for Multiple Sclerosis
One of the most devastating diseases of the central nervous system is Multiple Sclerosis (MS). MS is a lifelong and progressive debilitating autoimmune disease affecting the brain and spinal cord. Both genetic (the strongest link being the HLA-DRB1 locus in the class II region of the MHC) and environmental factors play a role in susceptibility and initiation of the disease. People are very often diagnosed early in life, usually in their thirties. Subtle, early symptoms in many patients manifest many years before being diagnosed. As in other autoimmune disease such as rheumatoid arthritis, women are disproportionally affected, almost three times as many women as men suffer from MS. Progressive neurological disability can occur right from the onset (~10% of the cases) or in a remitting-relapsing manner (~90% of the cases). It is estimated that 2.3 million people suffer from MS worldwide.
The body’s immune system loses self-tolerance to myelin, a sheath covering and insulating the long nerve fibres carrying nerve electric impulses from the centre to the periphery. There are pathological T immune cell responses against self-proteins like myelinbasic protein (MBP), proteolipid protein (PLP) and myelin-oligodendrocyte glycoprotein (MOG). In MS the autoimmunity damages and destroys partially or completely the myelin sheaths, thus leaving scars visible as sclerotic plaques on Magnetic Resonance Imaging (MRI); a hallmark of the disease. The key function of the myelin sheath, which is to facilitate the signal transmission to the body to function, is thereby greatly impaired and damaged. Depending on which parts of the nervous system most affected, the clinical symptoms varies. Blurred vision, fatigue, pins and needles, walking difficulties are frequently the early signs. Sensory, motor and cognitive functions are affected. The diagnosis (2017 McDonald diagnostic criteria) is based on a combination of the clinical symptoms, MRI findings (gadolinium enhancing lesions/sclerotic plaques) and analysis of the fluid in the central nervous system. The assessment of the disability progression in MS is rather difficult to quantify as it affects multiple functional domains in various degrees and often subtlety for periods of time. In clinical routine practice the multiple sclerosis performance test (MSPT) is recommended. This is important as it can gauge the efficacy of any therapy currently used to modify the disease or efficacy of any new intervention in a trial setting.
There is no curative therapy available for MS. A couple of anti-inflammatory disease modifying therapies (DMTs) have been approved for treatments; all are immunosuppressive agents against B-cells (such as anti-CD20) or T- cells (such as Cladribine). All these agents have serious side-effects and none reverse or even stop the progression of the autoimmune destruction. Multiple agents are in clinical trials including stem cell therapy.
The current therapeutic arsenal is grossly deficient. There is a clear need for new therapeutic modality to arrest this devastating autoimmune disease.
Our Antigenic Immune Modulation (AIM) therapeutic platform is a logical and most promising strategy to address self-antigen driven autoimmunity. The AIM is to re-establish the balance of tolerance by enhancing the regulatory immune pathways without any immune suppression.