* 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 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
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
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
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
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
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)