Singapore, Oct 21, 2009: Dutch biopharma company Crucell has announced that detailed results of the phase II Philippines study of its rabies monoclonal antibody combination (CL 184) were presented at the XX Rabies in the Americas (RITA) Conference in Quebec, Canada. The presentation was given by Dr Beatriz P Quiambao, Chief Clinical Research Division and Head, Rabies Research Group, Research Institute for Tropical Medicine, Muntinlupa, Philippines.

 

In June 2009, Crucell announced the results of the phase II Philippines study in healthy adolescents and children, which showed that the antibody combination was safe and well tolerated. Neutralizing activity levels in subjects given the antibody product were similar to those in subjects given human rabies immunoglobulin (HRIG), the current standard for inducing immediate, passive immunity. All study participants are said to have reached adequate immunity levels.

 

This study in a paediatric population, performed at the Research Institute for Tropical Medicine under the leadership of Dr Quiambao, is said to further broaden the potential patient population for Crucell's rabies monoclonal antibody combination.

 

"We are very pleased with the outcome of the Philippines phase II study as our children are at high risk of getting rabies. The progress with this next generation rabies treatment brings us closer to the moment when all-in-need will get adequate treatment against rabies." said Dr Quiambao.

 

This third phase II study will be carried out at Lotus Laboratories in Bangalore, India and is planned to start within the next six months. The rationale for this study is to collect safety and neutralizing activity data of the CL184 antibody in combination with the vaccine in a simulated rabies post-exposure prophylaxis setting to be used in phase III.

 

"We continue to push this program forward in order to bring a high quality rabies treatment to the market as soon as possible. Plans to start the third phase II clinical study are progressing well after recent approval received from the Drug Controller General of India." said Ronald Brus, CEO Crucell. "The market for Crucell's rabies monoclonal antibody combination is estimated to be significant with peak sales expected to exceed $300 million."

 

Crucell's monoclonal antibody combination against rabies is being developed in close collaboration with Sanofi Pasteur using Crucell's PER.C6 manufacturing technology. This antibody combination is designed to be used in combination with a rabies vaccine for post-exposure prophylaxis against this fatal disease.

 

In 2007 promising phase I data showed no serious adverse effects and demonstrated the expected rabies neutralizing activity upon administration. Positive results of the phase II US study were presented to rabies experts at the 19th annual RITA meeting in Atlanta on October 1, 2008.