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Interferon phase III study commences

Biogen Idec is to start a phase III trial to evaluate the efficacy and safety of PEGylated Interferon beta-1a in patients with relapsing multiple sclerosis

Biogen Idec has announced the start of a phase III trial to evaluate the efficacy and safety of PEGylated Interferon beta-1a in patients with relapsing multiple sclerosis (RMS).

The first of an intended 1,200 patients, aged between 18 and 55, has been enrolled to take part in this two-year, multi-centre study.

Interferon beta-1a has been successfully used to treat patients with RMS for more than 10 years. However, the required frequency of the injections has been a major issue among patients. Examined in phase I studies, it found that PEGylation protects the interferon beta-1a molecule from being degraded, extending the amount of time the drug remains in a patient's system.

Dr Peter Calabresi, principal investigator of the trial and professor of neurology and director of The Johns Hopkins Multiple Sclerosis Center, Baltimore, US, said that further to the phase I findings: "It offers the possibility of every two- or four-week dosing without compromising efficacy. This would greatly increase the convenience of this first-line class of therapy."

Details announced in 2008 of an early stage study of 287 people over two years, funded by the UK Multiple Sclerosis (MS) Society, showed that genetic differences between people may be implicated in their response to treatment with beta interferon. (There are currently three beta interferon medications used to treat RMS.)

In December last year interim results for a phase III clinical trial of FTY720 (Fingolimod) were released by Novartis, one of a number of therapies being trialled for RMS. The oral drug has been cited as an alternative treatment option to reduce the number of relapses.

Earlier this month, the MS Society said that new research showed that the number of people with MS in the UK is likely to be around 100,000 – a 20 per cent increase on previous estimates.

23rd June 2009

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