A team of researchers funded by Arthritis Research UK and GlaxoSmithKline are setting up a multicenter Phase I study of a targeted T-cell anti-CD3 monoclonal antibody therapy known as otelixizumab as a treatment for rheumatoid arthritis. And the scientists hope that the therapy, which also is in Phase III testing for autoimmune Type 1 diabetes, will be able to "switch off" the debilitating disease.
CD3 is a molecule found on the surface of T-cells and is important in stimulating the them into action. Otelixuzumab works by latching onto the T-cells, potentially switching them off and increasing regulatory cells that control inflammation. Researchers are betting that otelixizumab will be as effective in reducing symptoms as the current standard therapy for severe RA, but will have a more sustained effect from just a one-off one course of treatment.
"Everything we know about this drug suggests that it has the potential to be a powerful treatment," Professor John Isaacs from Newcastle University's Musculoskeletal Research Group who will lead the study says in an Arthritis UK statement. He adds that the researchers hope to demonstrate the safety of the drug with the study. If the drug was shown to be safe and effective in subsequent Phase II and III trials, it could be available for RA patients in eight to 10 years, Isaacs says.
In an important aspect of the study, researchers from Newcastle University and King's College London, will also be performing laboratory studies aimed at identifying and analyzing potential biomarkers in the blood that might predict whether or not a patient will have a sustained response to the therapy.
GSK formed an alliance with Tolerx in 2007 to develop the drug.
- see the Arthritis UK statement