Genmab Announces Results of Ofatumumab Phase II Study in Multiple Sclerosis
Copenhagen, Denmark; September 10, 2010 – Genmab A/S (OMX: 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 (n=26) who were treated with ofatumumab followed by placebo. Patients who received placebo followed by ofatumumab (n=12) showed similar 24 week results to those who were treated with ofatumumab followed by placebo.
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system. MS is twice as common in females as in males, occurs with a peak incidence at the age of 35 years and incidence varies widely in different populations and ethnic groups. The etiology of MS remains unknown, but the geographic variation points towards possible environmental and genetic factors. The most common form of MS is relapsing-remitting MS characterized by unpredictable recurrent attacks where the symptoms usually evolve over days and are followed by either complete, partial or no neurological recovery. No progression of neurological impairment is experienced between attacks.
Ofatumumab is a novel human monoclonal antibody. It targets a part of the CD20 molecule on B-cells encompassing an epitope in the small loop.
Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. Ofatumumab is not yet approved in any country for RRMS.
Posted: September 2010