Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.

Reuters NewMedia - December 3, 2004
Deena Beasley

"If a major city were hit with a nuclear device, it has been estimated that close to a million people would be exposed to the radiation," said Richard Hollis, chief executive of the San Diego-based company.

Radiation damages the bone marrow, which produces infection-fighting white blood cells, platelets that help blood to clot and oxygen-carrying red blood cells. The result is lethal infections and hemorrhaging.

Current treatments, such as infusions of platelets and antibody-based drugs, cost thousands of dollars and require hospitalization. "That just isn't practical in an emergency setting," Hollis said.

Other drugs, such as potassium iodide, are designed only to protect against the risk of thyroid cancer years after a nuclear detonation or accident.

The company's experimental drug, called Neumune, offers an alternative that seems to be effective in healing the disruption to blood cell formation caused by radiation injury with no notable toxicity, said Dr. Terry Pellmar, scientific director at the Armed Forces Radiobiology Research Institute.

Hollis-Eden is meeting with U.S. regulators this month to iron out the details of a final study in animals of Neumune. The injected drug's safety must then be tested in humans, although trial patients will obviously not be subjected to radiation poisoning. The company said it expects to finish the trials next year.

Neumune is a naturally occurring hormone that protects components of bone marrow, enabling the body to recuperate over several weeks after radiation exposure, said Dr. Dwight Stickney, the company's vice president, medical affairs.

Hollis-Eden was founded in 1994 to commercialize patented hormones for treating immune disorders such as HIV. But those efforts were put on the back burner following actions by the World Health Organization and others to buy and distribute cheap, generic AIDS drugs in poor countries.

"We decided to change course because there's a better market opportunity," Hollis said.

The company last month responded to a request from the U.S. Department of Health and Human Services for information about drugs to treat acute radiation syndrome. Under the "BioShield" law enacted in July, $5.6 billion over 10 years was earmarked for private sector research and government stockpiling of drugs and vaccines that otherwise might not find a commercial niche.

Hollis said the company plans to pursue regulatory approval of Neumune regardless of whether it is awarded a government contract. "We believe there is a market ... for first responders like police forces and possibly civilians. There are also foreign markets," the CEO said.

In a small study being made public in San Diego this weekend at a meeting of the American Society of Hematology, 90 percent of monkeys subjected to radiation and treated with Neumune survived compared to 55 percent of the animals that received no treatment or placebo.

The drug is less effective at very high radiation levels.

Hollis said a treatment course of Neumune -- five daily injections -- would likely be priced at around $100, assuming the United States decides to stockpile millions of doses.

If sales are lower, the price would be higher, he said.

Late Thursday, shares of Hollis-Eden, which posted a loss of $16.4 million in the first nine months of this year, were up 8.2 percent at $11.13 on Nasdaq.

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