Promising early results for Campath in relapsing remitting MS
03 May 2007
The Multiple Sclerosis Society has welcomed the interim results of a phase II trial of Campath (alemtuzumab). They show that people with multiple sclerosis taking the drug at both high and low doses experienced at least a 75% reduction in the risk of a relapse, compared with those taking Rebif (interferon beta-1a), after more than two years of follow-up. They also experienced at least a 65% reduction in the risk of progression of clinically significant disability. Some patients also achieved a reduction in disability compared to when they began their participation in the trial.
These results were published last year, but have been presented for the first time at the 59th Annual meeting of the American Academy of Neurology (AAN) in Boston by Dr. Alasdair Coles, (Addenbrooke’s Hospital, University of Cambridge).
Simon Gillespie, Chief Executive of the Society, said: ‘These are preliminary but very encouraging results, especially as they demonstrate a significant improvement on currently available therapies. With the appropriate risk management measures in place, we look forward to the completion of this phase of trialing and the important phase III trial.’
The phase II clinical trial was set up to compare the safety and efficacy of Campath (administered intravenously as a course of injections once a year) with Rebif (administered three times per week by subcutaneous injection). 334 people with early active relapsing remitting MS are taking part.
‘Although several therapies are already available to treat MS, patients still face an unmet need for more effective treatment that further stabilises disability,’ said the principal investigator of the study Prof Alastair Compton, Addenbrooke’s Hospital, University of Cambridge. ‘The large two-year reductions in the risk of relapse and sustained accumulation of disability seen in these interim results are impressive and potentially very encouraging for the many people worldwide who currently face an uncertain future with this devastating disease and for their treating physicians.’
Dosing of Campath in this clinical trial was stopped in September 2005 after three people were diagnosed with immune thrombocytopenic purpura (ITP), a recognised and treatable condition in which low blood platelet counts can lead to abnormal bleeding. An initial case of ITP was fatal. However, five subsequent cases have been successfully treated. Genzyme has since created a comprehensive risk management plan to help physicians and people participating in the trial detect ITP early and minimise the risks of complications.
Other reported side effects of Campath-1H include headache, rash, and fever, temporary worsening of MS symptoms and marginally increased risk of infections. Previous studies have reported around a 30% risk of developing an overactive thyroid, or Graves’ disease, which is a completely treatable condition, but may have serious eye effects in a minority of people. However, results from the most recent study showed a substantial decrease in adverse thyroid related events, with 16% of study participants developing these effects after Campath-1H treatment, compared with 2% after treatment with Rebif.
Two planned phase III clinical trials are expected to begin this year in the US following FDA approval. One trial will include previously untreated people with MS and one will involve people with MS who are receiving an approved therapy, but whose disease remains active.
What is Campath?
Campath® (alemtuzumab) is a humanized monoclonal antibody, that is licensed for the treatment of chronic lymphatic leukaemia. It is thought to have an anti-inflammatory effect in MS. It binds to a specific target on the surface of immune cells and then depletes these cells. Campath has a prolonged action and therefore administration of one dose a year (or even after a longer interval) may be sufficient.
Simon Gillespie, Chief Executive of the Society, said: ‘These are preliminary but very encouraging results, especially as they demonstrate a significant improvement on currently available therapies. With the appropriate risk management measures in place, we look forward to the completion of this phase of trialing and the important phase III trial.’
The phase II clinical trial was set up to compare the safety and efficacy of Campath (administered intravenously as a course of injections once a year) with Rebif (administered three times per week by subcutaneous injection). 334 people with early active relapsing remitting MS are taking part.
‘Although several therapies are already available to treat MS, patients still face an unmet need for more effective treatment that further stabilises disability,’ said the principal investigator of the study Prof Alastair Compton, Addenbrooke’s Hospital, University of Cambridge. ‘The large two-year reductions in the risk of relapse and sustained accumulation of disability seen in these interim results are impressive and potentially very encouraging for the many people worldwide who currently face an uncertain future with this devastating disease and for their treating physicians.’
Dosing of Campath in this clinical trial was stopped in September 2005 after three people were diagnosed with immune thrombocytopenic purpura (ITP), a recognised and treatable condition in which low blood platelet counts can lead to abnormal bleeding. An initial case of ITP was fatal. However, five subsequent cases have been successfully treated. Genzyme has since created a comprehensive risk management plan to help physicians and people participating in the trial detect ITP early and minimise the risks of complications.
Other reported side effects of Campath-1H include headache, rash, and fever, temporary worsening of MS symptoms and marginally increased risk of infections. Previous studies have reported around a 30% risk of developing an overactive thyroid, or Graves’ disease, which is a completely treatable condition, but may have serious eye effects in a minority of people. However, results from the most recent study showed a substantial decrease in adverse thyroid related events, with 16% of study participants developing these effects after Campath-1H treatment, compared with 2% after treatment with Rebif.
Two planned phase III clinical trials are expected to begin this year in the US following FDA approval. One trial will include previously untreated people with MS and one will involve people with MS who are receiving an approved therapy, but whose disease remains active.
What is Campath?
Campath® (alemtuzumab) is a humanized monoclonal antibody, that is licensed for the treatment of chronic lymphatic leukaemia. It is thought to have an anti-inflammatory effect in MS. It binds to a specific target on the surface of immune cells and then depletes these cells. Campath has a prolonged action and therefore administration of one dose a year (or even after a longer interval) may be sufficient.
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