More about MS and pathogenic MSRV 

Multiple Sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system. It is generally assumed that MS is mediated by an autoimmune process. Acute focal inflammation episodes in the central nervous system lead to nerve demyelination which is followed by axonal damage and loss.
 
The etiology of MS is uncertain but evidence suggests that genetic and environmental factors act in combination to result in MS.  Several studies have demonstrated the potential role of the MSRV endogenous retrovirus in MS.
 
MSRV had first been isolated from the cells of MS patients. MSRV is normally latent in the genome of individuals, but when activated by certain co-factors such as the common viruses, e.g. Herpes  Simplex virus 1 or Epstein Barr virus, it can be reactivated and express an envelope protein. This appears to be a major triggering and aggravating factor in the development and progression of MS, as shown in numerous scientific papers published by GeNeuro’s team and other leading academic centres.
 
The MSRV-Env protein has been identified in the MS plaques of patients as shown by the brown staining in the Figure below.

There is a high prevalence of MSRV RNA and DNA in the sera of MS patients when compared to controls. The presence of MSRV in MS patients correlates with the clinical progression, severity and prognosis of the disease, as reported by several independent laboratories.
 
The concentration level of retroviral pathogenic proteins also increases with progressive stages of the disease. In an antigenemia study conducted by GeNeuro, MSRV-Env was detected in the sera of approximately 75% of MS patients. The MSRV-Env protein has pro-inflammatory properties which translate into the production of different cytokines and the blockage of the capacity of oligodendrocytes to restore myelin destroyed in MS plaques.
 
The median prevalence of MS in Europe is about 80 per 100 000 and varies according to the country. The clinical course of MS varies considerably amongst patients. Three main clinical forms of MS are described: relapsing-remitting MS, secondary progressive MS and primary progressive MS. The first form is characterized by attacks and remissions and the two other forms by the progression of the neurological symptoms and disability. The duration and severity of the disease are difficult to foresee.
 
Currently, more than half a dozen disease modifying drugs are marketed for MS and more than 20 are in clinical development. None of them have really proven to stop the progression of the disease so far. Today, MS treatments can be divided into two basic categories: Disease modifying drugs, which modulate the immune system, decrease the rate of relapses but can induce frequent and sometimes severe adverse drug reactions; Symptomatic agents reduce specific symptoms associated with MS, such as spasticity, but they do not interact with the disease mechanism and do not affect disease progression. In addition, most of the current and in-development treatments are indicated for the relapsing-remitting form of MS, with few therapeutic options for the progressive forms of MS.

Therefore, clear unmet medical need exists for MS treatments that would offer better efficacy in terms of therapeutic benefit on disease progression, be well tolerated and treat the progressive forms of the disease.
 
GeNeuro has generated a humanized monoclonal antibody, GNbAC1, targeting the MSRV-Env protein. It is was developed to address an unmet medical need for patients suffering from MS by targeting MSRV-Env, which may be a key factor in the development of MS. The antibody acts upstream of the inflammatory cascade, representing a potentially new and well tolerated treatment for MS, without targeting the immune system itself. With a good safety profile and an alternative mechanism of action, the treatment may have a therapeutic effect on the both relapsing-remitting form as well as progressive forms of MS.