Aphios
Awarded SBIR Grant from NIGMS, NIH for Development of a Natural
Virus-Free Fibrin Sealant
November
28, 2000
— Aphios Corporation
has been awarded a SBIR grant from the National Institute
of General Medical Sciences (NIGMS), National Institutes
of Health (NIH) for developing a natural virus-free fibrin
sealant.
Aphios
will develop an improved and natural virus-free fibrin sealant
for off-the-shelf surgical applications and burn treatment
by utilizing its patented virus inactivation technology
platform. The Aphios virus inactivation system is based
on advanced supercritical fluids and near-critical fluids
with/without the use of polar cosolvents (SuperFluids™
) for the gentle and rapid inactivation of both non-enveloped
and enveloped viruses. In this research, Aphios is collaborating
with the American Red Cross’ Holland Laboratory, Rockville,
MD on the in vivo assessment of the hemostatic efficacy
of the developed fibrin sealant. The American Red Cross
is an established world leader in the development of in
vivo models for the evaluation of fibrin sealants.
Current
applications for natural fibrin sealants include repair
and closure of burn, traumatic and chronic wounds and in
ophthalmic, plastic and critical surgical operations. Inactivation
of pathogenic viruses is, however, a major concern. The
constituents of fibrin sealant are from concentrated plasma
proteins derived by fractionation of pooled plasma from
at least 1,000 donors. As such, these compounds have an
increased risk for the transmission of viral disease. Most
commercial products are treated by heat and/or solvents
for virus inactivation, which significantly affect protein
integrity and activity and do not always, inactivate non-enveloped
viruses. Viruses of concern include the enveloped HIV,
the non-enveloped hepatitis A virus and unknowns which are
being created from evolutionary mutations in hospital rooms
or which may have jumped species from animal hosts into
human beings as a result of rain forest disruptions. Pathogenic
viruses increase the risk of chronic and fatal infections
in patients whose very well being are often dependent on
the intravenous biologic and biotechnology products being
administered.
Unlike
certain commercially-available virus inactivation techniques
which only inactivate enveloped viruses and may not be able
to inactivate certain “hot zone” viruses, Aphios’
SuperFluids™ CFI (critical fluid inactivation)
process is generally applicable to all classes of viruses.
Unlike currently-available virus inactivation techniques
that utilize organic solvents, heat and/or chemicals, the
CFI process is purely physical. The CFI process
can reduce the viral load of most enveloped and non-enveloped
viruses by more than 6 logs (99.9999 %) in times less than
20 seconds. Interestingly, the process is very gentle to
therapeutic proteins and enzymes which retain structural
and biological integrity. Products are left without traces
of denaturing solvents or potentially mutagenic chemicals
being utilized in current virus inactivation technologies.
CFI is amenable to batch or continuous-flow operations,
is readily scalable and enjoys economies of scale.
Aphios’ SuperFluids™
CFI process can also be applied to immunoglobulins,
human plasma used for blood transfusions, bone graft materials
and other implantables, heat-labile and sensitive medical
instrumentation, xenotransplantation products, animal sera
used in the biotechnology industry, and recombinant therapeutics
from mammalian cell culture and transgenic animals where
a virus inactivation step is essential and necessary for
the manufacture of safe products. The Company is utilizing
CFI to develop therapeutic/preventative vaccines
for HIV.
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