DETAILS OF 2nd Phase III CENTOXIN TRIAL

Centocor has released details of the second Phase III trial of its monoclonal antibody sepsis drug, Centoxin (HA-1A), which will aim to produce data that will overcome the shortcomings of the New Drug Application dossier which was rejected by the US Food and Drug Administration recently (Marketletter April 27). The new study, which received approval from the FDA on June 3, will look at 14-day sepsis mortal-ity as its primary end-point.

According to the FDA, the deficiencies in the data from the first trial centered on a change mid-way through the protocol to make the primary endpoint 28-day mortality. The agency notes that during the 28-day period a marginal statistical difference in mortality was demonstrated between HA-1A-treated and placebo-treated patients, but there was no statistical significance in survival at 14 days.

Centocor's main rival in the monoclonal antibody sepsis treatment bracket, Xoma, has experienced problems of its own, with the FDA also insisting that it carry out another efficacy trial on its Xomen-E5 product (see page 7).