Bill, time to revisit HEPH ? seems they are going to save the world. In this mania it probably can run to the low 20's--
Friday December 7, 1:12 pm Eastern Time
Pentagon presses speedy radiation drug approval
By Jim Wolf
WASHINGTON, Dec 7 (Reuters) - The U.S. Defense Department, fearing new forms of terrorism, hopes to win regulatory approval within three or four years of a novel drug designed to help protect people from radiation, a key researcher said Friday.
Rights to the lead candidate drug --a naturally occurring steroid hormone known as 5-androstenediol -- are owned by Hollis-Eden Pharmaceuticals Inc. (NasdaqNM:HEPH - news) of San Diego, California.
``I would say probably (in) three or four years, I would hope under ideal conditions ... to have this compound approved for human use,'' by the Food and Drug Administration, said Dr. Thomas Seed, leader for radiation casualty management at the Armed Forces Radiobiology Research Institute in Bethesda, Maryland.
The institute is spearheading a drive to protect U.S. military personnel against ionizing radiation injuries and risks amid heightened, post-Sept. 11 fears of terrorist attacks in the United States.
Ionizing radiation is the deep-penetrating type from nuclear or radiological blasts that can break bonds in cells and destroy the immune system, leaving victims vulnerable to potentially fatal infections. Other forms, such as ultraviolet, cause other damage.
The Hollis-Eden drug is aimed mainly at preventing death in the short term by restoring infection-fighting immune system cells.
Such a drug would also be useful for civilians, including nuclear reactor workers and people responding to an accident at a nuclear power plant, Seed said.
Shares in Hollis-Eden rose on Friday after the New York Times reported that one of its compounds was the military's leading candidate to give to military personnel in advance of possible radiation exposure.
In midday trading, the shares rose $1.90 to $12.25, up 18 percent. Stock in the company, which also develops treatments for infectious diseases and immune system disorders, has ranged from $2.12 to $11.63 in the last 52 weeks.
Seed, in a telephone interview with Reuters, said the Hollis-Eden drug so far had been tested only on small animals such as mice and rats.
Depending on the dosage, injections have protected up to 100 percent of mice from a level of radiation that killed all the mice in the control group -- ``no question about that,'' he said.
Since it would be unethical to expose people to large doses of radiation to test the drug's effectiveness, Seed said he hoped the FDA would approve it under a proposed new rule that would weight more heavily preclinical tests on primates such as monkeys.
He said he hoped to wind up preclinical trials within a year or two. Next would come so-called Phase 1 trials on human volunteers to gauge dosage safety and how the drug distributes in the body and is metabolized.
Dan Burgess, a Hollis-Eden spokesman, said the drug might be available sooner in light of what he called the pressing need for novel radiation protectants.
``We think there may be opportunities to shorten these timelines,'' he said, citing possible parallel testing rather than consecutive steps.
The compound's properties as a potential radio protectant were first identified by Dr. Roger Loria of Virginia Commonwealth University in Richmond, Virginia, Burgess said.
Separately, the Nuclear Regulatory Commission said it had earmarked $800,000 to buy millions of potassium iodide pills as supplemental protection against thyroid cancer in those exposed to any serious incident at a nuclear power plant.
``We will pay for it and negotiate with manufacturers,'' once the FDA has decided on proper dosage levels, said Susan Gagner, a commission spokeswoman. The pills would be stockpiled by the 40 states that have either active nuclear power plants or ones being cleaned up after permanent shutdowns, she said.
They would supplement sheltering and evacuating people if there were a severe nuclear incident, Gagner said. |
