HUMANETICS TO BEGIN STUDIES OF RADIATION COUNTERMEASURE

Humanetics announced that the FDA has cleared its request to begin Phase I trials under an investigational new drug application for BIO 300, a radiation countermeasure. Humanetics is seeking approval to market BIO 300 as a new oral drug for the prevention and prophylactic treatment of acute radiation syndrome (ARS).

ARS is a potentially lethal condition that may be caused by whole-body exposure to radiation resulting from a nuclear or radiological attack or from an accident at a nuclear facility. Exposure to radiation causes injury to bone marrow, resulting in decreased production of platelets and infection-fighting white blood cells. Currently, there are no drugs approved by the FDA for the prevention or treatment of ARS, according to Humanetics.

BIO 300 is a single molecular agent that can be self-administered. This oral drug, when taken prophylactically, has the potential to ameliorate the effects of ARS-related damage, including damage to progenitors of platelets and white blood cells in bone marrow. BIO 300 may achieve this effect through several mechanisms of action.

The ability of BIO 300 to protect against radiation-induced lethality was discovered by researchers at the Armed Forces Radiobiology Research Institute (AFRRI). Humanetics obtained a worldwide exclusive license to commercialize BIO 300 and has been working with researchers at AFRRI for several years to develop BIO 300 and other agents to prevent and treat ARS.