Aphios
Awarded NIH ARRA Challenge Grant for Pathogen Inactivation
Technology for Blood Products
September
30, 2009 —
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 (plaque),
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.
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