COPENHAGEN, Denmark; April 25, 2007 - Genmab A/S (CSE: GEN) announced today that the results of a Phase II study with ofatumumab (HuMax-CD20™) in patients with rheumatoid arthritis (RA) have been accepted for oral presentation at the 2007 Annual European Congress of Rheumatology (EULAR). The oral presentation, which will include new results from the double-blind, placebo controlled Phase II study with ofatumumab, along with data from the previous interim analysis, will be described by Professor Mikkel Østergaard, Department of Rheumatology, Copenhagen University Hospital on June 16, 2007. The abstract for the presentation will be available at www.eular.org in mid-May.
Genmab A/S and GlaxoSmithKline have a worldwide agreement to co-develop and commercialize ofatumumab.
About the study
A total of 226 patients with active RA who have previously
failed one or more disease-modifying anti-rheumatic drugs (DMARDs)
were enrolled in the Phase II study. Patients were randomized to
one of 4 treatment groups (300 mg, 700 mg or 1000 mg of ofatumumab
or placebo). Patients were permitted to continue therapy with
stable doses of methotrexate and low dose prednisolone. ACR and
EULAR responses were assessed in the primary intention-to-treat
efficacy population at 24 weeks.