CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) today announced that the U.S. Food and Drug Administration (FDA) has approved the INTERCEPT Blood System for plasma. The INTERCEPT plasma system is approved for ex vivo preparation of plasma in order to reduce the risk of transfusion-transmitted infection (TTI) when treating patients requiring therapeutic plasma transfusion.
The INTERCEPT Blood System inactivates a broad spectrum of enveloped viruses, non-enveloped viruses, Gram-positive and Gram-negative bacteria, spirochetes and parasites.
While current screening tests for a limited number of pathogens have lowered the risks from transfusion-transmitted infections, these tests are reactive approaches, requiring identification of specific pathogens for which tests can then be developed and implemented. In contrast, pathogen reduction by inactivation is a proactive safety measure-- the process can inactivate susceptible viruses, bacteria, and parasites present in plasma components independently of whether they have been identified as specific blood supply risks. This is critical because there is typically a lag between the emergence of new pathogens, and the recognition that an additional safety intervention may be needed.
"We believe this approval to be a pivotal step toward giving U.S. blood centers a proactive approach for protecting the plasma supply," said William ‘Obi' Greenman, Cerus’ president and chief executive officer. "Cerus’ 22 year commitment to improving transfusion safety has been essential to achieving the U.S. approval for INTERCEPT plasma, and our continued work with FDA on reaching an approval decision for the INTERCEPT Blood System for platelets."
As the recent chikungunya, dengue fever and Ebola outbreaks have demonstrated, pathogens continually emerge and present an ongoing threat to public health. INTERCEPT pathogen reduction has been used in Europe for over 10 years as a safety option for platelet and plasma components, and more recently was made available in the U.S. under two Investigational Device Exemption (IDE) studies. In the first study, INTERCEPT Blood System processed platelets will be used to reduce the risk of transfusion-transmitted dengue and chikungunya viruses, both of which are responsible for current epidemics in the Caribbean region, including Puerto Rico, as well as cases reported in the Southern United States. In the second study, the INTERCEPT plasma system is being used to prepare Ebola convalescent plasma for passive immune transfusion therapy of acutely infected patients, providing an additional layer of safety against pathogens that these recovered donors may have been exposed to due recent travel in Africa. Plasma from recovered Ebola virus patients treated with the INTERCEPT process will be used to create a national stockpile for future patients.
"Plasma transfusions are an essential therapeutic treatment for many patients," said Dr. Susan Stramer, vice president, scientific affairs, Biomedical Services, American Red Cross. "Pathogens for which there are no available screening tests continue to emerge or reemerge in the population due to increases in travel, immigration and climate change, thus potentially increasing risk of transmission to patients and impacting donor availability. Pathogen reduction adds an additional layer of safety for our plasma supply.”
“We are pleased that we can now bring INTERCEPT to the U.S. where the idea for this technology was conceived, “ said Dr. Laurence Corash, chief medical officer and scientific officer of Cerus. “As a physician in San Francisco in the 1980’s we had to face our patients who had contracted HIV from transfusions of blood products. I am grateful to now be able to say to them that there is a proactive process to inactivate similarly virulent pathogens in the blood supply, even if we have not yet identified these newly emergent pathogens.”
Platelets, plasma and red blood cells do not require functional DNA or RNA for therapeutic efficacy. However, pathogens (bacteria, viruses and parasites) and white blood cells do require these nucleic acids in order to replicate. The INTERCEPT Blood System targets this basic biological difference between the therapeutic components of blood, compared to harmful pathogens and donor white blood cells. The system uses a proprietary molecule that when activated, binds to and blocks the replication of DNA and RNA, preventing nucleic acid replication and rendering the pathogen inactive.
Cerus will host a conference call and webcast on Wednesday, December 17 at 8:00 AM ET to discuss the US approval for INTERCEPT plasma. To access the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international).
A replay will be available on the company’s web site, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 54511544. The replay will be available approximately three hours after the call through December 31, 2014.
ABOUT THE INTERCEPT BLOOD SYSTEM FOR PLASMA
The INTERCEPT Blood System for plasma is comprised of single-use plasma processing sets and an ultraviolet (UVA) illumination device for the ex vivo preparation and storage of pathogen-reduced, whole blood-derived or apheresis plasma. The safety and efficacy of plasma prepared with the INTERCEPT Blood System has been evaluated in six clinical studies including a total of over 500 patients. Routine use of INTERCEPT plasma has been monitored in over 50,000 INTERCEPT plasma components transfused to almost 10,000 patients in an active hemovigilance study conducted by Cerus in Europe, and additionally in over 150,000 INTERCEPT plasma components through France's national hemovigilance reporting system in 2009 through 2011. For U.S. product information, see http://www.intercept-usa.com.
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, the INTERCEPT Blood System for plasma has received FDA approval, and the INTERCEPT Blood System for platelets is under regulatory review. The INTERCEPT red blood cell system is in clinical development. See http://www.cerus.com for information about Cerus.
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 commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System for plasma by U.S. blood centers, the ability of INTERCEPT platelets to effectively address the threat of Chikungunya and dengue entering the blood supply, the ability of INTERCEPT to effectively mitigate the risks associated with the use of convalescent plasma to treat patients with Ebola virus disease and the therapeutic benefits to Ebola patients who receive convalescent plasma, and the ability to stockpile treated plasma for future Ebola patients. 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 related to broad market adoption of the INTERCEPT Blood System and budgetary, operational and technical challenges that U.S. blood centers may face in adopting Cerus’ products, Cerus’ limited resources and experience expanding commercialization of its products to new geographies and markets, blood centers’ willingness to comply with the clinical study protocol requirements necessary to use the INTERCEPT Blood System for plasma or platelets for the two IDE studies, unanticipated difficulties that Cerus may encounter in complying with the post-approval regulatory requirements for the INTERCEPT Blood System for plasma, 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 September 30, 2014, filed with the SEC on November 7, 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.