Donate to Science & Enterprise

S&E on Mastodon

S&E on LinkedIn

S&E on Flipboard

Please share Science & Enterprise

Acute Radiation Syndrome Drug Granted FDA Fast Track Status

Cleveland BioLabs Inc., a biotechnology company in Buffalo, New York, today announced that CBLB502, a drug developed for the treatment of acute radiation syndrome (ARS), has been granted fast track status by the U.S. Food and Drug Administration (FDA).

CBLB502 is derived from a microbial protein that can reduce injury from acute stresses, such as radiation and chemotherapy, by mobilizing several natural cell protective mechanisms. FDA’s fast track program expedites the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need.

The company says CBLB502 is being developed under the FDA’s Animal Efficacy Rule to treat ARS or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon (e.g., “dirty bomb”), or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety, and various testing protocols in healthy human volunteers.

1 comment to Acute Radiation Syndrome Drug Granted FDA Fast Track Status