CBLB502CBLB502 is the Company’s Radiation Antidote
Cleveland BioLabs Protectan CBLB502 Demonstrated Strong Survival Benefits as a Mitigator against Radiation-Induced Damage in Study
CBLB502 is the first compound to provide protection from both gastrointestinal and hematopoietic radiation-induced damage when administrated before or after irradiation. Moreover, mitigation shown in two animal species opens much broader potential markets for CBLB502's use as a radiation antidote."
The Company is submitting Protectan CBLB502 to the Department of Defense (DoD) in response to a recently published Request for Proposal (RFP) for medical radiation countermeasures to treat gastrointestinal effects of acute radiation syndrome. The RFP 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. Cleveland BioLabs is in the process of completing Good Manufacturing Practices compliant (cGMP) manufacturing of Protectan CBLB502 and plans to submit an Investigational New Drug (IND) application for a human safety study later this year.