Replies to post #96959 on NorthWest Biotherapeutics Inc (NWBO)

[Smokey21]

Also am I correct that this is the same horrible disease that was mentioned in the recent movie Collateral Beauty with Will Smith, Kate Winslet, Helen Mirren, and Ed Norton. They definitely mentioned GMB numerous times! Best wishes.

Here is your answer:
http://www.missioalliance.org/collateral-beauty-and-the-question-of-suffering/

[flipper44]

Crossover almost by definition causes some level of confoundment. There are reasons to believe confoundment may not be as strong here. The latest one relates to the recent recurrent trial design where no temodar is used. When a patient only gets temador after chemo-radiation, their lymphocyte count typically goes down. If you have temodar+ DC therapy, the lymphocyte may not be negatively affected to as critical of a degree. However, getting someone's lymphocyte count back up after long chemo treatment may be difficult. This may put placebos in the current trial at a disadvantage -- maybe, and possibly why the new recurrent trial does not use Temador. Anyway, there are many considerations. IMHO

There are also reasons to think there may be confoundment to some degree, because the principal investigator is seeing what seems to her as all the people in the trial living longer than expected. This may not in fact be "all" the patients, because some patients left the trial and started other trials or therapies. IMHO

You have to look at everything very closely.

[Doc logic]

Sparky277,

I am not sure about the movie but if you meant GBM instead of GMB, then yes this is the same disease.

As far as crossover patients go, they will do the best they can to quantify overall survival benefit differences between any patients that never did cross over to receive DCVax-L from SOC, those that received DCVax-L only at crossover from SOC, those that received regular treatment regimen only and those that received treatment and then crossed over to restart treatment. All treatments stop by the time 3 years have passed per protocol.

The recently announced Phase 2 combination trial looks to further quantify benefit of treatment alone vs treatment plus a checkpoint inhibitor in the recurrent GBM population that has not previously been treated with either checkpoint inhibitors or other immunotherapy like DCVax-L. The small size of this trial plus involvement from NIH makes me think it is for something like a label extension or confirmation of a very high probability effect. SOC is not being used as a comparator which is highly unusual in any trial utilizing a treatment that is not yet approved by any regulatory body. Best wishes.