Boston, Mass. MassBiologics of the University of Massachusetts Medical School today announced the beginning of a Phase 1 clinical trial, testing the safety and activity of a human monoclonal antibody (MAB) developed to neutralize the rabies virus.
The clinical trial is being conducted at the King Edward Memorial Hospital in Mumbai, India, and is sponsored by the Serum Institute of India, which is working in a collaborative partnership with MassBiologics to manufacture and test the new antibody.
"India is an appropriate location to do this study because of the serious problem of rabies that exists in the country," said Donna Ambrosino, MD, executive director of MassBiologics and a professor of pediatrics at the Medical School. "We look forward to seeing the results from this trial, and to advancing this potentially life-saving treatment."
Even though rabies-related deaths in the United States are rare, more than 40,000 people in the U.S. are exposed to the disease each year and require immediate treatment known as post-exposure prophylaxis (PEP). Worldwide, however, rabies remains a major public health problem. The World Health Organization estimates that at least 10 million people are exposed to rabid animals each year, resulting in some 55,000 deaths.
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. Unfortunately, hRIG, which is derived from human blood, is an expensive material and is often not available in developing countries. To compensate, 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 address the supply problems and side-effect issues, MassBiologics and the U.S
|Contact: Michael Cohen|
University of Massachusetts Medical School