BETHESDA, Md., August 19, 2020 – Northwest Biotherapeutics (OTCQB: NWBO)(“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the remaining outstanding clinical trial data for the Company’s Phase 3 trial of DCVax®-L for Glioblastoma brain cancer as described in the Company’s last report on July 24, 2020 has now been completed by the specialty analytics firms. With this data now in hand, final quality control checking and confirmation are under way to enable Data Lock.
This further data involves specialty analytics such as genomic profiling for IDH mutations and certain imaging. The independent CRO managing the trial is now integrating this data into the overall trial database containing the clinical data from the trial sites that was already complete and locked as reported on July 24, 2020, in order to complete the overall trial dataset.
When Data Lock is reached, the independent statisticians will be given access to the unblinded dataset. The Company will remain blinded while the statisticians make the computations, converting the mass of raw data from the trial into formal tables and listings, and survival and progression measures, to report the trial results.
As previously reported, the statisticians’ work is estimated to take a couple of weeks. When their computations are completed, the Company will receive the results of those computations and thereby become unblinded. It is anticipated that the Company’s Scientific Advisory Board, the Steering Committee of the Trial and other key medical expert advisors will likewise receive the results, and thereby become unblinded as well.
The Company currently continues to anticipate reporting topline trial data in September, and anticipates providing further updates as the process progresses.