EXCLUSIVE: Cleveland BioLabs Irradiation Treatment Still In Testing But Available If Appropriate (CBLI)

Cleveland BioLabs CBLI has revealed that its drug to treat irradiation is yet to receive FDA approval as it is still in the testing phase, and so CBLI has no ability at present to market the drug.

However, Rachel Levine, Cleveland BioLabs' Director of Corporate Development and Communications, told Benzinga that the company has informed US agencies cooperating with Japan of the drugs existence, and that doses are available should emergency measures be approved.

“We are ready to assist,” said Levine. “It is in the hands of the appropriate agencies, if they feel it is appropriate to use the drug. The drug is in advanced development and we have done a lot of radiation testing on non-human primates and rodents. We have also tested the side effects of the drug on 150 healthy human volunteers. We will be doing a lot more testing before we submit for FDA approval, but we have been granted orphan drug status and fast-track designation.”