U.S. invests in drug to protect against radiation

Fri Sep 17, 2010 4:12pm EDT

* Cleveland BioLabs drug would be first of its kind

* CEO sees FDA approval by mid-2012

* Shares close up nearly 7 percent

By Julie Steenhuysen

CHICAGO, Sept 17 (Reuters) - Tiny biotech Cleveland BioLabs Inc (CBLI.O) has won a $45 million contract from the Department of Defense to conduct clinical trials of a drug to prevent cell damage in the event of nuclear attack.

The experimental drug has already been shown to protect mice and monkeys from the damaging effects of radiation.

If it works in people, it would be the first drug of its kind.

In animals, the drug has been shown to protect bone marrow and cells in the gut from being destroyed by radiation.

"There are no drugs which protect humans from radiation," Michael Fonstein, the company's chief executive officer, said in a telephone interview.

The drug works by interfering with a process of programmed cell death called apoptosis -- basically a form of cell suicide. This helps the body rid itself of damaged cells,

Fonstein said interfering with this process appears to strengthen the body's ability to recover from radiation exposure.

The contract with the Defense Department will give the company $14.8 million to develop the drug. It includes an option for the government to spend $30 million on the drug if it wins U.S. regulatory approval.[ID:nSGE68G0I9].

The company already is on a fast-track with the U.S. Food and Drug Administration to have its drug sped through the regulatory approval process.

Fonstein said the drug, known as CBLB502, could be approved for use in humans by mid-2012. That gives the company most of 2011 to ramp up manufacturing, complete animal and safety studies, giving the FDA another six months to complete its review.

The compound is made from a salmonella protein that naturally makes cells resistant to cell suicide.

The immediate application is for use as an emergency treatment for radiation exposure.

"This is the first product that is close to completion of the scientific studies for protecting populations that might be exposed to (radiation fallout)," Rear Admiral Craig Vanderwagen, a former official at the U.S. Department of Health and Human Services who has advised the company.

He said the drug is intended to protect the public in the event of a dirty bomb or a Chernobyl-like accident.

"Unfortunately, we are living in a crazy world where the threat of radiation as a result of a nuclear terrorist attack or a nuclear accident at a nuclear power plant is real," Fonstein said. "Obviously, it would be nice to have some countermeasures."

But the company also hopes to start clinical trials this fall to test the drug as a treatment to protect cancer patients undergoing radiation therapy.

"Sixty percent of cancer patients are treated with radiation. Those people would benefit from the drug," Fonstein said.

In animal studies, a single dose of the company's drug given shortly before radiation therapy significantly reduced damage to animals' sensitive bone marrow and gastrointestinal cells and prolonged their survival.

The drug also improved survival of mice when given an hour after the animals got a dose of radiation.

Shares of the company closed up 34 cents, nearly 7 percent, at $5.21 on Friday on NASDAQ. (Reporting by Julie Steenhuysen; editing by Carol Bishopric)

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