Researchers successfully complete phase III clinical trials

Nov 14, 2011 14:38 GMT  ·  By

Researchers at the University of Cambridge are excited to announce that the coronation of nearly 30 years of hard work is at hand – a new type of treatment for multiple sclerosis. The condition is currently lethal and incurable, so any breakthrough could literally be life-saving.

The prospect of having access to a new type of approach in treating this extremely dangerous condition is exciting to investigators, who have been trying to battle the disease – albeit unsuccessfully – for many years. This condition belongs to a class known as autoimmune disorders.

What this means is that a patient's own immune system erroneously believes that certain parts of the body are foreign, and starts to attack them. In the case of MS, the target is the myelin sheet surrounding nerve cells called neurons.

The myelin sheet is absolutely critical to the normal functioning of the brain, since it insulates the neurons from each other, allowing electrical impulses to be passed from one nerve cell to the next. Without it, the signals diffuse into surrounding neurons, causing massive damage.

Researchers at Cambridge began experimenting with the chronic lymphocytic leukaemia drug alemtuzumab as a potential treatment for multiple sclerosis back in 1991. Today, November 14, the results of two Phase III trials (CARE – MS2) were published.

The studies were carried out under the supervision of head of the Department of Clinical Neurosciences at the university, professor Alastair Compston, who worked closely with colleague Dr Alasdair Coles, a lecturer in the same department.

“CARE-MS2 represents the culmination of many years clinical and laboratory research aimed at demonstrating the potential for alemtuzumab as a highly effective treatment for multiple sclerosis and understanding mechanisms involved in the complex natural history of the disease,” Compston says.

“Taken together, the phase II and III clinical trial data illustrate the promise that alemtuzumab holds as a transformative treatment for a broad range of people with relapsing multiple sclerosis,” he adds.

“Three important results emerge from these trials. First, they show that just eight days of alemtuzumab significantly reduces the risk of having another relapse of multiple sclerosis or becoming disabled over the next 3 to 5 years, compared to the standard active drug, interferon-beta,” Coles explains.

“ Secondly, many patients on alemtuzumab experience an improvement in disability, which is not seen after standard treatment. Finally, although alemtuzumab causes potentially serious side-effects, these can be identified and treated provided a monitoring schedule is carefully followed,” he concludes.