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Clinical trial for rabies monoclonal antibody
Date:8/7/2012

int from this pivotal trial is met, a new therapy could become available to thousands of patients each year to prevent the too-often fatal outcome of this infection."

In a phase 1 trial at the King Edward Memorial Hospital (KEM) in Mumbai, India, 74 healthy volunteers were randomized into several groups that either received RMAb or of hRIG combined with vaccine. Results showed that the RMAb was well tolerated by all subjects, with no serious side-effects. A dose of RMAb was selected from this study that produced comparable levels of rabies virus neutralizing antibodies in the blood from volunteers who received RMAb and vaccine compared to those who received the standard regimen of hRIG and vaccine.

Based on these data, Serum Institute of India received regulatory approval to proceed with the current pivotal trial. Final results from the current study are expected in the second half of 2013. The trial is registered with Clinical Trials Registry-India (CTRI /2012/05/002709).


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Contact: Mark L. Shelton
mark.shelton@umassmed.edu
508-856-2000
University of Massachusetts Medical School
Source:Eurekalert

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