Cerus Corporation (NASDAQ: CERS) announced results from 10 studies on the INTERCEPT Blood System, presented this week at the AABB annual meeting in Montreal, Canada. Study outcomes highlighted the application of the INTERCEPT Blood System for inactivation of harmful bacteria in the blood supply in place of standard bacterial screening methods and meeting certain international accreditation standards required by the AABB. Studies also highlighted data from the INTERCEPT red blood cell program showing inactivation of a broad range of pathogens while maintaining proper hydration and functionality of red cells treated with INTERCEPT.
Highlights from the INTERCEPT presentations include:
Residual Bacterial Contamination Risks and Mitigations at the Kuwait Central Blood Bank
The Kuwait Central Blood Bank identified drawbacks using advanced bacterial detection methods, and therefore implemented INTERCEPT Blood System for platelets – a proactive pathogen inactivation approach to reducing bacterial contamination. Further, AABB Standard 184.108.40.206. allows AABB accredited blood centers to replace bacterial detection with pathogen inactivation technologies such as the INTERCEPT platelet system.
“The Kuwait Central Blood Bank’s decision to replace traditional bacterial screening approaches and implement INTERCEPT represents a proactive approach to addressing the shortcomings of current blood safety practices,” said Dr. Larry Corash, senior vice president and chief medical officer of Cerus. “To our knowledge, Kuwait is the first blood center to receive international accreditation from the AABB using pathogen inactivation as a substitute for blood screening requirements. This sets a precedent for other blood banks seeking accreditation using pathogen inactivation.”
Response to Transfusion of 6 and 7-Day Old Platelet Components Treated with INTERCEPT Blood System
Researchers evaluated the efficacy and safety of platelets treated with the INTERCEPT Blood System and stored six and seven days. The study concluded that no bacterial contamination was reported in six and seven day platelets treated with INTERCEPT and no episodes of transfusion transmitted sepsis were reported. The safety of INTERCEPT-treated platelets stored for six and seven days was comparable to untreated platelets, which can be stored for a maximum of five days.
“The outcome of this study indicates that INTERCEPT can inactivate bacteria in donated platelets for transfusion to safely extend the shelf life of stored platelets from five days to as long as seven days. Current practice in the USA and several European countries is to store platelets for maximum five days. This shelf life extension can have a profoundly positive impact on the blood supply, providing blood centers with significant operational advantages in managing inventories and easing their collection needs over weekends and holidays,” Dr. Corash noted.
INTERCEPT Pathogen Inactivation for Plasma: Analysis of the Preservation of Coagulation Factors and Ease of Implementation
Researchers evaluated the ability to inactivate a broad range of pathogens and preserve coagulation factors of plasma treated with INTERCEPT for use with routine operations. Following one month of frozen storage, the factor activities were within the therapeutic range. Similar results were also obtained from previously frozen, thawed, INTERCEPT-treated plasma.
Evaluation of RBC Hydration After Treatment with S-303 Pathogen Inactivation at Varying Hematocrits
The study found that storage for up to six weeks of red blood cells treated with the modified INTERCEPT red blood cell system did not significantly alter red blood cell hydration. Researchers concluded that the modified red blood cell system also provides pathogen inactivation over a range of hemotocrit used in common component processing methods for red blood cells. These results demonstrate the flexibility of the system, facilitating integration of the INTERCEPT system into the routine blood center operations.
“We are planning to initiate a Phase I clinical trial with the INTERCEPT red blood cell system later this year,” added Dr. Corash. “We are also pleased to continue the further development of the red cell system in partnership with the German Red Cross, as previously announced. The studies reported at the AABB annual meeting are preliminary confirmation that we have been able to maintain hydration of stored red blood cells, an important consideration for broad application. These studies also demonstrated that the INTERCEPT red blood cell system has the ability to inactivate a broad range of pathogens.”
Cerus also hosted a workshop titled “Use of Pathogen Inactivation Technologies to Meet AABB Standards” on Tuesday, Oct. 7th from 7:00 to 8:15 a.m. The workshop highlighted blood banking experience using INTERCEPT as a replacement for gamma irradiation, CMV Serology and bacterial detection. A summary of the workshop and a link to the Web cast will be made available in the coming weeks.
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. The system inactivates pathogens in platelets and plasma using a 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. More than 200,000 INTERCEPT Blood System disposable kits have been shipped to date to more than 60 sites in 20 countries. No pathogen inactivation system has been shown to inactivate all pathogens. For more information on the INTERCEPT Blood System visit www.interceptbloodsystem.com.
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, the Middle East and other regions around the world. 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 Cerus’ plans to pursue clinical development of INTERCEPT red blood cell system, the timing thereof. Words such as "plan" 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 on Form 10-Q for the quarter ended June 30, 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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