Summary
- NWBO has run an 18-year long trial in GBM, one of the deadliest of cancers.
- It has been mired in controversies, and it has no cash.
- Its trial data has been locked, and will be blinded, hopefully in a short while.
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I wrote a piece on Northwest Bio (OTCQB:NWBO) on Nov. 27, 2018, where I said I expected them to unblind their phase 3 glioblastoma trial of DCVax-L “in another few months.” I also said it was a battleground stock, fiercely fought over by street bulls and bears, with allegations and counter allegations and even the FBI thrown in.
The entire 2019 passed, and not a single article was written about NWBO on Seeking Alpha, possibly because the trial was never unblinded. Then a few articles were written in 2020, but the data was still not unblinded.
Finally, on Oct. 5, 2020, NWBO declared that data from the phase 3 study has been locked. That means data will now finally be unblinded for statisticians working on the trial:
With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.
So, while we still do not know when we, the investors, will be able to see this data, this is progress. In an earlier press release, NWBO suggested that “within a couple of weeks” of submission the statisticians should complete their work. “Only then will the company be unblinded to the data.”
What took so long?
If you recall from your study of this company, they were waiting for the 233rd death to occur out of 331 patients to calculate whether DCVax-L has any survival benefit. That event took much longer than anticipated, and was the reason for the delay.
Let me go back and recapitulate everything in the clearest language possible for everyone.
The DCVax-L story
The DCVax-L trial was started 18 years ago as a phase 2 trial that morphed into a phase 3 trial. This is an immunotherapy vaccine that's targeting glioblastoma, the deadliest of all cancers, where 100s of trials have failed.
The trial had 331 patients in all, and its design was such that 67% of all patients were to receive DCVax-L after initial standard of care, which was originally radiation and Temodar therapy, but also later included Optune. This number was later to become 90% of all patients receiving DCVax-L because of the following provision of the trial:
Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm upon documented disease progression.
These sorts of trials in high-risk diseases are supposed to do interim analysis to see if the drug has any treatment benefit or if the patients are at risk of wasting valuable time by taking it. The trial could be stopped midway for two reasons - obvious treatment benefit, in which case it makes no ethical sense to deprive placebo-receivers or others of the drug, or obvious lack of benefit, in which case it makes no sense to let drug-arm subjects continue with what amounts to a wasteful effort.
