DSMB recommends continuation of Phase III Vicinium trial in NMIBC

Eleven Biotherapeutics Inc. (NASDAQ:EBIO) said an independent DSMB recommended continuation of its Phase III trial evaluating Vicinium (VB4-845) via intravesical instillation to treat high-grade non-muscle invasive bladder cancer (NMIBC) patients who previously failed treatment with bacillus Calmette-Guérin (BCG) with or without interferon. The DSMB based its decision on safety and efficacy data and did not recommend any modifications for the trial, which has enrolled over half of a planned 134 patients.

The open-label, North American trial is evaluating 30 mg Vicinium twice weekly for 6 weeks followed by once weekly for 6 weeks in an induction phase, then 30 mg Vicinium every 2 weeks for up to 21 monthly cycles in a maintenance phase. ...