LEIDEN, NETHERLANDS -- (Marketwire) -- 06/24/09 -- Dutch biopharmaceutical
company Crucell N.V. (Euronext, Nasdaq: CRXL) (SWISS: CRX)
today 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 on 18-23 October 2009.
"Our children are at high risk of getting rabies.
