Gert van der Hoek
In Memoriam - Editor, Senior Moderator
Crucell presents Phase I results rabies antibody cocktail showing safety and ability to protect
Leiden, The Netherlands, October 3, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced the results of the first clinical evaluation of the Rabies monoclonal antibody cocktail, a combination of two human monoclonal antibodies.
Data from the First-in-Man Phase I study conducted in the US indicates that the cocktail is well tolerated, provides the expected neutralizing activity and that it can be administered in combination with rabies vaccine.
Crucell is developing this human monoclonal antibody cocktail for the post-exposure prophylaxis of rabies, using its MAbstract? and PER.C6? technologies.
Details regarding the US Phase I trial data are presented today by Dr. Alexander Bakker at the XVIII Rabies in the Americas RITA conference in Guanajuato City, Mexico.
The clinical trial was a randomized, double-blind, placebo controlled study in healthy volunteers that tested the human monoclonal antibody cocktail against rabies alone, in a dose escalation, as well as in combination with 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 all dose levels that were administered.
In the second, open, part of the study, in which the rabies antibody cocktail was administered in combination with rabies vaccine, all volunteers seroconverted within 14 days upon the initiation of treatment, which means a level of rabies virus neutralizing activity that is considered to provide protection against the deadly virus (i.e. > 0.5 IU/mL) was achieved.
This shows that the antibody cocktail can be safely co-administered inline with standard therapy.
"Given the unmet medical need in rabies, we are committed to move as fast as possible; people deserve to be protected against rabies," said Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell. "The continued progress of the phase I clinical trial provides further validation of our PER.C6? and MAbstract? technologies."
Data from the Phase I clinical trial in India, to assess safety and efficacy, will be reported during the Joint International Tropical Medicine Meeting 2007 on November 30, 2007 in Bangkok, Thailand.
Crucell meanwhile has contracted DSM Biologics, its alliance partner for the PER.C6? technology platform, for the process validation and manufacturing of antibody batches for Phase III clinical efficacy studies.
http://cws.huginonline.com/C/132631/PR/200710/1157795_5_5.html
Presentation:
http://hugin.info/132631/R/1157802/223783.pdf
Leiden, The Netherlands, October 3, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced the results of the first clinical evaluation of the Rabies monoclonal antibody cocktail, a combination of two human monoclonal antibodies.
Data from the First-in-Man Phase I study conducted in the US indicates that the cocktail is well tolerated, provides the expected neutralizing activity and that it can be administered in combination with rabies vaccine.
Crucell is developing this human monoclonal antibody cocktail for the post-exposure prophylaxis of rabies, using its MAbstract? and PER.C6? technologies.
Details regarding the US Phase I trial data are presented today by Dr. Alexander Bakker at the XVIII Rabies in the Americas RITA conference in Guanajuato City, Mexico.
The clinical trial was a randomized, double-blind, placebo controlled study in healthy volunteers that tested the human monoclonal antibody cocktail against rabies alone, in a dose escalation, as well as in combination with 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 all dose levels that were administered.
In the second, open, part of the study, in which the rabies antibody cocktail was administered in combination with rabies vaccine, all volunteers seroconverted within 14 days upon the initiation of treatment, which means a level of rabies virus neutralizing activity that is considered to provide protection against the deadly virus (i.e. > 0.5 IU/mL) was achieved.
This shows that the antibody cocktail can be safely co-administered inline with standard therapy.
"Given the unmet medical need in rabies, we are committed to move as fast as possible; people deserve to be protected against rabies," said Dr. Jaap Goudsmit, Chief Scientific Officer at Crucell. "The continued progress of the phase I clinical trial provides further validation of our PER.C6? and MAbstract? technologies."
Data from the Phase I clinical trial in India, to assess safety and efficacy, will be reported during the Joint International Tropical Medicine Meeting 2007 on November 30, 2007 in Bangkok, Thailand.
Crucell meanwhile has contracted DSM Biologics, its alliance partner for the PER.C6? technology platform, for the process validation and manufacturing of antibody batches for Phase III clinical efficacy studies.
http://cws.huginonline.com/C/132631/PR/200710/1157795_5_5.html
Presentation:
http://hugin.info/132631/R/1157802/223783.pdf
