The United States has fast-tracked a new drug that aims to cut down possible radiation risks from a likely nuclear disaster like an explosion in a plant or even a nuclear war.

The experimental drug code-named CBLB502 claims to reduce the risk of death following total body irradiation during or after a radiation disaster.

CBLB502 is a derivative of a microbial protein that potentially reduces injury from acute stress, such as radiation and chemotherapy. It works by mobilizing several natural cell protective mechanisms, including inhibition of programmed cell death. It also reduces the oxidative damage and induction of regeneration-promoting substances in the cell.

CBLB502 has been developed by Cleveland BioLabs to treat Acute Radiation Syndrome (ARS) or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon / dirty bomb, or from a nuclear accident.

The US Food and Drug Administration (FDA) has a Fast Track program that focuses on expediting the review of investigational drugs for treatment of patients with serious or life-threatening diseases.

Fast Track designations permit the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. A fast track development program also makes the drug eligible for priority review. This automatically shortens the review time from the prescribed six months.

Cleveland has already published CBLB502's mechanism of action and activity in animals in the April 2008 issue of Science Magazine. Thereafter research conducted upon 50 human subjects also indicated that CBLB502 was well tolerated.

While trials on another group of 100 volunteers as part of the second human safety study for CBLB502 was completed in May, the safety analysis of the trial data is currently going on. As on date, there is no FDA approved therapy to reduce the risk of death following total body irradiation.

"We are extremely pleased that the lead indication for CBLB502 has been assigned Fast Track status, and look forward to working closely with the FDA to expedite the program's review process," says Michael Fonstein, Ph.D., President and Chief Executive Officer of Cleveland BioLabs.

Cleveland BioLabs, Inc has strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute, ChemBridge Corporation and the Armed Forces Radiobiology Research Institute.