Promising new results for Fingolimod, an experimental oral treatment for people with relapsing remitting MS
10 Oct 2006
Novartis Pharmaceuticals have presented new positive results with Fingolimod (FTY720) and have initiated a worldwide phase III clinical study.
Following a two-year phase II clinical study, Novartis reported a relapse rate reduction of more then 50%, compared to placebo, with 77% of people taking Fingolimod remaining relapse-free over two years. In addition, more then 80% of people were free from lesions showing active inflammation on MRI. People taking placebo in the first six months of the trial experienced a similar improvement, when switched to Fingolimod. This finding was sustained for 24 months.
Overall, the drug was well tolerated. Reported side effects were usually mild and included: upper respiratory tract infections, nausea, diarrhoea, initial decrease in heart rate and an increase in blood pressure.
Simon Gillespie, chief executive at the MS Society, said: ‘we are excited at the prospect of an effective and well tolerated oral treatment for relapsing remitting MS which is urgently needed and welcome the initiation of phase III clinical trial.”
Based on the promising phase II results, Novartis has initiated a phase III study programme with plans to involve more than 3000 people with MS worldwide.
The first planned multi-centre study, called FREEDOMS plans to evaluate the effectiveness and safety of two different doses of Fingolimod, compared to placebo over 24 months. It will be recruiting people between the age of 18 and 55 with relapsing-remitting MS that must have experienced 1 relapse in the last year or 2 relapses in the last 2 years.
Confirmed participating clinical centres (not recruiting yet) in the UK include: The Royal Victoria Infirmary, Newcastle-upon-Tyne;
Queens Medical Centre, Nottingham; Hope Hospital, Salford; Royal Hallamshire Hospital, Sheffield; Barts and the London NHS Trust, The Royal London Hospital, St. George's Hospital, Tooting and King's College Hospital in London. For more details on this study please refer to http://www.clinicaltrials.gov/ct/show/NCT00289978
What is Fingolimod?
Fingolimod (FTY720) is a new oral immunomodulating treatment under evaluation for the treatment of relapsing remitting MS. It's a chemical derivative of a metabolite produced by a fungus used in traditional Chinese medicine.
Fingolimod has a novel mechanism of action. It binds to a receptor on a proportion of circulating immune cells and reversibly traps them in the lymph nodes. As a result, Fingolimod lowers the number of activated immune cells circulating in the blood stream and prevents them from attacking the brain and spinal cord.
Overall, the drug was well tolerated. Reported side effects were usually mild and included: upper respiratory tract infections, nausea, diarrhoea, initial decrease in heart rate and an increase in blood pressure.
Simon Gillespie, chief executive at the MS Society, said: ‘we are excited at the prospect of an effective and well tolerated oral treatment for relapsing remitting MS which is urgently needed and welcome the initiation of phase III clinical trial.”
Based on the promising phase II results, Novartis has initiated a phase III study programme with plans to involve more than 3000 people with MS worldwide.
The first planned multi-centre study, called FREEDOMS plans to evaluate the effectiveness and safety of two different doses of Fingolimod, compared to placebo over 24 months. It will be recruiting people between the age of 18 and 55 with relapsing-remitting MS that must have experienced 1 relapse in the last year or 2 relapses in the last 2 years.
Confirmed participating clinical centres (not recruiting yet) in the UK include: The Royal Victoria Infirmary, Newcastle-upon-Tyne;
Queens Medical Centre, Nottingham; Hope Hospital, Salford; Royal Hallamshire Hospital, Sheffield; Barts and the London NHS Trust, The Royal London Hospital, St. George's Hospital, Tooting and King's College Hospital in London. For more details on this study please refer to http://www.clinicaltrials.gov/ct/show/NCT00289978
What is Fingolimod?
Fingolimod (FTY720) is a new oral immunomodulating treatment under evaluation for the treatment of relapsing remitting MS. It's a chemical derivative of a metabolite produced by a fungus used in traditional Chinese medicine.
Fingolimod has a novel mechanism of action. It binds to a receptor on a proportion of circulating immune cells and reversibly traps them in the lymph nodes. As a result, Fingolimod lowers the number of activated immune cells circulating in the blood stream and prevents them from attacking the brain and spinal cord.
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