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Cleveland BioLabs upbeat as loss lessens

Cleveland BioLabs' first-quarter losses narrowed slightly to $5.4 million, as the Buffalo biotechnology company reported progress in talks with federal regulators over the direction of clinical studies for a key anti-radiation sickness drug that it's developing.

Yakov N. Kogan, Cleveland Bio-Labs's interim CEO, said company officials met with officials from the U.S. Food and Drug Administration last month and reached an agreement "on our most critical high-level questions" over animal testing of its Protectan anti-radiation sickness drug.

The design of those trials has been an important issue for Cleveland Bio-Labs for more than a year because a key federal funding source, the Biomedical Advanced Research and Development Authority, or BARDA, has declined to fund key future trials because of questions over the path the company is following to obtain approval for its Protectan 502 drug and whether the FDA believes that path is the right one.

"We believe that we have reached a common understanding on the design elements of the proposed clinical program and what those elements should look like," Kogan said.

Cleveland BioLabs executives plan to develop final plans for the animal tests and then meet with FDA officials before the end of summer "to confirm its specifics."

Kogan said the company plans to work on proposals for funding from BARDA and other federal agencies.

Cleveland BioLabs' primary focus has been on developing its Protectan drug as a treatment for radiation sickness, especially in military and homeland security situations. The company also is working to develop its drugs as potential cancer treatments.

That type of commercial use, however, is expected to take longer than the more advanced efforts to gain approval for use to develop Protectan as an emergency treatment for radiation sickness on the battlefield or other situations, such as a terrorist attack or severe nuclear accident.