Cleveland BioLabs' Drug Protects Against Radiation-Induced Injury

Cleveland BioLabs has announced the results of its study of Protectan CBLB502's efficacy as a mitigator of radiation-induced gastrointestinal (GI) and hematopoietic injury in nonhuman primates.

In the study, Rhesus monkeys were irradiated with 6.5 Gy of total body irradiation and injected intramuscularly with either a single dose of Protectan CBLB502 or a placebo one hour after irradiation. No supportive therapy was applied. The animals were observed for 40 days. CBLB502 enabled survival of 70 percent of the animals in the protected group, versus the control group in which 20 percent of the animals survived. In addition, gross pathology results showed that the majority of control animals displayed severe damage to the GI tract, while the CBLB502-treated animals did not. This data demonstrates CBLB502's capacity as a mitigator of radiation-induced GI injury.

The company is submitting Protectan CBLB502 to the Department of Defense in response to a recently published request for proposal for medical radiation countermeasures to treat the GI effects of acute radiation syndrome. The contract award would provide funding for development of the countermeasure through FDA approval, as well as a commitment to purchase up to 500,000 doses thereafter.

Protectan CBLB502 is undergoing an accelerated development program under the FDA two-animal rule, which requires the company to show efficacy in two animal species and only safety in humans. The company plans to submit an investigational new drug application for a human safety study later this year.