SCOTTSDALE, Ariz. -- IR BioSciences Holdings, Inc. (IRBO), owner of biotechnology research and development company ImmuneRegen BioSciences, Inc., has completed its sixth study of the company’s proprietary substance, Radilex™, on exposure to fatal doses of radiation. This study was requested by the Department of Counter-Terrorism of the U.S. Food and Drug Administration to determine the most effective method of administering Radilex.
The study results found aerosol delivery of Radilex to be superior over direct muscle injection in preventing acute radiation sickness (ARS) post lethal exposure (PLE). ImmuneRegen also found that Radilex may have efficacy in reducing the negative effects of radiation treatment on cancer patients, such as hair loss, wound healing difficulties, and immune system suppression.
“The results of this study have strengthened our confidence in utilizing an aerosol method of delivery and brought us yet another step closer to FDA approval,” says Michael Wilhelm, CEO of ImmuneRegen BioSciences, Inc. “It has also put us further ahead of the pack in the pursuit of developing a treatment for ARS. All the other research available shows comparable therapies are being tested at sub-lethal levels of radiation exposure. After completing six rounds of testing with lethal dosages of radiation, we’re confident our treatment can save lives and better prepare our country for terrorist attacks.”
Conducting the study at the University of Arizona, Dr. Mark Witten, PhD, co-founder and chief scientific officer of ImmuneRegen BioSciences, Inc., found aerosol to be the superior methodology over direct muscle injection. Past aerosol tests showed up to a 50 percent survival rate post lethal exposure (PLE) to radiation.
While further study is needed, Dr. Witten believes this finding may be due to a difference of neurokinin receptors in the lungs to those in skeletal muscle. Past research shows the predominant neurokinin receptor in rat skeletal muscle was demonstrated to be the neurokinin-2 receptor. The predominant neurokinin receptor in the lungs is the neurokinin-1 receptor. Radilex is known to be a neurokinin-1 receptor agonist.
In study number six, Witten and his team made a new discovery that could lead to an additional possible application for Radilex. During the testing, some of the subjects developed open wounds from natural causes. During the 60-day period, during which half of the subjects were injected with the Radilex, those in the control groups remained injured and those that were treated healed.
“What’s exciting about these results is that we found something we weren’t looking for. We already know that Radilex has the ability to treat acute radiation sickness and that it can greatly increase a person’s chance of survival after a nuclear attack. In this study, we discovered a wound healing property that no one even thought to look for,” says Dr. Witten. “This find has sparked a need to study all methods of delivery further. At first glance, we think Radilex can be developed into a treatment that would allow cancer patients to undergo radiation treatment without the debilitating side effects which are so common.”
The test subjects consisted of 300 mice separated into three groups of 100. Each group was exposed to different levels of radiation -- 7 gray, 8 gray (fatal dose) and 9 gray (fatal dose) -- and consisted of 25 male subjects treated with Radilex, 25 female subjects treated with Radilex, and the corresponding control subjects. Each mouse was given a single dose of radiation, then all non-control mice received a dose of Radilex by direct muscle injection on a daily basis for 60 consecutive days.
Source: ImmuneRegen BioSciences, Inc.