Cleveland BioLabs has reached an agreement with the U.S. Food and Drug Administration on the shape of the clinical studies the Buffalo life sciences company needs to do to win approval for a key anti-radiation sickness drug.
The agreement, outlined in an advice letter from the FDA, is a significant development for Cleveland BioLabs because some of its key federal funding sources have been reluctant to commit more money to the company to fund those essential studies until it was certain that they were designed in a way that satisfied federal regulators.
"We are pleased with both our progress and the constructive nature of our recent interactions" with the FDA, said Ann Hards, Cleveland BioLabs' executive vice president, in a statement Monday.
The agreement covers plans for important clinical studies on animals to measure the effectiveness of Cleveland BioLabs' anti-radiation sickness drug, now called Entolimod.
The drug has shown promise in earlier stage tests in limiting the damage from exposure to radiation, adding weight to the hopes Cleveland BioLabs executives that Entolimod could be a valuable medication in the event of a terrorist attack, nuclear accident or other occurrences that result in potentially fatal radiation exposure.
In June, Cleveland BioLabs said a study on 179 primates found a 75 percent survival rate among those that received a dose of Entolimod 25 hours after being exposed to potentially lethal amount of radiation, while the primates that were given a placebo had only a 27.5 percent survival rate. The survival rates were determined 60 days after the exposure.