Replies to post #21820 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

This happened back when DCVax-L was very young, and due to the success they were having, they went back to the FDA to ask that extended treatment be allowed.

Fairly recently, I think it was Bosch said patients could keep taking Direct boosters for the rest of their life if they needed to.

Unless I missed it, this is a question that would be helpful to get an answer to for the phase two multiple injection per procedure DCVax-Direct trial starting this fall.


General Thoughts of late.

(In the phase I Direct trial, if a certain percentage of patients demonstrate complete remission by the 6th injection, no alternative medical treatment would necessarily be needed for them -- except perhaps Direct boosters.)

(Note: the 4th, 5th and 6th injections are considered mandatory "boosters." This is very intriguing IMHO.)

(That OHSU study also gave us insight that really great results can happen to patients still demonstrating pseudo progression beyond 3 months. 3 months is in between the third and fourth injections, so I would think researchers would be encouraged where they are still seeing pseudo progression in some patients after the 4th injection. Of course, pseudo-progression is not necessary in every successfully responding patient. )

[Pyrrhonian]

I dislike the idea that this would then make if very difficult to discern the effectiveness of DCVax-Direct on a standalone basis.--Eval

Not exactly what I said. The effect of therapy will clearly be seen in both the Ph I and II leg. However, should a patient enroll in a checkpoint inhibitor trial (there are many cropping up), after receiving their 6th injection, it will likely skew long term data. Imo it would be to the positive. And I think management will conveniently leave that part out, should this happen: "28/40 still alive after 24 months."

Anyway, things like that happen all the time in clinical trials. There will be a number of patients who don't enroll in further trials, and comparisons can be drawn between them and those that do. It's a good thing. It will result in better therapies down the road. But the thing I'm saying is, should a synergistic effect take place between this DC vaccine and checkpoint inhibitors, as Dr. Black and others opined would occur, then that will only enhance the case for DCVax-Direct.

what do you currently estimate the odds that Direct could be the full solution .... whereby patients do not need to go enroll in another clinical trial afterwards?--Eval

Um.. with a single injection, 0%. With multiple, 20%. You realize this is absolute speculation on my part of course (let me guess flipper's percentages--single, 48%; multiple, 96% ;D). However, you did say "full solution," which I take to mean only forward progress towards remission. Really, nothing does that today. If Direct can show that it has the ability to increase multiple patient's QoL, PFS, and especially OS, in a clinically meaningful way, then nothing will stop its path to approval. In other words, it doesn't have to even DO very much to become a blockbuster. Keep in mind there are no therapies for these patients. And consider how minor an increase in OS Temodar had in GBM patients (2.6 mo), but how much of a blockbuster it was and is.

I suspect that if NWBO concludes that it would be beneficial or synergistic to explore combination therapies ... then it would be like starting all over at the beginning of a new phase I trial to test the combination? In that instance would the Direct trial continue on a standalone basis?--Eval

No, not really. If Direct gets approval they can conduct one large combination immunotherapy trial and submit its results for label extension. Look up, for instance, how many trials an established pharma like BAX has going on ALL THE TIME... If DCVax gets regulatory approval expect all kinds of trials to crop up.