A window of hope for millions of patients around the world with Multiple Sclerosis “opens” the trial remyelination treatment Diaprotectome™ discovered by a research team of Monash University in Australia led by the expatriate neuroscientist Steven Petratos.

In Greece, Multiple Sclerosis, based on a recent pharmacoepidemiological study, affects more than 21,200 patients with an average age of diagnosis of 30 years. With the aim of developing a treatment that will not only stop the progression of the disease, but possibly reverse it, NeuOrphan LTD (a Greek-owned interest in Australia that owns the intellectual property of the new investigational drug) plans to hold the European Clinics in Greece Trials under the name ‘Odyssey’.

Once approved, clinical trials for the Diaprotectome™ will be conducted on a case-by-case basis and on the basis of relevant physician interest in at least 10 university, general and military hospitals throughout Greece from Crete to Evros for 12 months. The upcoming 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 the implementation of this as well as others of clinical studies on the disease in Greece. The Network aims to reduce the organizational, financial and geographical barriers that hinder patients’ timely access to health services and innovative therapeutic interventions. The coordinator of the “Odyssey” clinical study is the Professor of Neurology of the AUTH, Nikolaos Grigoriadis. The aim is to enroll in the study up to 400 people with Multiple Sclerosis in all stages of the disease up to EDSS level 6 (that is, excluding people in a wheelchair), for whom the treatment options to control the progression of the disease are currently limited.

Diaprotectome™ has been developed to attempt to repair the damage that develops within the Central Nervous System during the course of Multiple Sclerosis. It is a small molecule that, in an experimental stage, appears to have the ability to protect the nerve cells of the Central Nervous System by operating at two levels. At the first level it stops the further destruction of myelin, the protective covering of neurons, which shields the nerve fibers allowing the rapid propagation of nerve signals throughout the body, and at the second level it stimulates the creation of new myelin (remyelination). The results from the preclinical tests done in Greece, Australia and Israel were impressive. Paralyzed laboratory animals were able to walk again as normal nervous system function was restored.

“I am very optimistic. All preclinical tests have been based on current scientific documentation very successful and we have also secured an international patent. 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 tests will start in the middle of next year, when all approvals from the Regulatory Authorities will be secured. We are trying to ensure that trial sites are ready to receive participants and that we have the drug available. We have secured all the required contracts with the drug research and manufacturing organizations, which we will submit to the Regulatory Authorities.’

The advantages of the treatment are that it is easily administered orally, as it is in pill form and that it will be taken alongside the treatment the participants are already taking, without having to stop any medication (adjunctive therapy). In addition, Diaprotectome™ has been proven safe for use in humans, as it is based on a known drug already used to treat a rare genetic condition in children.

“Carrying out epidemiological and clinical research is a necessary condition in the direction of finding solutions for Multiple Sclerosis” points out the professor of neurology, Nikolaos Grigoriadis, underlining that “this innovative research program presented today also marks the entry of Greece into the world map of countries that make substantial and high-level efforts to improve the treatment of the problems of People with Multiple Sclerosis”.

People with Multiple Sclerosis themselves are eagerly awaiting the start of Clinical Trials. “Sometimes MS is friendly and other times it’s like we have a tank in front of us and we’re throwing rocks. Now, with this medicine, we hope that the little stones will become munitions capable of stopping the uncontrolled course of the disease,” says Dimitra Gasouka, who has been living with Multiple Sclerosis for 22 years.

Corresponding clinical studies will then be carried out in the USA. If and when the Phase II Clinical Trials are successfully completed, they will continue globally in order for the drug to be licensed and put into mass production.

A few words about Multiple Sclerosis:

Multiple Sclerosis is a chronic inflammatory neurological disease that attacks the brain and spinal cord causing degenerative changes that lead to neurological symptoms and accumulating disability. These are diseases, the severity of which varies, causing a wide range of symptoms from depression, fatigue, disorientation and cognitive or vision problems to difficulty speaking, movement problems and even paralysis. In fact, it is the most common non-traumatic cause of neurological disability in young adults. The socio-economic burden on the patient, his family and the health system is enormous. In Europe the average annual expenditure (public and private) for the management of Multiple Sclerosis for each patient amounts to 40,303 euros. Worldwide, it is estimated that approximately 2.3 million people suffer from 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 progression of the disease. This gap Diaprotectome™ aspires to fill, however, remains to be established through clinical studies.