Nuclear bomb radiation drug shows promise - company

[joseph.greco@kodak.com]

Nuclear bomb radiation drug shows promise - company



http://www.planetark.org/dailynewsstory.cfm/newsid/20403/story.htm



USA: April 8, 2003



NEW YORK - Hollis-Eden Pharmaceuticals Inc. yesterday reported promising

results from a drug designed to protect against radiation caused by a

nuclear bomb.



The drug, currently called HE2100, would protect most of a population

outside the immediate ring of a nuclear attack from death or

hospitalization, the company said. Hollis-Eden has thus far not

disclosed other potential applications for HE2100.



The drug cannot be tested in humans because it would be too dangerous to

expose them to radiation. But it appears in an early trial to reduce the

loss of infection-fighting cells in non-human primates.



Death by radiation is usually caused by a depletion of white blood

cells, which protect the body against infection. HE2100 speeds up the

body's ability to produce new white blood cells to help replace those

that are destroyed.



Death can also be caused by bleeding, as radiation also destroys the

ability of blood clots to form. HE2100 helps the blood form new clots,

the company said.



Hollis-Eden, based in San Diego, California, released its data at the

Annual Scientific Meeting of the British Society for Hematology in

Glasgow, Scotland.



The results must now be confirmed in a larger, late-stage trial. If they

are replicated and the drug is approved by the U.S. Food and Drug

Administration, it could be available by 2004.

...



REUTERS NEWS SERVICE



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http://www.holliseden.com/press2.cfm?press_id=120



Hollis-Eden Pharmaceuticals Announces HE2100 Provides Significant

Protection From Radiation In Primate Study Investigational Drug Being

Developed as Countermeasure for Nuclear Threats



San Diego, California -- April 7, 2003 --Hollis-Eden Pharmaceuticals,

Inc. (NASDAQ:HEPH) today announced positive preliminary results from a

study in non-human primates that demonstrated its immune regulating

hormone HE2100 is providing significant protection from the acute life

threatening effects of whole body radiation exposure. High levels of

whole body radiation damages a person's bone marrow resulting in

neutropenia ? a severe loss of neutrophils, or key white blood cells ?

which results in a high risk of infection, hospitalization and potential

death. Preliminary results from the Company's pilot study indicate when

HE2100 is given 24 hrs before or 2 to 4 hrs after radiation exposure, a

statistically significant reduction in the occurrence of severe

neutropenia is observed as compared to control animals not receiving

drug. The data were presented today at the 43rd Annual Scientific

Meeting of the British Society For Haematology, being held April 7?9,

2003 in Glasgow, Scotland.



Under a new U.S. Food and Drug Administration (FDA) rule, where it would

be unethical to expose healthy humans to radiation in an effort to

determine clinical efficacy, marketing approval as a drug to provide

protection from acute radiation injury may be gained solely on the

demonstration of safety in humans and efficacy in relevant animal

species. Hollis-Eden believes that the non-human primate is the most

relevant animal species to demonstrate efficacy that would correlate in

humans. This initial pilot study is the first of several to be conducted

to determine the optimal dosing regimen. Following these pilot studies,

Hollis-Eden plans to conduct a pivotal efficacy study in non-human

primates, which the Company believes is comparable to a Phase III

clinical trial to demonstrate efficacy of HE2100 under the new FDA rule.

The Company expects to apply for approval of HE2100 for radioprotection

in 2004.



In the pilot study, animals were given only one dose of HE2100 24 hours

prior to being exposed to 400cGy of radiation, and other animals were

given daily doses of HE2100 beginning 2 to 4 hours after radiation

exposure. A control group of animals received no medicine. By day 8

after radiation exposure, the majority of the control animals

experienced severe neutropenia and were administered preventative

antibiotic therapy. Three weeks after radiation, the average percentage

of days of severe neutropenia (<500 neutrophils/uL) was 47% for the

control group versus 17% for a group receiving a single dose of HE2100

before radiation exposure and 11% for a group of animals treated with

HE2100 after radiation exposure. This represents a 4-fold decrease in

the percentage of days the animals in the post-radiation treatment group

were at high risk for infection ? the leading cause of mortality

following whole body radiation.



"These data mean that in a scenario of a nuclear event, such as a dirty

bomb or nuclear accident, where tens of thousands of people are

potentially exposed to high levels of radiation, HE2100 may offer a

cost-effective treatment that could significantly improve the chance of

survival and reduce the necessity of hospitalization at a time when

medical facilities would be overwhelmed," said Dwight R. Stickney, M.D.,

Radiation Oncologist and Medical Director, Hollis-Eden Pharmaceuticals,

Inc. "The data are still being developed from this pilot study and there

is more work to be done to optimize the administration parameters;

however, we are very excited by the significant protection that was

afforded the animals from the toxicity of radiation in a model relevant

to man."



Hollis-Eden is co-developing HE2100 with an agency within the U.S.

Department of Defense, where HE2100 has emerged as the agency's leading

candidate for radioprotection. Results of several previous studies

conducted in mice have been published in the International Journal of

Immunopharmacology and in Radiation Research. These studies showed that

HE2100, when given to animals shortly before or shortly after exposure

to lethal doses of radiation, provided significant survival advantages

in HE2100-treated animals versus placebo-treated animals. In that study,

100% of animals treated with HE2100 24 hours prior to being exposed to

900cGy of radiation survived versus 100% mortality in the animal group

receiving no drug. Investigators conducting the study attributed the

survival advantage to HE2100's ability to increase a number of cell

types associated with immune protection, including neutrophils and

platelets.



The leading drug currently marketed for neutropenia is Amgen's Neupogen,

which is used in the setting of chemotherapy-induced neutropenia.

Neupogen costs the patient approximately $2,500 per treatment regimen

and generates annual revenue of approximately $1.5 billion. Neupogen

received FDA approval on the basis of the reduction of infections by

shortening the time of neutropenia in cancer patients undergoing

chemotherapy.



There is an urgent, unmet medical need for a safe and practical

countermeasure for the significant risk of neutropenia resulting from

high levels of radiation exposure. The only drug that is currently

available for stockpiling in the event of radiation injury is potassium

iodide. However, potassium iodide is only effective against the

long-term risk of thyroid cancer, and does not protect the body from the

acute effects on the bone marrow, which can lead to rapid fatalities.

Despite this limitation, potassium iodide has been stockpiled broadly

for years in Europe and Japan for civilians living within close

proximity of nuclear power plants, and the U.S. has recently begun

purchasing millions of doses of the drug for similar uses in this

country. In addition, the Strategic National Stockpile, a program of the

Department of Homeland Security, has already stockpiled enough drugs to

treat 100 million people exposed to plague, 50 million people exposed to

tularemia and 12 million people exposed to anthrax. The agency claims it

can deliver the drugs anywhere in the country in 12 hours or less. Given

that HE2100 may be useful in protecting against the immediate life

threatening effects of radiation, the Company believes there may be

strong interest by government agencies to adopt a similar stockpiling

strategy if HE2100 is successfully developed.



...



Hollis-Eden Pharmaceuticals, Inc. is a development-stage pharmaceutical

company based in San Diego, California, working to become the world

leader in the development of a new class of investigational drugs known

as Immune Regulating Hormones (IRHs).





_____________________________



Joseph M. Greco, CHP

Radiation/Laser Safety Officer

Eastman Kodak Company

Rochester NY 14652-6261

voice:  585-588-3324

fax:       585-588-0825

email:   joseph.greco@kodak.com

motto:  "illegitimi non carborundum"







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