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news.Biotechnology company Crucell has reported that the company's rabies monoclonal antibody combination has entered a Phase II clinical trial in the US.
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At the beginning of 2008, Crucell has signed 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 combination with Sanofi Pasteur rabies vaccine for post-exposure prophylaxis against this fatal disease. The start of the Phase II study constitutes the first milestone in this agreement.
The clinical trial will be a randomized, single-blind, controlled study in 140 healthy volunteers that will test the antibody product in association with Sanofi Pasteur rabies vaccine and compare it to the currently marketed human rabies immune globulin or placebo, in association with rabies vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity.
Ronald Brus, Crucell’s CEO, said: “We are very pleased with our continued and rapid progress with this next generation rabies treatment. The swift development of this rabies monoclonal antibody product would be extremely valuable in reducing the global burden of this fatal disease.”