NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Interesting Long!

Further thought: if the PhII adjuvant trial shows positive effects from the adjuvants, this could perhaps be put into the -Direct PhII protocol.

The timing is right, with the adjuvant PhII yielding results Q4 this year, and the first of the -Direct PhII's possibly starting 1H 2015, and almost certainly by 2H 2015. --Long

I'm not certain this would happen in the "seamless" continuation into phase 2 Direct trial LP discussed, but I think it might be possible to run it in a separate parallel phase 2b. (As you know, we already had one (likely small) phase 2 run at UCLA.)

If they run 2.5 (total) adjuvants** side by side in phase 2b DCVax-Direct trials, a non-responder (informational) arm could be established to try the same treatment with one of the other adjuvants. Even partial responders could take advantage of this. Where their immune system inflammation response curtails over time, a new separate adjuvant might be used to restimulate the dendritic cell efficacy. The non/partial-reponder arms could be in the same or different trials.

The reason something like this can be done (aka: adaptive treatment protocol) is because OS is not the primary endpoint.

**I use the term adjuvant loosely here, because the original L and Direct use the adjuvant exvivo, and thus it is already incorporated into the DC Cell prior to injection. The other 2 adjuvants are actually used directly -- alongside DCVax -- in vivo.