Prof G's MS Blog Archive

European Commission approves Fingolimod, the first oral multiple sclerosis treatment for use in the EU.
(1) Fingolimod is approved in the EU for people with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS. (2) Fingolimod showed superior efficacy to interferon beta-1a IM, a commonly prescribed treatment, reducing relapses by 52% (p<0.001) at one year. (3) Two-year, placebo-controlled study demonstrated that Fingolimod significantly reduced the risk of disability progression.

Click here to see a YouTube clip of Fingolimod’s mode of action

Click here for PBS webcast

Click here to download details!

Le Page E, et al. Long-term safety profile of mitoxantrone in a French cohort of 802 multiple sclerosis patients: a 5-year prospective study. Mult Scler. 2011 Feb 15;. [Epub ahead of print]

Towards an endophenotype in multiple sclerosis

This study is recruiting people with MS who have brothers and/or sisters without MS, and people with MS who are twins (identical and non-identical) to explore the cause of MS, a multi-factorial disease. Twins may help the researchers understand the cause of disease and the influence of early environmental exposures; identical twins have the same genetic background and twins in general share the same early environment, which can be different when looking at non twins and unrelated individuals.

What will participants be asked to do?

If you decide to take part, you will be asked to contact your sibling(s) in order to see if they would be happy to take part in this study. If they are happy to take part, then the researchers would be able to see you either together or at separate times, at your convenience.

The researchers would take approximately three tablespoons (45ml) of your blood from a vein in your arm, which is likely to be at the same time as any other blood tests you might be having. Participants would be asked to provide a urine sample, a cheek swab and a saliva sample on the same day as having the blood test.

Who can take part?

The study is looking to recruit participants who have been diagnosed with multiple sclerosis and have a brother or sister who does not have MS and is able to take part in this research.
Who is conducting the research?

This research is being carried out by research doctors and scientists under the direction of Professor Gavin Giovannoni. Sections of this research are being carried out as part of PhD by Dr Dobson.

Who has reviewed this study?

Approval for this project has been granted by the East London Research Ethics Committee 2 (ref 10/H0704/62).

Interested?

If you would like to find out more about this study and would like to receive a participation information sheet, please contact either Dr Ruth Dobson (ruth.dobson@qmul.ac.uk, 020 7882 2282) or Ms Maria Espasandin (m.espasandin@qmul.ac.uk 020 7377 7000 ext. 3303) for further details. Please note that enquiring about participation does not commit you in any way

MS Society Website

Genzyme is the company that is developing Alemtuzumab (formerly known as Campath-1h) for MS. Alemtuzumab is clearly the most effective of the emerging drugs in clinical development. Sanofi on the other hand are developing Teriflunomide, an oral disease-modifying therapy, that has been reported to reduce the attack rate in relapsing-remitting MS compared to placebo by about 30%. How will Sanofi integrate these two compounds into clinical practice? Will Alemtuzumab be used as induction therapy and Teriflunomide as maintenance therapy? What is clear is that Sanofi will become a major player in the MS arena.

Click here for a commentary from Market Watch

Retroviruses are viruses that have integrated into our genome and are passed on to our offspring. By analyzing DNA investigators have found that variations in a gene called TRIM5 and a retroviral insertion site correlated with MS. Clearly these results need to be confirmed. If they are confirmed we will need to incorporate retroviruses into our models of MS.

Nexø BA, et al. The Etiology of Multiple Sclerosis: Genetic Evidence for the Involvement of the Human Endogenous Retrovirus HERV-Fc1.PLoS One. 2011 Feb 2;6(2):e16652.

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The European Medicines Agency confirmed its previous negative opinion and adopted a final negative opinion, recommending that oral cladribine, from Serono Europe Ltd, should not be granted a marketing authorisation. Oral cladribine was intended as disease-modifying therapy in relapsing remitting multiple sclerosis.

Click here for EMA statement

European Medicine’s agency gives a negative opinion for fampridine:

“The Committee adopted a negative opinion recommending that fampridine, from Biogen-Idec Ltd, should not be granted a marketing authorisation. Fampyra was intended to be used to improve the walking ability of adult patients with multiple sclerosis.”

Where to next?

Click here for EMA notification

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that:

Fingolimod is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following adult patient groups:

Patients with high disease activity despite treatment with a beta-interferon. These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of beta-interferon. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion. A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.

OR

Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Click here for summary report