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First human gets new antibody aimed at rabies virus
Date:9/30/2009

. Centers for Disease Control and Prevention launched an effort to develop a MAB that could be used in place of hRIG. The research used, in part, HuMab mice from Medarex, Inc. (Princeton, N.J.) which are transgenic mice able to produce fully human antibodies. Pre-clinical testing of the new MAB showed that it neutralized all isolates available from a panel of rabies viruses.

"Too often physicians in India and other developing countries only have the rabies vaccine to offer, and that alone isn't always enough to prevent infection," said Deborah Molrine, MD, deputy director of clinical and regulatory affairs at MassBiologics and an associate professor of pediatrics at the Medical School, who helped design the clinical trial and will oversee the analysis. "If this new antibody proves effective in people, it will have a tremendous impact on saving lives."

In the Phase 1 trial just launched in India, a total of 84 healthy volunteers will receive various doses of the new MAB to test the tolerability and biologic activity of the MAB in people. The site investigators will monitor the volunteers' overall health and do clinical laboratory testing for safety. Scientists at MassBiologics will test blood samples drawn from the volunteers to measure the amount of MAB in the bloodstream, and to see if the volunteers produced any of their own antibodies directed against the new MAB. Scientists from the Kansas State Veterinary Diagnostic Laboratory will test the blood samples against the rabies virus in culture, to determine the dose of MAB administered to the volunteers that gave the best protective response.

The Serum Institute of India is the world's largest manufacturer of vaccines and is a major supplier of the rabies vaccine. Scientists from the MassBiologics worked with their counterparts in India to help the Serum Institute build its own internal MAB production facility, thereby bringing this leading-edge biologics technology to India for the
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Contact: Michael Cohen
Michael.Cohen@umassmed.edu
508-856-2000
University of Massachusetts Medical School
Source:Eurekalert

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