New radiation countermeasure to be tested on humans
As worries about radiation attack by terorists — whether on a large scale, or for the killing of a single individual, as was the case in the recent London poisioning of Alexander Litvinenko — the FDA approves human trials of new radiation countermeasure from a Minnesota company
Good news for Eden Prairie, Minnesota-based Humanetics Corporation: The U.S. Food and Drug Administration (FDA) has cleared the company’s request to begin Phase I human trials under an Investigational New Drug (IND) 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 may be caused by the exposure of the body to radiation resulting from a nuclear or radiological terrorist attack or from an accident at a nuclear facility. Exposure to radiation causes damage to bone marrow, resulting in decreased production of platelets and infection-fighting white blood cells. Despite mounting worries about terorist use of radiactive materials — on a large scale, or for the purpose of killing a single individual, as was the case in the recent London poisioning of Alexander Litvinenko — there are currently no drugs approved by the FDA for the prevention or treatment of ARS.
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 infection-fighting white blood cells in bone marrow resulting in reduced morbidity and mortality.
Humanetics is a privately held clinical-stage pharmaceutical company. The company concentrates on the development and commercialization of orally administered bioactive compounds for the prevention and treatment of diseases. The company has several proprietary compounds in preclinical or clinical stages of development in the areas of bioterrorism, Alzheimer’s disease, and obesity.
-read more at company Web site
