Ex-RAD® “Wonder” Radiation Drug for Protection from Radiation Injury

Clinical Development Stage

 

Ex-RAD® (ON 01210.Na) is in Phase I clinical testing as a radiation protection agent. Radioactive contamination and injury from ionizing radiation can arise from accidents involving nuclear reactors and industrial or medical sources. Recent events have highlighted the potential for non-accidental radiation injury as a result of malicious, criminal, or terrorist actions. Pharmaceutical agents that can “prevent and repair” cellular radiation damage can help in mitigating radiation injury.

Using a cell biology-based screening approach, we identified Ex-RAD® that provided protection from lethal ionizing radiation. Ex-RAD® development, which is initially focused on military applications, is being supported by a funded collaboration with the U.S. Department of Defense (DoD). Ex RAD® is being developed according to the FDA’s Animal Rule – Marketing approval for new countermeasures for which human efficacy studies are not feasible or ethical would be based on animal studies and Phase I safety data in healthy volunteers, without Phase II or Phase III clinical studies.

 

EFFICACY STUDIES

Under the Animal Rule, the FDA requires adequate, well-controlled efficacy studies in animal models that establish that the drug product is reasonably likely to produce clinical benefit in humans. In multiple cell-based and whole animal models, Ex-RAD® has demonstrated protection from radiation injury when administered either before or after radiation exposure. Studies on efficacy have been conducted in collaboration with scientists at the DoD’s Armed Forces Radiobiology Research Institute (AFRRI). Results have recently been published (S.P. Ghosh, et al. “Radiation protection by a new chemical entity, Ex-RAD®: efficacy and mechanisms.” Radiat Res 171: 173-179, 2009).
UNIQUE MODE OF ACTION

Unlike most radiation protectors, Ex-RAD® is not a free-radical scavenger, chelator, nor cell cycle arrestor. Available data suggest that Ex-RAD® accesses a novel mechanism for radiation protection involving intracellular signaling, damage sensing, and DNA repair pathways. Ex-RAD® treated cells sustain less DNA damage upon exposure to irradiation. Results of the DNA comet assay (adapted from Ghosh et al., 2009) are shown in the accompanying figure.
Image Analysis of Irradiated HFL-1 Cells

Irradiated cells

In cells responding to radiation injury, Ex-RAD® significantly reduces levels of p53, p21, bax, c-abl and p73 proteins, which are key players in the DNA damage cascade. These effects likely cause a halt in cell death pathways and lead to increased recovery and survival of irradiated cells.

The novel mechanisms of action and virtual lack of side effects at effective dosage suggest that Ex-RAD® could be useful both as a prophylactic agent and as a therapeutic for mitigation.
PHASE I CLINICAL TRIALS

Onconova has completed two Phase I clinical studies of Ex-RAD® in healthy volunteer subjects. Following increasing single or double doses by subcutaneous administration, the drug was well-absorbed, reaching maximal blood levels in about two hours, with no evidence of systemic side effects and good local tolerance. . Ex-RAD® is formulated for injection and can be stored and transported without refrigeration. An auto-injection device is under development for field use. Development of an oral formulation for specialized and broader use is ongoing

Source: Onconova.com

Views: 92

Comment

You need to be a member of 12160 Social Network to add comments!

Join 12160 Social Network

"Destroying the New World Order"

TOP CONTENT THIS WEEK

THANK YOU FOR SUPPORTING THE SITE!

mobile page

12160.info/m

12160 Administrators

 

Latest Activity

Doc Vega posted a blog post

What US Scientist unwittingly helped the Nazis devise the V-2 Missile?

  In the early 1920’s and leading up to World War II German technology outpaces the peace time…See More
5 hours ago
tjdavis favorited Sandy's video
21 hours ago
tjdavis posted a photo
22 hours ago
Christopher Walker is now a member of 12160 Social Network
yesterday
tjdavis posted videos
yesterday
Burbia commented on tjdavis's photo
Thumbnail

Reflection

"Let's see if this goes past indictment."
Saturday
Doc Vega commented on Doc Vega's blog post Something Watches From Out there in the Wilderness
"cheeki kea That's very interesting history. So many things about history that go ignored or…"
Saturday
Burbia commented on Burbia's video
Saturday
Burbia posted a video

Programmed To Kill/Satanic Cover-Up Part 433 (The Charlie Kirk Conspiracy Show)

https://www.programmedtokill.net/projects---- DISCLAIMER! ----Copyright Disclaimer Under Section 107 of the Copyright Act 1976, allowance is made for "fair u...
Saturday
cheeki kea commented on cheeki kea's photo
Thumbnail

American werewolf- 2018

"Yip I've looked again and this is what the creature looks like, even has stripes just like…"
Saturday
cheeki kea commented on cheeki kea's photo
Thumbnail

American werewolf- 2018

"The mystery continues I guess. ( reminds me of something out of the under world )"
Saturday
cheeki kea posted a photo
Saturday
cheeki kea commented on Doc Vega's blog post Something Watches From Out there in the Wilderness
"Another fine story Doc V. I think it's Dogman the werewolf out there roaming around in high…"
Saturday
Doc Vega posted blog posts
Saturday
Doc Vega commented on Doc Vega's blog post What Four UFO Whistle Blowers All Suffered in Common?
"Less Prone Thanks for you comment Buddy! Dabbling in government kept secrets can cost you dearly. I…"
Saturday
Burbia posted a blog post

Sebastion Piñera and 5G

 Sebastion Piñera “The start of the bidding process for the 5G network. Let’s listen to the threats…See More
Saturday
tjdavis posted a photo
Friday
Doc Vega posted a blog post
Thursday
Less Prone left a comment for Tammy
"Welcome"
Thursday
tjdavis posted a video

Mike Benz: DARPA & USAID are Weaponizing Music to Control Human Behavior

Watch every episode ad-free & uncensored on Patreon: https://patreon.com/dannyjonesMike Benz is a former State Department official and current Executive Dire...
Thursday

© 2025   Created by truth.   Powered by

Badges  |  Report an Issue  |  Terms of Service

content and site copyright 12160.info 2007-2019 - all rights reserved. unless otherwise noted