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Saturday, October 14, 2006
CAMPATH (alemtuzumab) Editorial by the UK Multiple Sclerosis Society
The (UK) Multiple Sclerosis Society has welcomed the interim results of a phase II trial of Campath (alemtuzumab).
They show that people with MS 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.
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 trialling 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.
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 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, Genzyme reports that incidents of all thyroid-related adverse events, including Graves’ disease, were less than expected.
Genzyme is expected to initiate a phase III clinical trial with Campath early in 2007.
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.
The (UK) Multiple Sclerosis Society has welcomed the interim results of a phase II trial of Campath (alemtuzumab).
They show that people with MS 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.
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 trialling 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.
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 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, Genzyme reports that incidents of all thyroid-related adverse events, including Graves’ disease, were less than expected.
Genzyme is expected to initiate a phase III clinical trial with Campath early in 2007.
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.