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| |  Fibrin Sealant Demonstrates Reduced Complications From Breast Cancer Surgery NEW YORK, NY. -- October 15, 1997 -- V.I. Technologies, Inc. announced the results of Phase II clinical trials on its doubly-virally inactivated fibrin sealant. The multi-center, prospective, randomized-control Phase II clinical trial showed Vitex’s fibrin sealant reduced complications resulting from breast cancer surgery. The results were presented today by Dr. Marcia Moore of the University of Virginia, at the American College of Surgeons meeting. Breast cancer surgery is frequently complicated by the accumulation of fluid at the surgery site, which can lead to patient discomfort, wound breakdown, infection and acute swelling. In order to minimize these complications, it is necessary to leave drains in place for up to several weeks, causing patient discomfort. Despite the use of drains, the complication rate of the surgery can be up to 60 percent. The trial demonstrated the use of Vitex’s fibrin sealant reduced the amount of fluid accumulating at the surgical site by approximately 50 percent and decreased the time the drain was in place by more than half. For patients undergoing a lumpectomy operation for breast cancer, the median time to drain removal was 24 days in the control patients versus 10 days in the patients treated with the fibrin sealant. There were no side effects associated with its use. "This represents a major advance in the surgical treatment of breast cancer patients" Dr. Moore explained. "This is the first time that it has been demonstrated that the fluid drainage can be reduced in these patients and it is conceivable now, for the first time, to consider surgery without the placement of drains at all. “This will be a major benefit to patients who, with standard surgical procedures, currently are required to have uncomfortable drains in place for prolonged periods following their surgery." Fibrin sealants are tissue adhesives used during surgical procedures for hemostasis and sealing of tissues. They are created by combining two blood clotting factors, fibrinogen and thrombin, derived from human plasma. These biological glues stop the flow of blood or other fluids that often occurs after closing an incision. Fibrin sealants offer three primary benefits related to wound healing: speed, less scarring, and reduced leakage and blood loss. Vitex has developed a doubly-virally inactivated fibrin sealant. Both the fibrinogen and the thrombin components are treated by two complementary viral inactivation (VI) procedures which eliminate the risk of the transmission of viruses. Each component of the fibrin sealant is treated by the Solvent Detergent (SD) VI method and also by a second proprietary VI procedure, short wavelength ultraviolet light (UVC), which has been shown to eliminate infectious doses of both enveloped and non-enveloped viruses. Phase III trials are currently ongoing in collaboration with United States Surgical Corporation.
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