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Cleveland BioLabs shares jump

Drug may have role in Japan N-crisis

By David Robinson
NEWS BUSINESS REPORTER
Published:March 15, 2011, 12:00 AM

Cleveland BioLabs shares jumped by 10 percent Monday as the crisis at Japan’s nuclear power plants focused investors’ attention on the Buffalo biotechnology company’s anti-radiation sickness drug.

Cleveland BioLabs currently is conducting studies on the safety and effectiveness of its Protectan drug, which has shown promise in previous clinical trials. Those clinical trials so far have shown that the drug can be effective if administered as long as 48 hours after initial exposure.

The side effects of Protectan have been described as largely mild or moderate during the early trials. Participants in the trial found that flu-like symptoms — the most common side effect — went away within two to four hours, Cleveland BioLabs executives have said.

Michael Fonstein, Cleveland BioLabs’ president and chief executive officer, said the company has been in touch with U. S. government health agencies to offer doses of Protectan that could be used if there was a catastrophic radiation leak from the troubled Japanese nuclear plants.

“Obviously, our drug is highly relevant. However, it is unlicensed,” Fonstein said. “We have doses of the drug that can be made available, with the understanding that this is not an approved drug.”

Fonstein said U. S. officials have not indicated whether they would consider Cleveland BioLabs’ offer to provide its unapproved drug in an emergency.
“So far, it’s just been a sharing of information,” said Rachel Levine, a company spokeswoman.

Cleveland BioLabs shares jumped by 75 cents Monday to close at $7.94 the highest closing price since the beginning of January 2008. The shares have jumped 14 percent since the close of trading Thursday, the day before the earthquake.

The drug, while on a fast track to be considered for approval by the U. S. Food and Drug Administration, is not expected to be granted clearance until mid-2012 at the earliest.