March 11, 2017, marks the sixth anniversary of the Fukushima Daiichi nuclear disaster, but how geared up are the governments to face another disaster like that?
The damage caused to the health of the local population will be experienced by the people in many ways, which includes being prone to various forms of cancers caused by Acute Radiation Syndrome (ARS).
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The National Institutes of Health (NIH) has conducted advanced clinical trials of Pluristem's PLX-R18 cell therapy products that can be stockpiled by governments and easily administered to citizens following a nuclear disaster, with the aim of counteracting the impacts of ARS.
Pluristem is also working with Fukushima Medical University and Science Center to develop treatments for other ARS indications.
International Business Times, India exclusively interviewed Dr Arik Eisenkraft, Director of Homeland Defense Projects at Pluristem Therapeutics, a leading Israel-based developer of placental cell therapy products to know more.
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International Business Times, India: What are your thoughts regarding the prevailing health conditions of people?
Dr Eisenkraft: Relatively speaking, six years is too short a timeframe in which we can accurately assess the long-term health effects stemming from the exposure to radiation. Detrimental health effects could result from the initial, primary exposure immediately following a nuclear disaster, but could also result from ongoing, long-term exposure to a contaminated environment. We don't have the proper tools to measure field dosimetry, so in most cases, we can't assess the exact levels of radiation a person is exposed to during or immediately following an event. However, much effort is being invested in monitoring and understanding the environmental effects of exposure to radiation, with the aim of reducing both exposure and the related effects.
We are no longer talking about cases of Acute Radiation Syndrome (ARS), but looking for a possible rise in malignancies due to exposure to radiation or radioactive particles overtime, with a particular focus on thyroid cancer (which is the most common consequence of initial and/or long-term exposure to radiation). Moreover, stress reactions, namely clinical signs and symptoms related to post-traumatic stress disorder (PTSD) may have significant long-term effects on human behaviour.
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In developing our PLX-R18 products, our goal is to give governments the treatments they would need to help their citizens counteract the devastating effects of Acute Radiation Syndrome.
IBT: What made you come up with this idea and how many major organisations are contributing in this good cause?
Dr Eisenkraft: The goal of providing an efficient medical countermeasure to ARS is high on the agenda of both health and defence authorities around the world. This is regarded as a basic need governments should supply to their citizens. To date, there are still major treatment gaps, with only partially effective responses to bone marrow failure, the most life-threatening component of ARS, and practically no response to injuries occurring in other physiological systems, including the GI tract, lungs, neurovascular system and the skin. New innovation is still required in this critical field.
Based on our pre-clinical studies with PLX (placental-expanded) cells, we noticed they showed several highly unique characteristics and had positive effects on haematological related disorders. Soon after the Fukushima disaster, we decided to probe further and pursue the development of a dedicated treatment for ARS. Following a series of tests and studies, we were able to determine that our cells contribute to the recovery of all blood lineages including the white blood cells, red blood cells and platelets, and support the patient's hematopoietic system, which is a major part of ARS recovery. In addition, we investigated the use of PLX-R18 for the treatment of bone marrow failure and insufficient hematopoietic recovery following bone marrow transplant and we received US FDA clearance to initiate a clinical trial for the latter indication.
Fortunately, we were – and still are – supported by the US National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID), which is among the leading institutes in the United States investing efforts into finding countermeasures to ARS. Currently, the advanced-stage clinical trial of our treatment for ARS is being funded and conducted by the NIAID along with a number of other governmental agencies that are involved in the effort to help find a solution.
Though each organisation is focusing on different aspects of the challenge –some, for example, are focused on first responders and hospital staff —I am confident that the numerous initiatives and collaborations will yield immense benefits to all. It is important to remember that this cannot be achieved without strict regulations, which are aimed at ensuring the quality and safety of these medical countermeasures. That is why the FDA is deeply involved in the whole process, including defining the protocol of use, ensuring the quality of tests, and more.
IBT: What are the other significant things you experienced in this journey to curb ARS?
Dr Eisenkraft: In my years of developing medical countermeasures against the effects of ARS, I've had the opportunity to collaborate with incredible individuals from around the world from various fields of science, all of whom are motivated by the single goal of providing the most efficient and safe solutions against the potential threat of nuclear disasters.
Nevertheless, recognising the need to have effective solutions in place to combat the effects of ARS is not enough, and neither are the currently available measures, including GCSF, which have an effect only on white blood cells and thus can provide only a partial remedy against the haematological component of ARS.
The same way that governments stockpile arms and nuclear weapons, it is also their duty to stockpile readily-available, effective, protective measures and treatments to help citizens combat the dire effects of those same types of arms.
At Pluristem, we're developing our PLX-R18 cell therapies in a way that makes them effective and easily accessible while allowing them to be administered without requiring screening or tissue matching. Once people are exposed to high levels of radiation, time is of the essence, and that must be taken into consideration when developing treatments for ARS.
Once governments have PLX and other products in stock, it will allow them to have a ready and immediate response when faced with a nuclear disaster. In today's world, this is a basic and necessary level of preparedness, and we are extremely proud to be part of creating that solution.