A drug long-used to counter the negative effects of chemotherapy has won US Food and Drug Administration (FDA) approval for use in treating the nasty effects of exposure to radiation following a nuclear disaster. Known commercially as Neupogen, the drug has been shown to work by shielding the body's white blood cells to heighten a patient's chances of survival.
Neupogen, or filgrastim as it is otherwise known, is a synthetic protein that boosts the growth of infection-fighting white blood cells. Where the production of these cells is hampered in cancer patients by chemotherapy and radiation therapy, Neupogen can be used to stimulate the growth, maturation and release of white cells from the bone marrow. This better equips the sufferer to ward off infections and bleeding problems that can result from the therapy.
Neupogen was first approved for helping to treat those undergoing chemotherapy in 1991, and has since been one of a number of multi-purpose drugs investigated for potential use in the aftermath of nuclear disasters. But research conducted at the University of Maryland has now uncovered evidence worthy of the FDA's nod, making Neupogen the first drug to be approved as a countermeasure for Hematopoietic Acute Radiation Syndrome (H-ARS).
The scientists carried out their study in a non-human clinical model of high-dose radiation, with the FDA saying that, in the absence of ethical human studies, these animal studies were adequate and well enough controlled to suggest Neupogen is reasonably likely to be of benefit to humans suffering from H-ARS. This condition pertains to injuries to the bone marrow that slow the production of blood cells as a result of radiation exposure, and carries the risk of death from infection and haemorrhaging. But the FDA says that Neupogen can effectively minimize the severity and recovery time of such conditions.
"Our research shows that this drug works to increase survival by protecting blood cells," says Dr Thomas MacVittie, professor at the University of Maryland's School of Medicine. "That is a significant advancement, because the drug can now be used as a safe and effective treatment for the blood cell effects of severe radiation poisoning."
Sources: University of Maryland, FDA
There lead compound has performed well in animal safety studies, been well-tolerated in two human clinical trials, demonstrated efficacy in two species in acute radiation syndrome (ARS) studies and demonstrated statistically significant survival efficacy in an acute radiation-induced lung injury model.
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