About Multiple Sclerosis
Multiple sclerosis (MS) is a nervous system disease that affects the brain and spinal cord. Multiple sclerosis is also known as:
- Disseminated sclerosis
- Encephalomyelitis disseminata
The disease affects the fatty myelin sheaths around the axons of the brain and spinal cord. These sheaths are damaged which leads to demyelination and scarring as well as a broad array of symptoms.
MS often hits individuals in the prime of their life (20-40 years of age), hence has devastating consequences not only for individuals but also for their families, friends and employers. The disease causes paralysis, and blindness in the most productive years of life.
Incidence Rate and Market Size
- It has a prevalence that ranges between 2 and 150 per 100,000 people
- In the US, the incidence rate for Multiple sclerosis is around 800,000 cases per year.
- The estimated annual medical cost per patient for chronic progressive MS in the United States in 1996 was US$50,000
- The current treatments have a market size of $2.5 billion
Treatments Available
- There is no known cure for MS
- The current treatments attempt to return some function after an attack and prevent new attacks or disability
- MS medications tend to have adverse side effects and many are poorly tolerated by patients
- There is no treatment available for the most debilitating form of the disease, namely primary progressive MS
Current FDA approved drugs include:
- Avonex (Interferon beta-1a)
- Betaseron; Extavia (Interferon beta-1b)
- Copaxone (Glatiramer acetate)
- Novantrone (Mitoxantrone)
- Tysabri® (Natalizumab)
Science of Multiple Sclerosis & NRPs Benefits
The disease Multiple Sclerosis (MS) is the most frequent of the de-myelinating central nervous system conditions and is more common in acclimated climate zones.
Differential vitamin D-dependent metabolism effects have been strongly implicated in the prevalence of the disease. Nevertheless, currently there is no direct link between environmental and/or genetic traits that can predict susceptibility to MS. 
There are different forms of disease severity, including relapsing-remitting disease patterns, secondary progressive MS and primary progressive MS.
Various drugs directed against the central nervous system (CNS) invading immune cells have been approved.
However, all available therapeutic approaches only aim to reduce relapse rates of the disease putting a clear emphasis on the control on the anti-inflammatory side of the immune system.
No approved drug provides a therapeutic impact regarding the repair of previously damaged CNS (e.g. reduction of existing MS plaques that represent areas of largely de-myelinated regions with ruptured electrical connections).
Therefore there is an unmet medical need for CNS-regenerative therapies within the more severe and progressed forms of MS.
Animal Models
- One animal model mimicking severe MS is the experimental autoimmune encephalitis (EAE) mouse model.
- Disease is induced by repeated injection of a protein that is part of the electrically insulating fat/protein layer of the nervous fibre.
Mice develop severe forms of paralysis and tetraplegia coinciding with a strong autoimmune response against the nervous fibre insulation.
The FDA-approved drugs show various beneficial activities when applied in a prophylactic manner to the EAE mice while therapeutic treatment (start of drug administration at the height of disease) do not show significant beneficial effects.
The drug erythropoietin (EPO) reveals the highest beneficial effects during EAE therapeutic treatment. However, disadvantages of EPO are its large molecular size that makes peripheral administration strategies challenging and its strong side effects on immune and blood cell generation.
For Multiple Sclerosis:
- NRPs are highly effective in the lower μg/kg range in EAE mice
- Strong effects in prophylactic and therapeutic applications
- Peripheral IP injection is the preferred route of administration
