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Buffalo firm's anti-radiation drug increases survival rates, study says

Cleveland BioLabs said a recent clinical study on nonhuman primates has yielded strong results that indicate its Protectan anti-radiation sickness drug can increase survival rates following a potentially lethal exposure to radiation.

The Buffalo-based company said Monday that 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.

"We are very pleased with the compelling survival data," said Ann Hards, the company's executive vice president.

The news sparked a strong rally in Cleveland BioLabs' battered stock, which had lost 74 percent of its value over the past year before Monday. The shares jumped 61 percent on Monday, before falling back 13 percent, or 27 cents, on Tuesday to close at $1.80.

Cleveland BioLabs executives said the results will be used to further the company's efforts to obtain approval for the drug from the U.S. Food and Drug Administration. They also said the results will help determine the proper dosage levels that would be needed to use the drugs on humans.

"We are as committed as ever to moving this program forward," said Yakov Kogan, Cleveland BioLabs' interim chief executive officer.

Cleveland BioLabs has been focusing 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.

Using the drug as a cancer treatment, however, is expected to take longer than the more advanced efforts to gain approval for using Protectan as an emergency treatment for radiation sickness on the battlefield or other situations, such as a terrorist attack or severe nuclear accident.

The company said last month it had reached an agreement with the Food and Drug Administration on most of the major questions that the regulators had about the structure of its animal-testing studies for Protectan.

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