Whittemore Peterson Institute and Cerus Announce Inactivation of XMRV in Platelets and Red Blood Cells by the INTERCEPT Blood System

RENO, Nev. & CONCORD, Calif.--(BUSINESS WIRE)--The Whittemore Peterson Institute for Neuro-Immune Disease (WPI) and Cerus Corporation (NASDAQ:CERS) presented data at today's NIH-sponsored 1st International Workshop on XMRV which demonstrates the efficacy of Cerus' INTERCEPT Blood System to inactivate XMRV and other MLV-related viruses in donated blood. Recent scientific studies have detected these human retroviruses in up to seven percent of healthy blood donor samples, indicating approximately 20 million people in the United States could unknowingly be carrying the infection. XMRV and MLV-related viruses have been linked to prostate cancer and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

“The genetic variability of XMRV and MLV-related viruses will make development of screening assays for the blood supply challenging”

"The genetic variability of XMRV and MLV-related viruses will make development of screening assays for the blood supply challenging," said Dr. Judy Mikovits, director of research at WPI and lead author of the study. "The INTERCEPT technology demonstrates robust inactivation of these viruses and holds promise as a potential proactive approach to mitigating the risk of XMLV/MLV-related virus transmission via transfusion."

Co-author Dr. Lily Lin, vice president of global scientific affairs for Cerus, added, "The INTERCEPT system inactivates pathogens by crosslinking their DNA or RNA, which blocks their ability to replicate and prevents transmission of the infection. This mechanism of action is designed to provide prospective protection against emerging threats like XMRV and its genetic variants."

In a paper published online on August 23, 2010 in the journal Proceedings of the National Academy of Sciences (PNAS), scientists from the National Institutes of Health and U.S. Food and Drug Agency detected the presence of a genetically diverse group of MLV-related viruses in 86 percent of CFS patient samples and in 6.8 percent of samples from healthy blood donors, leading to new concerns about the possibility of transfusion transmission. The PNAS study results are consistent with data from a 2009 study published in Science, which detected XMRV in 67 percent of CFS patients and 3.7 percent of healthy controls.

In the study conducted by WPI and Cerus, red blood cell and platelet components were contaminated with a natural isolate of XMRV and MLV-related viruses from an ME/CFS patient. INTERCEPT-treated and control samples were evaluated in a validated virus culture test, which allows sensitive detection of viral particles that are capable of reproducing. No viable virus was detected following treatment, indicating the INTERCEPT Blood System is capable of inactivating high levels (>4 logs) of the virus.

The INTERCEPT systems for platelets and plasma are used by over 60 blood centers in Europe, Russia and the Middle East. The INTERCEPT red cell system is in clinical development. The INTERCEPT Blood System is not yet approved for use in the United States.

ABOUT THE WHITTEMORE PETERSON INSTITUTE

The Whittemore Peterson Institute for Neuro Immune Disease exists to bring discovery, knowledge, and effective treatments to patients with illnesses that are caused by acquired dysregulation of both the immune system and the nervous system, often resulting in lifelong disease and disability. The Whittemore Peterson Institute is the first institute in the world dedicated to neuro-immune diseases, integrating patient treatment, basic and clinical research and medical education.

ABOUT CERUS

Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action allows INTERCEPT treatment to inactivate both established transfusion threats, such as hepatitis, HIV, West Nile virus and bacteria, as well as emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, Russia, the Middle East and selected countries in other regions around the world. The INTERCEPT red blood cell system is in clinical development. Visit http://www.cerus.com for more information.

INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.

References

1. Lo SC, et al. (2010) Detection of MLV-related virus gene sequences in blood of patients with chronic fatigue syndrome and healthy blood donors. Proceedings of the National Academy of Sciences, published online before print August 23, 2010.
http://www.pnas.org/content/early/2010/08/16/1006901107.full.pdf+html

2. Lombardi VC, et al. (2009) Detection of an infectious retrovirus, XMRV, in blood cells of patients with chronic fatigue syndrome. Science 326:585–589.
http://www.sciencemag.org/cgi/content/abstract/1179052

3. Mikovits J, et al. (2010) Inactivation of XMRV and MLV-related viruses in platelet and RBC components prepared with the INTERCEPT Blood System. Presented at the 1st International Workshop on XMRV, September 7-8, 2010 (Bethesda, MD).
http://www.interceptbloodsystem.com/recent_publications.html

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