Guillaume Blivet, co-founder and president of REGEnLIFE

REGEnLIFE, a company specialized in the research and development of innovative photo-medical technologies for the prevention and treatment of neurodegenerative diseases, has seen promising results of the pilot clinical trial evaluating its technology in Alzheimer’s disease (AD). The results were presented by Professor Jacques Touchon, scientific advisor on the trial, at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2021), held online from March 9 to 14, 2021.

REGEnLIFE’s innovative non-invasive technology is based on photobiomodulation, targeting both the brain and gut via a helmet and abdominal device. This cutting-edge medical device, RGn530, stimulates cells in the brain and gut and regulates inflammation – to improve cognitive functions and behaviour. It targets inflammation of the gut-brain axis, which is believed to be linked to the development of AD and other neurodegenerative diseases.

“There are increasing scientific data to endorse the hypothesis that the gut-brain axis is involved in the development of AD and other neurodegenerative disorders. We also believe that some forms of electromagnetic emissions could prevent and treat this disease. Our initial clinical data, coupled with all our preclinical proof of concept studies, led us to pursue a pivotal clinical study in AD and to consider working on other neurological diseases,” said Guillaume Blivet, co-founder and president of REGEnLIFE. “To accelerate this new phase in our development and to shortly gain early market access, we are preparing a new funding round before the end of 2021.”

REGEnLIFE’s technology safe and well-tolerated
The trial enrolled adult volunteers aged 55 to 85, with mild to moderate Alzheimer’s disease. They were equipped with a helmet and a photobiomodulation abdominal belt; the patients benefited from a total of 40 sessions; these lasted for 25 minutes and were spread over a two-month period. The volunteers were evaluated in a series of tests during the trial and up to one month after treatment ended. This double-blind, randomized, monocenter, placebo-controlled clinical trial began in 2018; it ended prematurely in 2020 due to the COVID-19 pandemic. Out of the 64 planned patients, 53 were randomized into two groups (treated and placebo) and 43 patients benefited from the full duration of the treatment.

The primary efficacy endpoint was measured by the evolution of the total ADAS-Cog score, (Alzheimer’s Disease Assessment Scale), between inclusion and the end of the two-month period of treatment. The REGEnLIFE RGn530 device was shown to be safe; no major side effects were reported. Compliance with treatment sessions was very high for the vast majority of patients (92%). This level of compliance also confirms the good tolerance of the device. While the primary efficacy endpoint was not statistically met, there was a clear improvement trend in a set of cognitive functions. The results of this pilot study showed that REGEnLIFE’s technology is safe and well-tolerated by patients. These very encouraging safety and efficacy results will now be confirmed in a pivotal or phase III clinical trial.

“The therapeutic strategy for AD should involve several targets. Drug treatments targeting the two characteristic proteins of the Alzheimer’s process (beta-amyloid and tau proteins) must be supplemented by other therapies – targeting less specific but very important mechanisms in the pathophysiological AD cascade, such as inflammation and oxidative stress,” said Professor Jacques Touchon, neurologist and psychiatrist, scientific advisor on the clinical trial. “REGEnLIFE’s photobiomodulation technology acts at the early stages of this cascade, (mitochondria, inflammation, oxidative stress), and could be the non-drug complement to the next-generation therapeutic strategy. This technology also makes it possible to act on both the brain and the gut, a significant advantage when we know the important role of the gut-brain axis and microbiota in neurodegenerative pathologies.”

Photobiomodulation technology
Photobiomodulation is based on photonic emissions in the near-infrared, it has already shown analgesic, anti-inflammatory and healing properties. One of the most reproducible effects is the overall reduction in inflammation, especially in the brain < https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1016/j.trci.2017.12.003 >. REGEnLIFE’s technology could therefore be used on brain diseases and on pathologies linked to neuroinflammation. REGEnLIFE developed this device employing this scientific approach, using medical technology never before applied to neurology.

According to Alzheimer’s Disease International, 35 million patients worldwide have AD. The annual cost of the disease worldwide is estimated at €850bn. Currently, there are no treatments to cure Alzheimer’s.

In order to address public health issues related to a disease that affects elderly and vulnerable people, REGEnLIFE chose to develop a non-invasive technology with low constraints for patients. The cost of this device is expected to be reasonable for patients and national healthcare systems.

