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GlaxoSmithKline and Genmab initiate ofatumumab rheumatoid arthritis Phase III programme


London, UK - GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced today the initiation of the Phase III programme with ofatumumab to treat rheumatoid arthritis (RA). The programme will commence with two studies (OFA110635/GEN410 and OFA110634/GEN411), which will be conducted outside the US, in two distinct patient populations. One study will be in patients who have had an inadequate response to methotrexate therapy; and the other in patients who have had an inadequate response to TNF-alpha antagonist therapy. Further studies to support the programme are planned for 2008.

Each study will evaluate the efficacy of ofatumumab in reducing the clinical signs and symptoms in RA patients after a single course of ofatumumab and comprises of a 24 week blinded period followed by a 120 week open-label period during which re-treatment will be studied. The primary endpoint in each study is ACR20 at 24 weeks.

“This brings us closer to our goal of broadening the treatment options for patients with this painful and debilitating disease” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. “From the data to date, we believe that ofatumumab has real potential. Now that Phase 3 studies are underway in multiple indications we are moving closer to realising this potential and bringing this important treatment to patients.”

“We are very pleased that our collaboration with Genmab has progressed so that we can now move to the next step of the clinical trial programme,” said Dr Moncef Slaoui, Chairman of Research and Development, GlaxoSmithKline.

Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells. This epitope is different than other anti-CD20 antibodies currently available or in development.


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