Aphios Awarded SBIR Grant from NIGMS, NIH for Development of a Natural Virus-Free Fibrin Sealant
November 28, 2000

Woburn, MA — 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 or without the use of polar cosolvents (SuperFluids™) for the gentle and rapid inactivation of both nonenveloped 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 nonenveloped viruses. Viruses of concern include the enveloped HIV, the nonenveloped 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 rainforest 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 nonenveloped 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 for the manufacture of safe products. The Company is utilizing CFI to develop therapeutic/preventative vaccines for HIV.