Crucell: Start of Phase II Clinical Study for Rabies Monoclonal Antibody Combination in the Philippines

15-May-2008

Crucell N.V. announced that its rabies monoclonal antibody combination product has entered a second phase II clinical study in the Philippines. On 31 March 2008 the company announced the start of a first phase II clinical study in the U.S.

The second phase II clinical trial will be a randomized, single-blind, controlled study in 48 healthy adolescents and children. The study will test the rabies monoclonal antibody combination product in association with sanofi pasteur's rabies vaccine and will compare it to the human rabies immune globulin, which is currently administered with the vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity. This clinical trial aims to generate safety data in children in Asia, complementing the safety data generated in adult volunteers during a phase I trial conducted in India. Jointly, the combined data allows a swift phase III clinical evaluation of the monoclonal antibody combination in individuals exposed to rabies in endemic areas like Asia.

"We are clearly on a fast track with the development of this new rabies treatment", said Ronald Brus, Crucell's Chief Executive Officer. "Our rabies antibody combination product is highly suitable to replace the currently used serum-based products. This antibody product can be produced in sufficient quantities to cover public and private sectors needs by the use of our PER.C6® technology. Expanded product availability would clearly help combat the supply restrictions of serum-based immune globulin products. The continued rapid development of our rabies antibody product in combination with sanofi pasteur's rabies vaccine can therefore considerably reduce the global burden of this fatal disease. "

https://www.bionity.com/en/news/82062/crucell-start-of-phase-ii-clinical-study-for-rabies-monoclonal-antibody-combination-in-the-philippines.html