Tuesday, August 20, 2019

Israeli cell therapy company offers solution after failed Russian experiment

Radiation poisoning, known in the medical world as acute radiation syndrome or ARS, is a grave illness that often leads to death.

BY 
 , August 19, 2019, The Jerusalem Post 
https://www.jpost.com/Israel-News/Israeli-cell-therapy-company-offers-solution-after-failed-Russian-experiment-599089


Biologists work in a laboratory at Pluristem Theraputics in Haifa. (photo credit: REUTERS)

On Sunday, Block 4 of Russia’s Beloyarsk nuclear power station in the Urals mountains was switched off following a “false” response by the safety system, according to a report by a subsidiary of state nuclear corporation, Rosatom. The plant was opened in 1964.

This event followed last week’s, when Rosatom carried out a mysterious test close to inhabited areas, which killed five people and caused a spike in radiation, with radiation levels reaching as much as 16 times higher than they should be.

Serious nuclear accidents have been few and far between – seven since 1957 – but their stories send chills down your spine. That’s because radiation poisoning, known in the medical world as acute radiation syndrome or ARS, is a grave illness that often leads to death, usually due to a decrease in blood cells. 

An Israeli company, however, told The Jerusalem Post that it has a remedy. 

A drug invented and being developed by Haifa’s Pluristem Technologiesmay revolutionize the treatment of ARS and could “make the difference between a catastrophic event and one that can be maintained,” said Pluristem co-CEO Yaky Yanay.

Pluristem’s PLX-R18, a simple shot of placenta blood cell serum injected into the thigh, induces a victim’s body to create new blood cells, repopulating his or her blood system. 

When someone is exposed to radiation, it attacks all three blood lineages – white and red blood cells and platelets – putting the individual at risk. Low white blood cell count suppresses or weakens the immune system, making an individual vulnerable to infection. Red blood cells carry oxygen to the body, so people cannot live without them. Platelets are responsible for coagulation, preventing internal bleeding.

“We know with our compound that in the event of a nuclear disaster, we could reduce the number of fatalities by thousands,” said Arik Eisenkraft, former head of the Chemical, Biological, Radio-Nuclear (CBRN) Medicine branch of the Israeli Ministry of Defense, who currently serves as Pluristem’s director of homeland defense projects.

Pluristem’s cells are grown using the company’s 3-D micro-environmental technology. An “off-the-shelf” product, PLX-R18 doesn’t require the matching of tissues between the donor and recipient, it can be administered instantly in the field in the event of a multiple-casualty radiation attack.

Further, PLX-R18 can be administered quickly and efficiently through an intramuscular shot, and can be given to someone whether he or she has been exposed or not, according to clinical trials. 

Eisenkraft told the Post that when one looks at the recent Russian explosion – or any similar event – there are two types of people who would need PLX-R18: victims and first responders.

“In the case of victims exposed to radiation, the most obvious thing is to provide them with therapy,” Eisenkraft said. “But there is also another group of people that would benefit: Police, emergency personnel, firefighters and medical providers. If they get this treatment, they can feel more secure going in and helping to save the lives of those who were exposed.”

PLX-R18 cell therapy showed positive results from a series of studies conducted of the product by the US Department of Defense’s (DoD) Armed Forces Radiobiology Research Institute at the Uniformed Services University of the Health Sciences. The studies were designed to evaluate PLX-R18 as a potential prophylactic countermeasure or vaccine against ARS when administered prior to radiation exposure.  

These animal studies demonstrated that PLX-R18, administered 24 hours before radiation exposure, and again 72 hours after exposure, resulted in a significant increase in survival rates, from 4% survival rate in the placebo group to 74% in the treated group. 

In addition, the data showed an increase in recovery of blood lineages and a favorable safety profile. 

PLX-R18 is now also being evaluated by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, as a treatment following radiation exposure with positive results. 

Further, preliminary studies show that PLX-R18 may provide effective in the treatment of exposure to other deadly agents, such as those found in chemical weapons.

Eisenkraft said that any country that operates using nuclear energy, has old nuclear plants, or is at risk for a nuclear attack must be prepared. 

“Governments are putting a lot of effort into hiding the exact scope of the problem,” he said. “Most nuclear reactors around the world are aged. There are several countries around the world in which the infrastructure is not at its best and these accidents are an imminent threat.”

He said that although he cannot predict when the next accident could occur, he said nuclear accidents and incidents can happen as a result of anything from climate change to conflict.  

“I can see what happened in Russia happening all over, in Europe, the United States and Israel,” Eisenkraft said.

Yanay said that Israel holds “the most aged nuclear facility in the world, which is not good news.

“Everyone talks about the North Korean or Iranian threat – the case of an attack or an act of terrorism,” he continued. “It is important for me that people know there will be a solution to contain such a catastrophic event.”

Yanay said that governments will be able purchase a supply of PLX-R18 and add it to their disaster recovery supplies. The product is stored in the freezer and takes minutes to thaw and administer. One placenta can produce more than 20,000 treatment doses.

He said that Pluristem is housing a store in its headquarters in case of a nuclear incident in Israel. The product is not yet FDA approved, but Eisenkraft said that once the company competes all of the FDA requirements, its manufacturing facility is already set up and prepared for mass production.

Already, the FDA cleared PLX-R18 as an “Investigational New Drug” (IND) in the treatment of ARS. The IND allows Pluristem to treat victims who may have been acutely exposed to high dose radiation due to nuclear attack or accident.

“The fact that we are now able to treat human casualties in the case of a nuclear event provides us with the ability to protect from severe health consequences, saving lives of population in need,” said Pluristem’s co-CEO Zami Aberman.

Yanay noted that the “18” in PLX-R18 stands for “chai,” life in English. 

“We need to make sure people stay alive after a radiation attack,” he said. 

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