Well actually it's an injection and it has to be given within 4 hours after exposure. But they (the drug company and U.S. Gov.) say it holds promise... link below Dxxxxxxx
[img]http://www.holliseden.com/graphics/cont ... ne.jpg[img]
Hollis-Eden’s lead drug candidate, NEUMUNE™ (HE2100), is being developed for the treatment of Acute Radiation Syndrome, or ARS, a life threatening condition resulting from exposure to high levels of radiation. In ARS, radiation damages production of major blood elements produced by the bone marrow – neutrophils, or white blood cells that protect against opportunistic infections, and platelets, key clotting elements that protect against bleeding episodes. Severe depletion of these blood elements can lead to conditions known as neutropenia (low neutrophil counts) and thrombocytopenia (low platelet counts). Either of these conditions can lead to death in the first 30 to 60 days following radiation exposure. If an individual can survive this initial period of insult, the bone marrow will generally return to normal production of these critical blood cell components.
There is an urgent need today for a practical ARS therapy that can be used on a widespread basis in the event of the very real possibility of terrorists exploding a nuclear or radiological device in one or more U.S. cities. Such an attack is the gravest threat we face as a nation today. A number of terrorist experts and national leaders have stated that such an attack, either through the use of a nuclear weapon or a “dirty bomb” (a combination of a conventional explosive and nuclear material), or through an attack on a nuclear power plant or waste site, is not a matter of if, but when.
Hollis-Eden is co-developing NEUMUNE with the Armed Forces Radiobiology Research Institute (AFRRI) — an agency within the U.S. Department of Defense and a leader in studying the short- and long-term effects of radiation injury. After screening thousands of compounds in an effort to find a radioprotectant suitable for widespread use, AFRRI selected NEUMUNE as its leading candidate for radioprotection based in part on its striking efficacy in earlier preclinical models conducted in mice. These studies showed that up to 100% of animals treated with NEUMUNE prior to being exposed to radiation survived versus up to 100% mortality in the animal group receiving placebo.
The Company is developing NEUMUNE under a new U.S. Food and Drug Administration (FDA) rule, under which marketing approval may be gained based on the demonstration of safety in humans and efficacy in relevant animal species when it would be unethical to expose humans to life-threatening pathogens or events, such as radiation, in an effort to determine clinical efficacy.
To date, Hollis-Eden has conducted studies involving more than 200 non-human primates, demonstrating that NEUMUNE has significant activity over a range of radiation exposures in maintaining neutrophils and platelets. These studies also suggest NEUMUNE can provide a survival benefit versus placebo-treated animals in models of high-dose radiation exposure.
Moderate-dose Non-human Primate Radiation Studies
In moderate-dose radiation studies in non-human primates, more than 140 animals have been studied to date with NEUMUNE. In these studies, activity has been shown at a range of doses and dosing schedules. When a 15 mg/kg dose of NEUMUNE was given IM once per day for five days, animals experienced 2 to 3 days of severe neutropenia versus 12 to 13 days for animals not receiving NEUMUNE. In addition, NEUMUNE treated animals experienced 2 to 3 days of severe thrombocytopenia versus 11 to 13 days for animals not receiving NEUMUNE. Both of these findings are statistically significant.
NEUMUNE Demonstrates Reduction in Days of Severe Neutropenia in Non-human Primates Exposed to Moderate-dose Radiation
NEUMUNE Demonstrates Reduction in Days of Thrombocytopenia in Non-human Primates Exposed to Moderate-dose Radiation
Survival Studies in Non-human Primates
In a proprietary high dose radiation survival model developed by Hollis-Eden, four pilot studies have been reported on to date. The results include data from a total of 80 animals, including 40 control animals receiving either no NEUMUNE treatment or placebo and 40 animals receiving one of three different dose levels of NEUMUNE. A total of 32.5% of the control animals (13/40) failed to survive this radiation exposure compared to 12.5% in the pooled treatment groups (5/40). A meta analysis of the survival difference between NEUMUNE treatment and control groups from these pilot studies already approaches statistical significance (p=0.059 using Fisher’s Exact Test). Consistent with previous studies, there were beneficial effects seen on both neutrophils and platelets in these experiments.
NEUMUNE Studies Indicate Survival Benefit in Non-human Primates Exposed to High-dose Radiation
Radiation survival data
NEUMUNE Demonstrates Reduction in Days of Severe Febrile Neutropenia* in Non-human Primates Exposed to High-dose Radiation
NEUMUNE Demonstrates Reduction in Days of Very Severe Thrombocytopenia* in Non-human Primates Exposed to High-dose Radiation
In 2005 Hollis-Eden initiated human clinical trials with NEUMUNE. The initial studies are expected to help establish the safety of NEUMUNE in humans and to help determine the concentration of the compound that can be achieved in human blood. This information can then be used in selecting the final dose for the pivotal efficacy study in non-human primates and the larger human safety study that will be required.
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