by
Brendon Nafziger, DOTmed News Associate Editor | June 15, 2011
As for humans, the company said on its website that two safety trials, with about 70 volunteers, have been done. No serious or unexpected adverse events were discovered, Humanetics said.
But unlike with other drugs, efficacy studies likely would never be performed on humans, as volunteers can't be subjected to ionizing radiation. Instead, the FDA's so-called two-animal rule would likely apply, where the efficacy would have to be proved in two separate animal species.

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From its current research, the company suggests Bio 300 would probably be given as a prophylactic. In an e-mail, Zenk said while Bio 300 is effective post-exposure for different harmful levels of ionizing radiation, post-exposure administration would not necessarily work for lethal exposures.
"With respect to CT scans and cancer radiotherapy applications, Bio 300 would likely be most effective if administered 24 hours before exposure to ionizing radiation," Zenk said.
But the company said it's designing its other anti-ARS drugs in the pipeline to be effective at different stages of exposure -- some more effective before, others after -- to have a broad range of options in emergencies.
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