Although a small trial, impressive phase 1 trial results for DCvax-Direct for multiple solid tumor cancers:
Over 5 years ago. And the secondary efficacy endpoint (response rate) came in at 0.
It was also designed as a P1/2 trial. They planned to enroll an additional 20 patients on the P2 phase in whichever indication showed the most promise. Never happened.
Since then NWBO has made numerous announcements of subsequent Direct trials ready to start. Various vague statements of the P2 phase of the P1/2. Then in 2017 ASCO a P2 in sarcoma was all set to go in a few months. And then in 2018 ASCO two more trials soon. One already set to launch and the other finalizing the IND.
Crickets.
The apologists will chirp in that RR does not matter. For approval, somewhat true. But it is used early to see if treatments are promising. And it was what NWBO chose.
On the trials not strating, they will say NWBO did not have the cash. But then why keep hyping them year after year, and even paying Cognate $1M to spin up Direct manufacturing?
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