Crucell Announces Positive Results of Phase II Rabies Monoclonal Antibody Combination Clinical Study in Philippines
Crucell N.V. announced the results of a second phase II clinical study of its investigational rabies monoclonal antibody combination, which started in May 2008 in the Philippines. Crucell has a collaboration and commercialization agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for Crucell's rabies monoclonal antibodies to be used in association with a rabies vaccine for post-exposure prophylaxis against the fatal disease of rabies.
This phase II trial was set up as a randomized, single-blind, controlled study in 48 healthy children and adolescents in a high endemic area of Metro Manila, Philippines. The trial was set up to test the safety and tolerability of the antibody product in association with sanofi pasteur's Verorab® rabies vaccine in a direct comparison with the marketed human rabies immune globulin (HRIG) product. It was performed at the Research Institute for Tropical Medicine under the leadership of Dr Beatriz P. Quiambao. The antibody product in association with the rabies vaccine was administered to 16 adolescents as well as 16 children. Its safety and neutralizing activity was compared to HRIG associated with the same rabies vaccine in 8 adolescents and 8 children. The results of the Philippines study showed Crucell's rabies monoclonal antibody combination was safe and well tolerated. Neutralizing activity levels were similar in the subjects administered with the antibody product or with HRIG and all study participants reached adequate immunity levels. This study in children further broadens the population in which Crucell's rabies monoclonal antibody combination could potentially be used. Earlier trials in adult populations have already shown safety and neutralizing activity. Detailed results of this study will be presented at the XX Rabies in the Americas RITA conference in Quebec, Canada.
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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
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