AP News – October 15, 2010
NEW YORK
Drugmakers Roche and Biogen Idec Inc. said Friday that their drug candidate ocrelizumab met its goal in a mid-stage clinical trial, as it reduced brain lesions associated with multiple sclerosis compared to placebo.
The companies said that compared to placebo, patients who took a low dose of ocrelizumab had 89 percent fewer brain lesions, and patients who took a larger dose had 96 percent fewer lesions. Patients on ocrelizumab also had a larger reduction in flare-ups of their symptoms. The study lasted 24 weeks and involved 220 patients. The patients who were treated with ocrelizumab were given infusions at the start of the trial, and then a second infusion two weeks later.
Biogen is developing the drug in a partnership with Roche’s Genentech unit. The companies also studied ocrelizumab as a treatment for rheumatoid arthritis, but stopped studies in March and discontinued the research in May.
Multiple sclerosis is a disease in which the immune system attacks healthy nerves. It can cause pain, numbness, slurred speech, impaired vision, muscle weakness, and neurological problems. The companies said about 1.3 million people worldwide have the disease.
Brain lesions were detected with MRI scans of the patients’ brains. One patient who was treated with the higher dose of ocrelizumab died of a systemic acute inflammatory reaction. The companies said it is not clear if the drug caused that reaction. Side effects included hypersensitivity, inflammatory responses, and squamous cell carcinoma of the skin in a patient with a pre-existing lesion.
The companies will continue treating patients for up to 96 weeks, getting infusions every 24 weeks.
Article Source: Business week
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