Aeterna's selective use of surrogates

The ideal use of a surrogate marker in cancer is to support the accelerated approval of a new therapeutic more rapidly than could be accomplished using hard clinical end points. Although Aeterna Laboratories Inc. is using clinical end points in two pivotal trials of its Neovastat oral angiogenesis inhibitor, it has decided that in a third cancer, a surrogate marker makes more sense.

In RCC, Aeterna (TSE:AEL; AELA, Quebec City, Quebec) is running an international 270-patient Phase III trial that will assess median survival time as its primary end point. Enrollment is expected to take 12 months and the trial is expected to be completed in two years (see BioCentury, May 8, 2000)...