Ex-Rad, the U.S. Military's Radiation Wonder Drug

The immense loss of life and absolute devastation caused by last week’s earthquake and tsunami is heartbreaking – and serve as the culprits in this unimaginable tragedy. The tension, felt by its citizens and far beyond the country’s borders, centers most immediately on what happens next at the Fukushima Daiichi nuclear facility.

Reports of radioactive contamination and a potential meltdown at the complex have many Americans wondering how prepared our own government would be in the event something similar occurred here. More specifically, could the the health of residents living near a severely damaged nuclear reactor in the U.S. be ensured?

Thanks to the advanced work of the men and women who develop our nation’s military medicine, the answer is yes – but only if the government now takes the necessary steps.

In what has to be one of the greatest accomplishments in the history of military medicine, the U. S. military has developed a radiation protection drug known as Ex-Rad that can give protection through DNA repair against otherwise lethal dosages of radiation. Ex-Rad, which is administered as an injection or orally, can be given either before or after exposure. While Ex-Rad officials are continuing to work with the FDA, it has successfully cleared two clinical studies showing it is safe.

Ex-Rad’s life-saving utility isn’t limited to countering radiation exposure near a compromised nuclear facility. From potentially enabling cancer patients to withstand greater levels of radiation to protecting soldiers deployed into radioactive “hot zones,” this drug delivers critical help and hope.

During most of the last decade, U.S. military scientists at the Armed Forces Radiobiology Research Institute have worked with some of the best scientists in the American private sector to develop this radiation protection..."

"Reads like a stock toot. No facts, just hype."

I've looked, but have been unable to find a listing for Onconova Therapeutics, which appears to be the main private sector company involved.

Some info, from 9/27/2010:

Onconova Therapeutics presents new data demonstrating radioprotection by Ex-RAD at RRS annual meeting Orally administered Ex-RAD (ON 01210.Na) is radioprotective in pre-exposure prophylaxis and post-exposure mitigation animal models

Newtown, PA, September 27, 2010 – Onconova Therapeutics, Inc. is presenting new data in five posters and an oral presentation this week summarizing several studies with the company's radioprotectant Ex-RAD® at the 56th Annual Meeting of the Radiation Research Society (RRS), September 25-29 in Maui, Hawaii. In vivo studies show that Ex-RAD®, upon oral administration, produced a significant increase in survival versus placebo-treated groups in mice exposed to lethal whole body irradiation (WBI), for both prophylactic pre-treatment and mitigation post-treatment. Ex-RAD® is the only known oral radioprotectant that has shown such activity in animal model systems.

Collectively, these presentations demonstrate the ability of Ex-RAD® to provide radioprotective benefit by injection and oral delivery, an in-depth understanding of the kinetics and metabolism of Ex-RAD®, and radioprotective benefit to human bone marrow, as well as the gastrointestinal and hematopoietic systems in mice.

Onconova, a biopharmaceutical company developing novel chemical entities to treat cancer and protect normal cells, is developing Ex-RAD®, a novel radioprotectant with potential utility in bio-defense or bio-terrorism, which could prove useful as a prophylactic agent for first-responder protection from the harmful effects of radiation from nuclear accidents or weapons of mass destruction (WMD).

These presentations result from an on-going Onconova collaboration among investigators at a number of institutions: AFRRI, (The Armed Forces Radiobiology Research Institute) a part of the Uniformed Services University of the Health Sciences (USUHS); Georgetown University, Department of Biochemistry and Molecular & Cellular Biology; Long Island University, Arnold & Marie Schwartz College of Pharmacy; and the Department of Oncological Sciences, Mt. Sinai School of Medicine.

Summary of Oral Ex-RAD® Findings

The results from a prophylactic radioprotection study in mice demonstrated that Ex-RAD® dosed orally or by injection prior to lethal whole body irradiation (WBI) produced significant enhancement in survival for both Ex-RAD® treated groups versus placebo.

Results from the radiomitigation experiment (where the drug is administered after exposure to lethal radiation), using both injection and oral methods of delivery demonstrated that Ex-RAD® treated animals had comparably high rates of survival in both groups.

Hence, oral Ex-RAD® was found to be effective in both prophylactic pre-treatment and mitigation post-treatment settings.

"Years of collaborative work are resulting in great progress with Ex-RAD® in the laboratory and the clinic and Ex-RAD® is the focus of several posters and a key presentation within the RSS scientific and educational track," said Manoj Maniar, PhD, Senior Vice President for Product Development of Onconova. "We are very excited to see the acceleration and new developments within radioprotection, specifically in oral prophylaxis and treatment. Ex-RAD® holds a unique position among developing products with the potential to benefit people exposed to whole body radiation."

Onconova oral presentation and poster sessions on Ex-RAD® at the Radiation Research Society meeting:"

Continued: http://www.eurekalert.org/pub_releases/2010-09/poc-otp092710.php

More, from 2/17/2009:

"Radiation protection by a new chemical entity, Ex-Rad: efficacy and mechanisms.

Ghosh SP, Perkins MW, Hieber K, Kulkarni S, Kao TC, Reddy EP, Reddy MV, Maniar M, Seed T, Kumar KS.

Armed Forces Radiobiology Research Institute, USUHS, Bethesda, Maryland 20889-5603, USA. ghosh@afrri.usuhs.mil Abstract

Ex-Rad is among a series of small molecule kinase inhibitors developed for modifying cell cycle distribution patterns in cancer cells subjected to radiation therapy, and it has been identified as a potential candidate for radiation protection studies. We have investigated its radioprotective efficacy using mouse and in vitro models. Thirty-day survival studies with C3H/HeN male mice revealed 88% survival when 500 mg/kg of Ex-Rad was injected subcutaneously 24 h and 15 min before gamma irradiation with 8.0 Gy. To understand Ex-Rad's mechanism of action, we also studied its radioprotective efficacy in lung fibroblast (HFL-1), skin fibroblast (AG1522) and human umbilical vein endothelial cells (HUVECs). Colony-forming assays indicated that Ex-Rad protected cells from radiation damage after exposure to (60)Co gamma radiation. A study using single-cell gel electrophoresis (SCGE; also known as the alkaline comet assay) showed that Ex-Rad protected cells from radiation-induced DNA damage. Western blot analyses indicated that the radiation protection provided by Ex-Rad resulted in reduced levels of pro-apoptosis proteins such as p53 as well as its downstream regulators p21, Bax, c-Abl and p73, indicating that Ex-Rad could rescue cells from ionizing radiation-induced p53-dependent apoptosis. In conclusion, it appears that Ex-Rad's radioprotective mechanisms involve prevention of p53-dependent and independent radiation-induced apoptosis.

PMID: 19267542 [PubMed - indexed for MEDLINE] "

http://www.ncbi.nlm.nih.gov/pubmed/19267542

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