by Brendon Nafziger
, DOTmed News Associate Editor | July 26, 2010
Cleveland Biolabs' experimental drug that could protect survivors from radiation poisoning following a nuclear bomb blast or power plant accident and ease chemotherapy treatments just got U.S. Food and Drug Administration's fast-track status, the company said July 22.
The fast-track program is designed to speed processing times for drugs to treat life-threatening ailments, the Buffalo, N.Y.-based company said. Currently, no FDA-approved drugs exist that protect the body from severe radiation exposure, known as acute radiation syndrome.
Fast tracking lets the agency review the drug's application as it comes in, rather than having to wait to receive the complete submission before looking it over. Drugs considered under this program also are eligible for an abbreviated, six-month review, the company said.
The drug, called CBLB502, is derived from molecules that make up flagella, bacteria's tendril-like appendages. The company says the drug protects the body from cell death, such as that caused by radiation or chemotherapy. Cleveland BioLabs hopes to market it as a biodefense drug as research suggests it protects animals from the deadly effects of acute radiation syndrome, such as the destruction of blood precursor cells in bone marrow and the lining of the gut.
"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," Cleveland BioLabs' president and CEO Michael Fonstein said in a statement.
In May, seven-year-old Cleveland BioLabs reported they had wrapped up a Phase 1b safety study
on about 100 human health volunteers showing the drug was safe, with only mild side effects, such as flu-like symptoms lasting a few hours after injections. The company plans on running a follow-up safety study with around 500 volunteers.
As efficacy studies require delivering sometimes fatal doses of radiation, the drug qualifies for the FDA's two-animal rule, meaning safety has to be shown in humans but effectiveness in two animal species. Efficacy studies have already been done in mice and monkeys, but the company said additional research will be required before approval.
"We see it all coming together in the first half of 2011," Fonstein told DOTmed News in May.
Cleveland's stock soared almost 11 percent on the fast-tracking news Thursday, but fell about 1 percent to close at $3.58 Friday on Nasdaq.