Cleveland BioLabs announced last week it got a patent for a drug that could protect people from radiation sickness, possibly saving lives in the aftermath of a nuclear power plant accident or radioactive "dirty" bomb attack.

The U.S. Patent and Trademark Office issued US Patent No. 7,638,485, known as "Modulating Apoptosis," for aspects of Cleveland's therapy to protect mammals from radiation exposure.

A so-called Protectan, the drug's active compound, CBLB502, is made from molecules derived from the flagella of bacteria, the tendril-like appendages microbes use to move around.

In addition to preventing radiation sickness, technically known as Acute Radiation Syndrome, Cleveland claims it could also help eliminate symptoms from radiotherapy or chemotherapy and possibly diminish the lethality of heart attacks or stroke.

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The Buffalo, N.Y.-based company has filed two additional patents on the drug, and is now gearing up to face the FDA's clinical requirements.

According to Cleveland, because it is ethically impossible to do radiation exposure tests on human subjects, the drug qualifies for the FDA's so-called two-animal rule, where the drugmakers have to show efficacy in two animal species and only safety in humans.

Michael Fonstein, Cleveland's CEO and president, tells DOTmed News that Cleveland met with the FDA around a month ago, and are working on developing the human safety trials and the two new animal studies, which should get underway this year.

But there have already been nearly a score of animal studies, Fonstein says, mostly on monkeys and mice, including one published in the prestigious journal Science almost two years ago, indicating what the drug can do.

In one 2007 experiment, scientists irradiated two groups of Rhesus monkeys, some injected with the Protectan and some not, with a 6.5 Gy dose of ionizing radiation. By comparison, the so-called LD50 for humans, the lethal dose of radiation that would kill half of all humans exposed, is thought to be around 2.5 to 5 Gy, according to the Centers for Disease Control.

The scientists then observed the primates for 40 days, as it can take weeks or months for the deadly effects of radiation to appear.

What they found was heartening, at least for the animals that got the Protectan: 70 percent of monkeys injected with the drug survived, compared with only 20 percent of controls. Those in the experimental group who lived also showed significantly less damage to their gastrointestinal tracts.

Fonstein expects the results to translate well from monkeys to humans, as they respond to radiation similarly, with people perhaps a bit more sensitive to radiation, but only on the order of around half a Grey or so.

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