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Cleveland BioLabs optimistic on Protectan; CEO cites new study on anti-radiation drug

Cleveland BioLabs chief executive Yakov Kogan thinks the Buffalo drug development company's business is beginning to mature.

Cleveland BioLabs got a big boost earlier this month when it released the results of a recent clinical study on nonhuman primates indicating that its Protectan anti-radiation sickness drug can greatly increase survival rates following a potentially lethal exposure to radiation.

The test on 179 primates found a 75 percent survival rate among those that received a dose of Cleveland BioLabs' Protectan 502 drug 25 hours after the exposure, while the primates that were given a placebo had only a 27.5 percent survival rate. The survival rates were determined 60 days after the exposure.

"The data talks for itself," Kogan said following the company's annual shareholder's meeting.

"These results will be extremely valuable in cementing [Protectan] 502's position as the most advanced anti-radiation countermeasure," said Kogan, who lost the "interim" part of his CEO title on Wednesday when he was named permanent CEO.

Kogan said the study's results were encouraging because they also indicated that Protectan 502 can do more than merely keep the victims of radiation exposure alive.

"It's not only survival, but the quality of life would be restored . . or very much improved," he said.

Kogan believes the study was a key step forward in Cleveland BioLabs' efforts to develop Protectan into a commercially viable drug. The company's initial efforts are focusing on its military and homeland security applications in situations such as a terrorist attack or a nuclear accident, but the drug also has shown promise as a cancer treatment, although those development efforts are less advanced.

Neil Lyons, Cleveland BioLabs' chief financial officer, said the company has a little more financial breathing room after reducing the amount of cash it burns through each month by at least a third, to around $800,000.

Those savings were achieved by delaying a clinical trial for Protectan as a cancer treatment, slowing some investments in some of Cleveland BioLabs' other drugs and general belt tightening, he said.

The result, however, should give Cleveland BioLabs enough cash to fund its operations through June 2013, about six months longer than its cash would have lasted without the changes, Kogan said. Because Cleveland BioLabs' drugs are not ready to be sold commercially, the company relies on funds raised through investors and government grants to fund its operations.

The slower cash burn rate also should leave Cleveland BioLabs with enough money to fund the next steps in Protectan 502's development as a radiation sickness drug, including the completion of animal and human safety studies during 2013. The company hopes to be able to seek approval for the drug from the U.S. Food and Drug Administration sometime during 2014.

Kogan said he believes the company is "progressing forward" in its talks with FDA officials, who have raised questions about the structure of the company's animal testing studies for Protectan.

FDA officials will be reviewing the results of the latest study, and Kogan said company officials expect to meet with the FDA again this summer.

The questions from the FDA over the design of its trials has been a key issue hanging over Cleveland BioLabs for more than a year. A key federal funding source, the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority, has declined to fund key future trials until it receives clarification that the path the company is following to obtain approval for Protectan is one the FDA believes is the right one.

"I have high confidence in the way the study was designed," Kogan said. "I believe enormous work was done."