Cerus Corporation (Nasdaq: CERS) today announced that it has received Food and Drug Administration clearance to proceed with a pilot patient safety and efficacy study of its proprietary platelet pathogen inactivation system. This single site, Phase 2c trial will involve 15 patients requiring platelet transfusions, typically as a result of chemotherapy for cancer. The study is expected to commence this summer, pending approval of the trial site's Institutional Review Board (IRB).
"Following consultation with the FDA in mid-February, we elected to conduct a pilot study before commencing a Phase 3 clinical trial of our proprietary platelet decontamination system in the U.S.," said Cerus President and Chief Executive Officer Stephen Isaacs. "We are encouraged that the FDA concurs with the design of the pilot study and look forward to commencing in the coming weeks."
Cerus Corporation is developing proprietary systems designed to improve 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 is presently in Phase 2b trials with its pathogen inactivation system for platelets and is actively engaged in Phase 1 trials for its FFP system. The Company's platform technology, which inhibits replication of nucleic acid, has additional potential applications in the 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 the timing and content of the response of the trial site's IRB to the Company's request to conduct the Phase 2c trials well as other factors discussed in the Company's Prospectus dated January 30, 1997.
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