What? Another "radiation protection drug?"
I believe that our experiences at Chernobyl was not immunsuppression, by what is loosely termed the "GI syndrome." Pallative care and anitbiotics have been used successful to treat doses of less than 6 Gy, so I do not think this drug will offer much to our treatment plans. Of course, since the non-human primate study involved non-treatment of control subjects, their drug was very successful. I would equate this to not treating car accident victims to see if they recover on their own.
If they are looking for humans who receive high doses of radiation, they could always evaluate the response of patients undergoing radiation therapy for cancer. I am sure that is what the makers of the rival durg Neupogen did.
Sorry for the rant, but this commercialism driven by out fear of radiation, i.e., nuclear attack, does nothing for our preparedness. To say that the drug will augement the use of KI preys on the publics fears and ignorance.
joseph.greco@kodak.com wrote:
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 th! e 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 T! hreats
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 Ha! ematology, 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
cand! idate 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 ap! proximately $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
pur! chasing 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.
...