Aphios Awarded NIH ARRA Challenge Grant for Pathogen Inactivation Technology for Blood Products
September 30, 2009
Woburn, MA — Aphios Corporation today announced that it has been awarded a RC-1 Challenge grant (No. 1RC1HL102822-01) from the National Heart, Lung, and Blood Institute (NHLBI), National Institute of Health's (NIH) American Recovery and Reinvestment Act (ARRA) funds to develop a generally applicable pathogen inactivation technology for blood products.

The recent outbreaks of pandemic strains of the influenza virus such as the H1N1 swine flu, the worldwide AIDS epidemic and the periodic emergence of Ebola and SARS have highlighted a persistent concern in the health care community -- the need for effective pathogen inactivation and removal techniques for human blood plasma and plasma-derived products. There are also a number of emerging viruses such as West Nile and the H5N1 bird flu, and a number of potential bioterrorism pathogens such as B. anthracis, Yersinia pestis (plague), Brucella and smallpox that are of concern to the safety of the human plasma supply chain. In addition to viruses and bacteria, parasites such as Babesia spp. and Plasmodium spp. are major threats of spreading diseases through transfusion.

The causes of the more rapid emergence and spread of these "killer" viruses and pathogens are not entirely known, but are thought to be caused by some combination of deforestation with urbanization of wild virus habitats, evolutionary mutations and rapid global travel. Annually, an estimated 3.8 million Americans are transfused with 28.2 million blood components derived from 12.8 million units of blood donated by apparently healthy volunteers. A rigorous scrutiny of blood donors and the screening of donated blood for various serological markers have significantly reduced the mortality and morbidity due to transfusion-associated infectious agents. Some enzyme immunoassays used for routine screening may detect viral antigens or antibodies, but not the infectious agents themselves. Thus, there could be an asymptomatic window period of infectivity responsible for a residual risk of post-transfusion infection. Current approaches such as pasteurization, solvent-detergent (SD), UV irradiation, and chemical and photochemical inactivation are not always effective against a wide spectrum of pathogens, are sometimes encumbered by process-specific deficiencies, and often result in denaturation of the biologics that they are designed to protect.

Aphios' CFI (critical fluid inactivation) technology is purely physical, inactivates both enveloped and non-enveloped viruses as well as bacterial pathogens, and does not involve the use of heat, chemicals or irradiation that could damage sensitive enzymes and proteins. A generally applicable physical technology for inactivating viruses and emerging pathogens with high retention of biological activity will help ensure a blood supply that is safe from emerging and unknown pathogens as well as bioterrorism threats. Aphios will collaborate with the Armed Forces Institute of Pathology (AFIP), DOD to evaluate the use of CFI to inactivate potential viral and bacterial bioterrorism agents. According to Dr. Arthur D. Lander, University of California, Irvine, a co-inventor of the Aphios CFI technology: "In addition to its direct applicability to human plasma and plasma proteins, CFI has the capability to clear viruses and pathogens from biotechnology drugs and monoclonal antibodies. It also has the potential for the rapid manufacturing of antiviral human and animal vaccines since protein integrity and antigenicity are retained during the purely physical virus inactivation step."
The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of NHLBI, NIH, AFIP and DOD.