Cerus Corporation (NASDAQ:CERS) announced today results from 32 studies on the INTERCEPT Blood System presented at the International Congress of the International Society of Blood Transfusion in Macao SAR, China. Study outcomes highlight clinical experience implementing the INTERCEPT Blood System for platelets and plasma into routine practice. Others demonstrate INTERCEPT’s utility in the inactivation of current and emerging pathogens, such as malaria and avian influenza, in donated blood. The safety and efficacy of the INTERCEPT Blood System are also highlighted in results from a multi-year hemovigilence surveillance program and in a study of patients with a severe congenital bleeding disorder undergoing major surgery.
“The clinical outcomes from these studies further support the broad application of the INTERCEPT Blood System to increase blood safety and improve results for patients who require blood transfusions,” said Laurence Corash, M.D., senior vice president and chief medical officer at Cerus Corporation. “More than 150,000 INTERCEPT Blood System disposable kits have been shipped to date to more than 60 sites in 20 countries, with mounting evidence for continued broader adoption of our pathogen inactivation technology.”
Highlights from the INTERCEPT presentations include:
Photochemical Inactivation with Amotosalen and UVA Light of Protozoan Parasites in Platelet and Plasma Components Using INTERCEPT Blood System evaluated the efficacy of the INTERCEPT platelet and plasma systems for inactivation of malaria, T. cruzi (agent of Chagas’ disease), leishmania and babesia, which are not routinely screened for at time of blood donation. Results from the study showed significant reduction of protozoan parasite levels, demonstrating INTERCEPT’s potential to reduce the risk of transfusion-transmitted parasitic infections from platelets and plasma.
“These study results indicate the ability of INTERCEPT to prevent transmission through blood transfusions of infectious, blood-borne diseases caused by emerging pathogens in areas where blood testing and screening procedures are not currently implemented,” added Dr. Corash. “INTERCEPT was profoundly successful in safeguarding the platelet supply in La Réunion, France during a Chikungunya virus outbreak in 2006, and could have similar utility in safeguarding the blood supply in regions threatened by other infectious diseases such as malaria and dengue.”
Inactivation of Influenza Virus Type A H5N1 in Platelets and Plasma by Treatment with the INTERCEPT Blood System evaluated the efficacy of the INTERCEPT platelet and plasma systems to inactivate avian flu virus, a pathogen not currently tested for in the donor blood screening process. The study found that no viable avian flu virus was detected in either platelets or plasma following treatment with the INTERCEPT Blood System, demonstrating complete inactivation of the virus within the detection limits of the assay.
“The impact of this study outcome means that pathogen inactivation offers the potential to maintain an adequate and safe blood supply in the event of an avian flu pandemic,” Dr. Corash noted.
Clinical Experience with Conventional Versus INTERCEPT Platelet Concentrates Transfused to All Patients During Two One-Year Periods: Reduction of Adverse Events with Equivalent Use of Blood Products detailed data on the routine use of the INTERCEPT platelet system, comparing patient responses to INTERCEPT-treated platelets in additive solution versus conventional (untreated) platelets suspended in 100 percent plasma. Results from over 10,000 conventional platelet transfusions and 13,000 INTERCEPT-treated platelet transfusions to a broad patient population for a spectrum of indications showed that the pathogen inactivation system was well tolerated in routine practice. Using INTERCEPT allowed blood centers to avoid implementing bacterial detection methods, using gamma irradiation and testing CMV serology. Incidence of adverse events was less with INTERCEPT treated platelets than with untreated platelets, indicating that INTERCEPT may improve safety and availability of platelet transfusions.
Intensive and Successful Transfusion of Pathogen Inactivated INTERCEPT Platelet Concentrates for Major Gynecological and Obstetrical Surgery in Glanzmann Thrombasthenia Type 1 with Gypsy Mutation documented the ability of INTERCEPT-treated platelets to support two patients with a recessive autosomal severe bleeding disorder during surgical procedures. This is the first demonstration that patients with a congenital bleeding disorder can be safely managed through surgical procedures with platelets treated with pathogen inactivation technology.
Implementation of Pathogen Inactivated Therapeutic Apheresis Plasma Following Photochemical Treatment with INTERCEPT by EFS-Alsace, a French Regional Blood Center evaluated the routine use of INTERCEPT treated plasma for transfusion in place of quarantined plasma. The study concluded that the INTERCEPT plasma system can be used to replace quarantined plasma to meet the needs of a regional blood center.
The INTERCEPT Blood System
The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens, such as viruses, bacteria and parasites, as well as harmful white blood cells that may be present in donated blood intended for transfusion. No pathogen inactivation system has been shown to inactivate all pathogens. The system inactivates pathogens in platelets and plasma using the same proprietary illumination device, process and active compound. The INTERCEPT Blood System is designed to be easily incorporated into the typical operations of blood banks and to provide protection against a broad spectrum of known and emerging pathogens. The INTERCEPT Blood System has received CE mark approvals for both the platelet and plasma systems.
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT Blood System is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. Cerus currently markets the INTERCEPT Blood System for both platelets and plasma in Europe and the Middle East. The company is also pursuing regulatory approvals in the United States and other countries. The INTERCEPT red blood cell system is currently in clinical development.
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 commercial acceptance, breadth of application, effectiveness and efficacy of the INTERCEPT Blood System and its ability to maintain a safe blood supply. Words such as "potential," "could have," "can be" and similar words or expressions or the negative of these words or expressions are intended to identify forward-looking statements. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the timing and success of clinical trials, the commercialization of the INTERCEPT Blood System, and market acceptance of the INTERCEPT Blood System, as well as other risks detailed in the company's filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2007, and the quarterly report of Form 10-Q for the quarter ended March 31, 2008. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company does not undertake any obligation to update any forward-looking statements as a result of new information, future events, changed assumptions or otherwise.
William J. Dawson, Vice President, Finance & CFO
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