A clinical trial to test the safety and activity of a human monoclonal antibody (MAB) has been launched in King Edward Memorial Hospital in Mumbai, India. MAB was developed to neutralize the rabies virus.
Serum Institute of India is working in a collaborative partnership with researchers from University of Massachusetts to manufacture and test the new antibody that would help treat people bitten by rabid animals.
"India is an appropriate location to do this study because of the serious problem of rabies that exists in the country," said Dr Donna Ambrosino, executive director of MassBiologics and a professor of pediatrics at the Medical School.
The rabies virus can cause acute encephalitis that is fatal once symptoms appear; however the infection is preventable by prompt treatment following exposure.
By using a rabies vaccine and human rabies immune globulin (hRIG) soon after exposure, patients are protected from the fatal disease.
However, hRIG, which is derived from human blood, is an expensive material and is often not available in developing countries.
Therefore, equine immune globulin derived from horse serum is used in many parts of the world but it also can be scarce and it can carry significant side effects.
To compensate, researchers have launched an effort to develop a MAB that could be used in place of hRIG.
During the study, 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.
In the Phase 1 trial 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.
"If this new antibody proves effective in people, it will have a tremendous impact on saving lives," said Dr Deborah Molrine, deputy director of clinical and regulatory affairs at MassBiologics and an associate professor of pediatrics at the Medical School.