GSK and Genmab present positive ofatumumab phase II results

GlaxoSmithKline (GSK) and Genmab have announced positive results of a phase II clinical study assessing the use of HuMax-CD20 (ofatumumab) in patients with rheumatoid arthritis.

These results are to be presented at the annual meeting of the European League Against Rheumatism (EULAR) being held in Barcelona from June 13th-16th 2007.

Patients in the trial had previously failed one or more treatment regimens with disease-modifying anti-rheumatic drugs for their active rheumatoid arthritis, with the 225 participants treated with placebo or 300 mg, 700 mg or 1,000 mg of ofatumumab.

GSK and Genmab are currently co-developing the fully human monoclonal antibody following the signing of a global agreement between the firms.

Dr Kathy Rouan, vice-president of research and development at GSK, stated that these trial results were a key landmark in the development of ofatumumab.

“They will enable us to progress development in the rheumatoid arthritis indication and help bring this potentially important treatment to patients suffering from this often painful and debilitating condition,” she said.

GSK signed a deal with Genmab for the development and marketing of the drug in December 2006, with GSK paying an initial fee of DKK 582 million (52 million pounds) to license the compound, in addition to purchasing 4,471,202 ordinary shares in the company for DKK 2033 million.