Baxter and Cerus Halt Red Blood Cell Clinical Trials for Investigational Pathogen Inactivation System
Cerus Corporation and subsidiaries of Baxter International Inc. announced they are voluntarily halting Phase III trials for their pathogen-inactivated red blood cell program. The companies made this decision as a precautionary measure after two study patients developed antibodies to red blood cells treated with S-303, the compound used in the companies' investigational pathogen inactivation system for red blood cells.
The two patients who were enrolled in the Phase III trial showed an antibody response but no clinical adverse events after transfusion with the S-303 treated red blood cells. The antibody response was discovered using a standard blood test that was employed as part of the clinical protocol. Antibodies are known to arise in transfused patients and may not be physiologically active.
The observations from this trial do not affect the development or commercialization of the pathogen inactivation programs for platelets and plasma, which use a different technology and mechanism of action. The red blood cell technology employs a compound called S-303, which is activated by the pH of blood. The platelet and plasma technology uses a compound called S-59 (or amotosalen), which is activated by light. There is extensive, published data on the safety profile of the platelet and plasma technology, including the amotosalen compound, documenting no associated antibody response.
The companies plan to evaluate the available clinical data to determine the appropriate course of action for their investigational pathogen inactivation system for red blood cells.
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Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
