunya or dengue virus in asymptomatic blood donors. The INTERCEPT blood system provides the potential to reduce the risk of transfusion-transmitted dengue and Chikungunya virus as demonstrated in the French Antilles blood center which has used INTERCEPT technology for 6 years.
The reviews of Cerus’ Premarket Approval (PMA) submissions for INTERCEPT plasma and platelets will continue in parallel with the Treatment Use IDE study. Approval decisions for both PMA submissions are expected in 2015.
ABOUT INTERCEPT BLOOD SYSTEM FOR PLATELETS
The INTERCEPT Blood System for platelets uses a photochemical treatment to crosslink nucleic acid, rendering susceptible pathogens incapable of replicating and causing disease. Published studies have demonstrated INTERCEPT inactivation of >6.4 log of Chikungunya and >5.3 log of dengue infectious titers, both in excess of observed titers in asymptomatic donors. The system was implemented universally during the 2006 Chikungunya outbreak on the island of La Reunion, and during that period there were no documented cases of Chikungunya transmitted through donated platelets. The INTERCEPT platelet system has been approved in Europe since 2002 and is currently used at over 100 blood centers in 20 countries. The platelet system is under regulatory review in the United States, Canada, Brazil and China.
Cerus Corporation is a biomedical products company focused in the field of blood safety. 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. In the United States, Cerus is seeking regulatory approval of the INTERCEPT Blood System for plasma and platelets. 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 potential approval by the FDA of the Company’s PMA submission for the INTERCEPT Blood System for platelets and plasma, and the timing thereof; the ability of INTERCEPT to effectively address the threat of Chikungunya and dengue entering the blood supply; the timing of first use of INTERCEPT under the IDE if approved; and the impact of INTERCEPT on the logistics and timing of release for platelet products. 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 market acceptance of, and customer demand for, the INTERCEPT Blood System; the uncertain and time-consuming regulatory process, including the risks that the Company may be required to complete additional clinical trials in order to obtain approval of its PMA submission for platelets and/or plasma; that the Company may otherwise encounter unanticipated difficulties complying with the regulatory requirements related to the INTERCEPT Blood System for platelets and/or plasma; that the Company’s PMA for platelets might not be approved by the FDA in a timely manner or at all; that the Company may not have the resources to support multiple regulatory submissions; that blood centers are willing to comply with the clinical study protocol requirements necessary to use the INTERCEPT Blood System for platelets under an IDE; and other risks detailed in Cerus' filings with the Securities and Exchange Commission (SEC), including in Cerus' quarterly report on Form 10-Q for the quarter ended June 30, 2014, filed with the SEC on August 8, 2014. 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.