Six-Month Zenapax Data; Global Filing Set For 1H97

With new positive results in from two Phase III multinational trials ofZenapax (dacliximab), an anti-TAC monoclonal antibody for the prevention of transplant rejection, licensee Hoffmann-La Roche plans to file for approval in the USA, Canada and Europe in first-half 1997.

Zenapax was developed by Protein Design Labs, and could be on the market by 1998. It is indicated in the first instance for the prevention of acute graft rejection in kidney transplant recipients, although later indications in other solid organ transplants will surely follow.

New Data On February 15, new six-month mortality and graft survival data from the two Phase III studies were presented at a meeting of the American Society of Transplant Physicians by Flavio Vincenti, a principal investigator in one of the studies.