OR multiple sclerosis is a chronic inflammatory neurological disease that affects the brain and spinal cord, causing degenerative changes that lead to neurological symptoms and accumulation of disability.

Worldwide, it is estimated that approximately 2.3 million people suffer from multiple sclerosis.

In Greecemultiple sclerosis based on a recent pharmacoepidemiological study affects more than 21,200 patients with an average age of diagnosis of 30 years.

In the laboratory of the Department of Neuroscience at Monash University in Melbourne, of which he is the head, the distinguished expatriate scientist Steven Petratos and his team have been studying for several years a particular moleculefor multiple sclerosis and the preclinical results are encouraging.

The goal is the effort repairing the damage that develop within the Central Nervous System during the course of multiple sclerosis.

Today there are 19 approved MS drugs that offer quality of life by controlling relapses. However, none of these drugs stop or reverse the disease’s progression, the scientists report.

This gap he aspires to fill Diaprotectomewhich however remains to be established through clinical studies.

Diaprotectome has been shown to be safe for use in humans because it is based on a known drug already used to treat a rare genetic condition in children, they add.

The advantages of the treatment are that it is easily administered oralas it is in the form of a pill and that it will be taken alongside the treatment that the participants are already taking, without having to stop any medication (complementary treatment).

As Steven Petratos explains to APE-MPE, “experiments on mice have shown that the daily oral administration of the drug Dioprotectome limits the demyelination of the spinal cord and the degeneration of nerve fibers through neuroprotection mechanisms in the context of neuroinflammation. Additionally, mice that experienced peak neurological symptoms, including paralysis, recovered and were able to walk again. We demonstrated that recovery coincided with remyelination.” According to the findings of the scientists, this drug promotes the remyelination of cells of the central nervous system.

Scientists are recording an increasing trend in the prevalence and incidence of the disease and are investigating various factors.

As the Professor of Neurology of AUTH, Nikolaos Grigoriadis, explains to APE-MPE, one reason may be the improved possibility of diagnosis that exists today compared to the past. On the other hand, factors such as diet and modern lifestyle are blamed, but with epigenetic changes that may occur over time, environmental factors, etc.

In the middle of next year, clinical trials in Greece

Mr. Petratos is currently in Greece and has meetings with representatives of the State and scientific bodies for the development of clinical studies in Greece as well, which are expected to start in the middle of next year.

“We are on the verge of starting phase II trials in Australia and at the same time in Greece” notes Dr. Petratos, estimating that “the trials will begin in the middle of next year, when all approvals from the Regulatory Authorities will be secured. We are currently writing and preparing regulatory documents to be submitted to the TGA in Australia and the EMA in Europe. Once they approve the trials, then we expect to start recruiting participants.” He explains that “the new treatment will include all people living with multiple sclerosis, but we want to recruit many participants with primary and secondary progressive MS to demonstrate the effectiveness on changes in cognitive function and fatigue.”

On his part, Mr. Grigoriadis states that the National Network for Multiple Sclerosis, as designed by the Hellenic Academy of Neuroimmunology (HELLANA) and the Multiple Sclerosis Center of the 2nd Neurological Clinic of AUTH at the AHEPA Hospital, is expected to facilitate this as well as other clinical studies on the disease in Greece.

He notes that centers from all over Greece will be included in this study based on the interest shown by the attending physicians of these centers. “It is interesting that as many centers as possible participate in order to have representation regarding ‘People with Multiple Sclerosis’ from all over Greece. Doing so increases the credibility of the study. It is planned to enroll 400 patients and the criteria will be defined in the protocol whose writing is currently being completed”, he emphasizes to APE-MPE.

The scientists expect benefits regarding the progression of the patients’ disability and mainly, in terms of cognitive function and fatigue as primary endpoints, but also the progression of the disability, quality of life and the patients’ self-reports of their condition.

Mr. Petratos, explains that “after a successful phase 2 trial, it will be necessary to conduct a very large-scale multicenter phase III trial, which will compare this drug with other drugs currently being tested for MS progression. These trials may take over 2 years to obtain valid and reliable results, which will require regulatory agencies to register the drug for marketing.”