GASTROINTESTINAL ACUTE RADIATION SYNDROME (GI-ARS)

There is heightened awareness that the US population is susceptible to exposure to radiation, either by industrial mishap or national security breach. Damage to the gastrointestinal tract is one of the primary causes of morbidity and mortality following radiation exposure. A safe and effective treatment agent would play an important role in treating individuals exposed to high levels of ionizing radiation. Such an agent might be delivered alone, or in association with a separate agent to address the deleterious effects of radiation on bone marrow.

Avaxia is developing an orally delivered anti-TNF antibody as a nuclear threat medical countermeasure for gastrointestinal acute radiation syndrome under a contract with the US Government's Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

The antibody product is to be stockpiled for use as a treatment agent for people exposed to radiation following a nuclear accident, attack or explosion. Avaxia's GI-ARS product will be a polyclonal anti-TNF antibody formulated as a dried powder sachet that is stable at room temperature and is reconstituted immediately before use. Dosing begins as soon as is practicable after radiation exposure.