FDAnews
www.fdanews.com/articles/68259-nwbt-to-initiate-phase-iii-trial-for-prostate-cancer

NWBT to Initiate Phase III Trial for Prostate Cancer

February 2, 2005

Northwest Biotherapeutics (NWBT) has received clearance from the FDA to begin assessment of its cell-based dendritic cell product candidate, DCVax-Prostate, in a Phase III clinical trial.

This trial is based on promising clinical data from a previously conducted Phase I/II clinical trial. The double-blinded, placebo-controlled, Phase III clinical trial is expected to enroll roughly 600 patients at 30 to 50 sites throughout the U.S.

Northwest Biotherapeutics previously received clearance through the FDA for a Phase II clinical trial for DCVax-Brain, a promising new treatment for Glioblastoma Multiforme which is the most common, and lethal form of brain cancer. The company intends to begin this multisite clinical trial later this year. In addition, the DCVax platform can be used for multiple cancer indications, and NWBT has completed preclinical work targeted for a Phase I clinical trial for non-small cell lung cancer and head and neck cancer.