Cerus Corporation (Nasdaq: CERS) today announced it has commenced a Phase I clinical trial of its proprietary photochemical system for inactivation of pathogens in plasma used for transfusion, also called fresh frozen plasma or FFP. The purpose of this study, which was recently given clearance to proceed by the Food and Drug Administration, is to establish the safety and tolerability in healthy subjects of FFP treated with the Company's pathogen inactivation system. The Company plans to begin efficacy studies in early 1998, following satisfactory completion of the Phase I trial.
The trial is an escalating dose, randomized cross-over study, in which plasma will be drawn from 15 healthy subjects to produce control and treated plasma for subsequent reinfusion into the donor-subject. Following reinfusion, each subject will be monitored for responses to the transfusion. The trial is being conducted at the Veterans Administration Hospital at Stanford University Medical School in Palo Alto, California. The Company is presently in Phase IIb trials with the same proprietary compound (S-59) to inactivate infectious pathogens in platelets, which are often administered to patients undergoing chemotherapy regimens.
"Preclinically we have shown our compounds to inactivate a wide spectrum of pathogens potentially transmitted through blood transfusions, including HIV, hepatitis B and C, and other transfusion-associated pathogens," said Cerus President and Chief Executive Officer Stephen Isaacs. "The goal of all blood collection centers is to enhance and improve the safety of blood transfusion products. We have been extremely encouraged thus far by the results of our clinical trials in platelets, and are looking forward to the results from this FFP trial." Preclinical trials are underway on a related technology for inactivating pathogens in red cells.
Cerus Corporation is developing systems designed to improve the safety of blood transfusions by inactivating infectious pathogens in blood components used for transfusion (platelets, FFP and red blood cells) and by inhibiting the white blood cell activity that is responsible for certain adverse reactions to transfusions. The Company's platform technology, which inhibits replication of nucleic acid, has additional potential applications in the health care field 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 the timing of and the response of the FDA to the results of the Phase I trial and the design of subsequent trials for the FFP pathogen inactivation system, as well as other factors discussed in the Company's Prospectus dated January 30, 1997.
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