Approximately 2.5 million people worldwide are affected by multiple sclerosis (MS). In the US, approximately 400,000 people have the disease, with around 25,000 new cases diagnosed each year. The combined value of the five drugs marketed globally for MS was estimated at US$3.6 billion for 2004 and this is expected to grow to $6.9 billion in 2009.

The disease attacks the central nervous system and is characterised by the progressive destruction of the myelin sheath that protects the nerves and allows nerve impulses to be transmitted. MS begins with reversible neuropsychological defects (relapsing-remitting (RR) type), followed by progressive disease and neurological decline over the years. Symptoms include effects on vision, memory and other aspects of mental function, coordination, muscle spasms or weakness, pain, overwhelming fatigue, depression, heat intolerance, and urinary and bowel problems. Death is rare but the disease can be seriously disabling.

There is currently no cure for MS or any of its symptoms and no drug has been approved for treating primary progressive MS – the most aggressive form of the disease. Treatments available now either slow down the course of the disease or relieve some of its symptoms. All cause varying side effects, only work for some patients and create immune resistance over time for at least some sufferers. As a result, individuals may move from one treatment to another. Treatment side effects include various auto-immune reactions, capillary leak syndrome, anaphylactic shock, insomnia, headache, alopecia, and depression.

Neutralising antibodies are a very significant side-effect of conventional treatments for relapsing-remitting multiple sclerosis. The antibodies develop in approximately 30% of patients, and can reduce clinical efficacy.

Apollo expects its treatment will be less likely to these problems than with existing biopharmaceuticals, because the glycosylation on its protein more closely resembles natural human structures. As a result, patients should tolerate the treatment for longer, with fewer immune-related side effects. The treatment should be an option for those who have exhausted existing products. A properly human-glycosylated product does not exist in the marketplace. Apollo aims to supply the first human cell produced (hcx™) therapeutic for this condition.