Cleveland BioLabs is making a new pitch to federal officials to provide further funding for the testing and development of its anti-radiation sickness drug.
The Buffalo-based life sciences company said Thursday it has submitted a new proposal to the Biomedical Advanced Research and Development Authority, or BARDA, to fund the rest of the development program that, if successful, would allow its Entolimod’s anti-radiation sickness drug to gain approval from the Food and Drug Administration.
The federal agency had been a key source of funding for Cleveland BioLabs, which believes its drug could be a valuable treatment for radiation sickness in the event of a terrorist attack, nuclear power plant accident or use of nuclear weapons on the battlefield.
But BARDA backed away from providing additional funding for Cleveland BioLabs’ program more than a year ago because of questions about whether the FDA favors the path the company is following to obtain approval for its Entolimod drug. Cleveland BioLabs said last month that it has reached an agreement with the FDA on the shape of those clinical studies, clearing the way for the latest proposal from the company, although there is no guarantee BARDA will agree to any additional funding.
The drug has shown promise in earlier-stage tests in limiting the damage from exposure to radiation, but additional animal studies are required to measure its effectiveness and determine the proper dosage.
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.