CONCORD, Calif., July 8 /PRNewswire/ -- Cerus Corporation (Nasdaq: CERS) today announced that results of a Phase 2b study demonstrate compatibility between its proprietary pathogen inactivation system for platelets and gamma irradiation, a process which is commonly used to prevent post-transfusion complications due to contaminating leukocytes (white blood cells). The study involved 14 healthy subjects who were transfused with platelets treated with Cerus' pathogen inactivation system and gamma irradiation. The subjects had previously participated in the Phase 2a study, in which they were transfused with platelets treated with the pathogen inactivation system, but without gamma irradiation. The mean platelet recovery and life span data in Phase 2b were consistent with those of the 2a study, and fell within the range of published studies for currently approved platelet concentrates. The clinical investigators reported no adverse events attributable to transfusion with the treated platelets.
"We chose to study our system in combination with gamma irradiation to give us more flexibility when we bring the platelet pathogen inactivation system to market," said Cerus President and Chief Executive Officer Stephen Isaacs. "While preclinical studies have shown our system effectively inhibits leukocyte activity, we believe that some physicians will continue to prescribe gamma irradiated platelets for certain patients. As a result, we wanted data to support the compatibility of our system with the gamma irradiation process."
Cerus Corporation is developing proprietary systems designed to enhance the safety of blood transfusions by inactivating infectious pathogens in blood components used for transfusion (platelets, fresh frozen plasma (FFP), and red blood cells) and by inhibiting the white blood cell activity that is responsible for certain adverse reactions to transfusions. The Company recently announced FDA Clearance of the protocol for its Phase 2c trial set to commence later this summer; and has subsequently received Institutional Review Board (IRB) approval from the study site. The Company is also actively engaged in a Phase 1 trial for its FFP pathogen inactivation system. The Company's platform technology, which inhibits replication of nucleic acid, has additional potential applications in health care fields beyond pathogen inactivation in blood components.
Cerus Corporation is collaborating with the Fenwal Division of Baxter Healthcare Corporation's Biotech Group to develop, manufacture and market pathogen inactivation systems for blood components used for transfusion. Baxter, a global medical products company, is a leader in technologies related to blood and the circulatory system. The Fenwal Division develops, manufactures and markets products and services for the collection, separation, storage and transfusion of blood and its components.
This news release contains forward-looking statements that involve risks and uncertainties. Actual results could differ materially from the above forward-looking statements as a result of certain factors, including FDA review of the Phase 2b study final report, uncertainty of future clinical trials, and other factors discussed in the Company's Prospectus dated January 30, 1997.
SOURCE Cerus Corporation
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