- Citing its lack of progress in convincing regulators to lift the suspension on recruiting patients and the effort involved in retraining and restarting trial sites, Northwest Biotherapeutics (OTCQB:NWBO +0.1%) settles on total enrollment of 331 in its Phase 3 study of DCVax for the treatment of glioblastoma multiforme (brain cancer), 17 short of its target of 348.
- Investigators have been unable to recruit additional subjects after a partial clinical hold was put into place in August 2015. A partial clinical hold suspends new recruitment but allows patients who are already enrolled to continue receiving the study drug.
- The company believes that the current enrollment of 331 will be sufficient to amass the necessary number of events to achieve statistically valid results.