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Research news - October 2006

Way Ahead 2006;10(4):3
  1. Mitoxantrone and glatiramer acetate: positive results seen
  2. Tysabri licensed
  3. CLARITY study to expand
  4. Epstein Barr Virus and MS: not enough evidence
  5. CUPID trial now recruiting

1. Mitoxantrone and glatiramer acetate: positive results seen

A group from the Walton Centre, Liverpool, recently reported promising results from a small, open-label, combination study in the Journal of Neurology. The protocol used mitoxantrone followed by glatiramer acetate (Copaxone) as maintenance disease modifying therapy. The combination was shown to reduce both the relapse rate and disease progression in the 27 participants treated so far, who all had aggressive relapsing/remitting MS. A larger single-blinded research trial, 'The United Kingdom early Mitoxantrone trial', has now started recruiting at centres around the UK to investigate the combination further. The treatment will be compared against high-dose interferon beta treatment (Rebif 44).

For more information see the study website.

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2. Tysabri licensed

On 29 June 2006, the European Commission approved Tysabri as a single disease modifying therapy for relapsing/remitting MS to prevent relapses and delay progression of disability. However, due to safety concerns, treatment with Tysabri has been restricted to the following patient groups:

  • people with highly active relapsing/remitting MS who have failed to respond to treatment with beta interferon. Patients should have had at least one relapse in the previous year whilst on therapy and have evidence of lesions on their MRI scan; or
  • people with rapidly evolving severe relapsing/remitting MS. Defined as having two or more disabling relapses in one year and with evidence of increasing lesions on two consecutive MRI scans.

NICE has indicated it will assess Tysabri through its rapid assessment process. For more information, see the MS Trust's Tysabri factsheet.

Source: EMEA website

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3. CLARITY study to expand

The phase III CLARITY study (CLAdRIbine Tablets treating MS orallY), which is testing the safety and efficacy of oral cladribine (Mylinax) in people with relapsing/remitting MS, is set to expand. After successfully recruiting participants from outside the US in 2005, the trial will now expand to include 17 centres in America. In total, more than 1,200 participants will be involved in the two-year, double-blind placebo controlled study. The trial is designed to evaluate the effect on relapse rate, disease progression and MRI activity. Previous trials of cladribine administered by injection showed a positive effect on relapse rate and new lesion development.

Source: Medical News Today

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4. Epstein Barr Virus and MS: not enough evidence

A meeting held at the Royal Society of Medicine in May concluded that there is currently insufficient data to support the claim that 'EBV is the possible cause of MS.' MS is thought to be triggered in genetically susceptible people as a result of exposure to an environmental agent or agents. There have been numerous claims over the years that different viruses cause MS, but no substantive proof has been found to date. The most recent viral candidate to be linked with MS is EBV, which causes glandular fever. Experts in virology, multiple sclerosis, epidemiology and immunology, as well as a small group of people with MS attended the Royal Society meeting. It was agreed that there were too many unanswered questions, and that further research was required, to explain the link between EBV infection and MS and that to support a causal link on the current evidence would be premature and irresponsible.

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5. CUPID trial now recruiting

Recruitment to the CUPID trial (Cannabis Use in Progressive Inflammatory brain Disease) has now begun. To date 36 participants have been enrolled at the Plymouth centre and a further four at Aberdeen, the study hopes to recruit around 500 people in total with 28 centres involved. The study aims to evaluate whether cannabis can slow disability and have a neuroprotective effect in people with progressive MS who are able to walk a short distance. It will also assess long-term safety.

For further information on the trial, including full criteria and the participating centres, visit the trial's website.

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