Cells used to study the human blood-brain barrier in the lab aren’t what they seem, throwing nearly a decade’s worth of research into question, a new study from scientists at Columbia University Vagelos College of Physicians and Surgeons and Weill Cornell Medicine suggests.

The team also discovered a possible way to correct the error, raising hopes of creating a more accurate model of the human blood-brain barrier for studying certain neurological diseases and developing drugs that can cross it.

The study was published online Feb. 4 in the Proceedings of the National Academy of Sciences (PNAS).

“The blood-brain barrier is difficult to study in humans and there are many differences between the human and animal blood-brain barrier. So it’s very helpful to have a model of the human blood-brain barrier in a dish,” says co-study leader Dritan Agalliu, Ph.D., associate professor of pathology and cell biology (in neurology) at Columbia University Vagelos College of Physicians and Surgeons.

The in vitro human blood-brain barrier model, developed in 2012, is made by coaxing differentiated adult cells, such as skin cells, into stem cells that behave like embryonic stem cells. These induced pluripotent stem cells can then be transformed into mature cells of almost any type – including a type of endothelial cell that lines the blood vessels of the brain and spinal cord and forms a unique barrier that normally restricts the entry of potentially dangerous substances, antibodies, and immune cells from the bloodstream into the brain.

Agalliu previously noticed that these induced human “brain microvascular endothelial cells,” produced using the published approach in 2012, did not behave like normal endothelial cells in the human brain. “This raised my suspicion that the protocol for making the barrier’s endothelial cells may have generated cells of the wrong identity,” says Agalliu.

“At the same time the Weill Cornell Medicine team had similar suspicions, so we teamed up to reproduce the protocol and perform bulk and single-cell RNA sequencing of these cells.”

Their analysis revealed that the supposed human brain endothelial cells were missing several key proteins found in natural endothelial cells and had more in common with a completely different type of cell (epithelial) that is normally not found in the brain.

The team also identified three genes that, when activated within induced pluripotent cells, lead to the creation of cells that behave more like bona fide endothelial cells. More work is still needed, Agalliu says, to create endothelial cells that produce a reliable model of the human blood-brain barrier. His team is working to address this problem.

Reference:

https://doi.org/10.1073/pnas.2016950118

The Oxford Academic Health Science Network (AHSN) has recently published a study exploring the use of point-of-care (PoC) testing within a busy GP group practice in the United Kingdom, using HORIBA Medical’s novel Microsemi CRP PoC haematology analyser.

Proton therapy, a type of external beam radiation therapy, is a safe and effective treatment for prostate cancer, according to two new studies.
In the first study, researchers at the University of Florida in Jacksonville, Fla., prospectively studied 211 men with low-, intermediate-, and high-risk prostate cancer. The men were treated with proton therapy, a specialised type of external beam radiation therapy that uses protons instead of X-rays. After a two year follow-up, the research team led by Nancy Mendenhall, MD, of the University of Florida Proton Therapy Institute, reported that the treatment was effective and that the gastrointestinal and genitourinary side effects were generally minimal.
‘This study is important because it will help set normal tissue guidelines in future trials,’ Dr. Mendenhall, said.
In the second study, researchers from Massachusetts General Hospital in Boston, Loma Linda University Medical Center in Loma Linda, Calif., and the Radiation Therapy Oncology Group in Philadelphia performed a case-matched analysis comparing high-dose external beam radiation therapy using a combination of photons (X-rays) and protons with brachytherapy (radioactive seed implants).
Over three years, 196 patients received the external beam treatments. Their data was compared to 203 men of similar stages who received brachytherapy over the same time period. Researchers then compared the biochemical failure rates (a statistical measure of whether the cancer relapses) and determined that men who received the proton/photon therapy had the same rate of recurrence as the men who received brachytherapy.
‘For men with prostate cancer, brachytherapy and external beam radiation therapy using photons and protons are both highly effective treatments with similar relapse rates,’ John J. Coen, MD, a radiation oncologist at Massachusetts General Hospital in Boston, said. ‘Based on this data, it is our belief that men with prostate cancer can reasonably choose either treatment for localised prostate cancer based on their own concerns about quality of life without fearing they are compromising their chance for a cure.’ EurekAlert