Crucell Presents Indian Phase I Rabies Antibody Cocktail Study
Positive Results Enable Prompt Progression Towards Phase II Studies
Crucell N.V. announced the results of the second clinical evaluation of their rabies monoclonal antibody cocktail. Data for the Phase Ib study conducted in India which started in April 2007 indicate that the cocktail is well tolerated, provides the expected neutralizing activity and that it can be safely administered in combination with a rabies vaccine. The results were presented by Dr. Christophe Python at the Joint International Tropical medicine Meeting 2007 in Bangkok, Thailand.
The clinical trial was a randomized, double-blinded, placebo controlled study in healthy volunteers that tested the human monoclonal antibody cocktail against rabies alone, in a dose escalation design, as well as in combination with a rabies vaccine. In the first, blinded, part of the study, in which solely the antibody cocktail was given, rabies virus neutralizing activity could be demonstrated at both dose levels that were administered. In the second, open part of the study, in which the rabies antibody cocktail was administered in combination with a rabies vaccine, all volunteers seroconverted within 14 days upon the initiation of treatment. A level of rabies virus neutralizing activity (i.e. > 0.5 IU/mL) was achieved that is considered to provide protection against the deadly virus, thus proving that the antibody cocktail can be safely co-administered in line with standard therapy.
The data from the Indian study confirm and extend the results of the first-in-human Phase I study conducted in the US, which was presented on 3 October 2007 at the XVIII Rabies in the Americas RITA conference in Mexico. The combined data from both Phase I studies prompt the progression towards Phase II studies which are expected to start in the first half of 2008 in the US and the Philippines.
"The positive results from both studies, together with the Fast Track designation for this antibody cocktail which we were awarded just recently, supports our commitment to moving as fast as possible to address the unmet medical need that exists for rabies," said Dr. Jaap Goudsmit, Chief Scientific Officer.
Crucell is developing the rabies antibody cocktail for the post-exposure prophylaxis of rabies. The antibody cocktail is a combination of two human monoclonal antibodies and is produced with the use of Crucell's MAbstract® and PER.C6® technologies. Based on market needs, peak sales for Crucell's rabies antibody cocktail are expected to exceed US$ 300 million.
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Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
