Sep 13 2010
Genmab A/S (Copenhagen:GEN) announced today encouraging results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis (RRMS).
A total of 38 patients were included in this double-blind, dose escalation trial. Patients were randomized to receive two infusions of 100 mg, 300 mg or 700 mg of ofatumumab or placebo. After 24 weeks, the patients randomized to placebo were treated with ofatumumab and patients who were treated with ofatumumab received placebo. All patients were then followed for an additional 24 weeks.
In the study, there were no dose limiting toxicities, no unexpected safety findings, and no patients tested positive for human anti-human antibodies. Efficacy was assessed by MRI (magnetic resonance imaging) as a secondary endpoint. Repeated MRI scans showed a sustained reduction in the number of brain lesions up to week 48 in patients>
Study links initial symptoms to long-term disability in multiple sclerosis