CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ:CERS) announced today that it has submitted a clinical protocol to the U.S. Food and Drug Administration (FDA) 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. The Treatment Use provision allows the FDA to grant early access to a medical treatment not yet approved in the US when no satisfactory alternative is available to treat patients with serious or life-threatening conditions. The protocol submitted by Cerus is designed to allow blood banks and hospitals in geographies threatened by transfusion-transmitted Chikungunya and dengue the earliest possible access to the INTERCEPT treatment of platelet components. The INTERCEPT platelet system license application is under FDA review, with an approval decision expected in 2015. The INTERCEPT system has been approved for use in Europe for 12 years and is used in over 100 blood centers outside the US.
“We believe the protocol we've submitted will support FDA's goal of making new methods available as quickly as possible to help address the threat of Chikungunya and dengue entering the blood supply,” said Laurence Corash, Cerus' chief medical officer. “Supplies of platelet components are particularly vulnerable during infectious disease epidemics, since the limited 5-day shelf life of this blood component leaves little available time to implement post-donation donor follow-up and complicates the logistics of supplying platelets from other geographical areas.”
In Puerto Rico, there have been approximately 1,000 confirmed cases of Chikungunya infection. The local Department of Health recently issued an administrative order requiring that all blood donations be quarantined for 72 hours pending follow-up on donor history for acute infectious symptoms. Failure to obtain follow-up or a history of symptoms requires the destruction of the donated blood components because there is no approved test available to detect Chikungunya or dengue.
Dengue virus is endemic to the Caribbean region, and 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 mosquitos common in tropical climates as well as significant regions within the continental US, where hundreds of imported infections have already been reported. 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 FDA review of our protocol can take up to 30 days, and if approved, we hope to initiate our first study sites before year end,” said Carol Moore, Cerus' senior vice president of regulatory affairs, quality and clinical. “Review of our PMA submission will continue in parallel with the Treatment Use IDE study.”
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 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 the timing thereof; the ability of INTERCEPT to effectively address the the threat of Chikungunya and dengue entering the blood supply; the review timing of the Company’s IDE submission and the success thereof; and the timing of first use of INTERCEPT under the IDE if approved . 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; that the Company may otherwise encounter unanticipated difficulties complying with the regulatory requirements related to the INTERCEPT Blood System for platelets; that the Company’s PMA or IDE submission 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 comply with the 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.