Zenapax Results Boost PDL And Roche

The results of two multinational Phase III trials evaluating Protein Design Labs' Zenapax (dacliximab) for the prevention of acute graft rejection in kidney transplant recipients indicate that the antibody is effective in reducing the incidence of acute rejection episodes when administered with a standard immunosuppressive regimen.

Based on these trials, in the first half of 1997 PDL's development partner Roche intends to file for marketing clearance for Zenapax for this indication in the USA, Canada and Europe.

Two Phase III trials were conducted. In the double-therapy trial, in which all patients received ciclosporin and prednisone, acute rejection episodes were reduced by 40% in patients treated with Zenapax. In the triple-therapy trial, where all patients received ciclosporin, prednisone and azathioprine, acute rejection episodes were reduced by 37% in patients treated with Zenapax. No clinically significant adverse events attributed to Zenapax were observed, according to a preliminary analysis of these data.