Phase III Results With IMTIX' Antirejection Antibody

IMTIX, the transplant division of Pasteur Merieux Connaught, hasreported positive Phase III results from a European study of odulimomab in cadaveric kidney transplant patients. The monoclonal antibody was shown to improve early graft function when added to the induction phase of standard immunosuppressive triple therapy.

The product is a murine monoclonal antibody targeted at cd11a, the alfa chain of leukocyte function-associated antigen-1. LFA-1 is associated with leukocyte adhesion during cellular interactions for immunological responses and inflammation. In the transplant setting, the antibody is thought to prevent lymphocyte binding to the allograft, as well as reducing neutrophil-mediated damage once the transplant is reperfused. Animal data suggest that the antibody achieves a selective deficit in the induction of peripheral immune responses, while allowing normal responses to systemic infections.

Odulimomab was given by intravenous injection in a 30mg loading dose, followed by daily injections of 15mg/day on days one to nine. Novartis' Neoral (ciclosporin) was given from day one, along with Glaxo Wellcome's Imuran (azathioprine) and corticosteroids. The control group received ciclosporin, azathioprine and corticosteroids alone.