Crucell Announces Start of Phase II Clinical Study Rabies Monoclonal Antibody Combination in US
First Milestone Achieved in Collaboration Agreement with Sanofi Pasteur
Leiden, The Netherlands, - Dutch biotechnology company Crucell N.V. today announced that its rabies monoclonal antibody combination has entered a Phase II clinical trial in the United States. At the beginning of the year, Crucell announced it had 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.
“We are very pleased with our continued and rapid progress with this next generation rabies treatment,” said Ronald Brus, Crucell’s Chief Executive Officer. “The swift development of this rabies monoclonal antibody product would be extremely valuable in reducing the global burden of this fatal disease.”
Sanofi Pasteur is the worldwide market leader in providing biologicals for pre- and post-exposure prophylaxis against rabies. In the last 20 years, over 20 million people in 100 countries have been treated with sanofi pasteur’s rabies products.
This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on June 13, 2007, and the section entitled “Risk Factors”. The Company prepares its financial statements under generally accepted accounting principles in the United States (US GAAP) and Europe (IFRS).
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