Phase III Results With Novartis' Basiliximab

A Phase III trial of Novartis' anti-CD25 chimeric monoclonal antibodySimulect (basiliximab) has found that the drug significantly reduced the incidence of acute rejection episodes in renal allograft recipients. The data were reported in The Lancet (October 25 issue).

With current therapies, acute rejection occurs in about 30%-50% of patients. In this trial, 380 primary cadaveric kidney transplant patients were randomized to receive either placebo or a 20mg/30 minute infusion of basiliximab on the day of surgery (about two hours before transplantation) and on day four.

Because basiliximab has a long half-life, two infusions will provide interleukin-2 receptor suppression for four to six weeks, according to the company. Both groups were co-administered with Novartis' Neoral (ciclosporin) and prednisolone from baseline.