NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

If you’re going to do estimates as to how many patients were in the main arm or information arm of the trial at any given time, and use the German Label to support it, you really should at least download a copy and translate it for your files. It’s been posted many times and can be accessed on line with a simple google search.

Here is the link… you will have to translate it.

http://portal.dimdi.de/amispb/doc/pei/Web/2613044-palde-20140601.pdf

Under:

The data on the safety of the drug
In two completed Phase I / II clinical trials and an ongoing phase III study with a total of 103 patients with glioblastoma total of 70 adverse events have been reported in association with treatment with DCVax-L (in 12 patients in the Phase I / II study no. 8434, 18 patients in the phase I / II study no. 11053 [ in mid 2012]; see Table 1). Of these adverse events were not serious. The majority of adverse reactions associated with DCVax-L were mild to moderate in severity, only two cases of headache was of severe. There were no serious adverse events (AEs) with possible causal relationship to DCVax-L-therapy.

and under

Phamacodynamic Properties:
Two clinical studies were conducted in the US in order to assess the safety and efficacy of intradermal administered DCVax-L for a total of 40 patients with malignant glioma, 22 of them newly diagnosed GBM (glioblastoma multiforme), 13 a recurrent GBM and 5 patients low grade malignant gliomas had.

Study No. 8434:. The primary endpoint was to determine the maximum tolerated dose (maximum tolerated dose (MTD)) on the dose-limiting toxicity (dose limiting toxicity (DLT)). Secondary endpoints included progression-free survival (progression-free survival (PFS)) as well as monitoring the humoral and cellular immune response.

Study # 11053:. The primary objective was to determine the dose-limiting toxicity (DLT) in the planned dosing schedule. Given intradermal injections of 3 different doses (1 × 106, 5 × 106,
10 × 106 cells / injection) administered which dendritic cells from autologous

and under

Newly diagnosed glioblastoma
22 adults with newly diagnosed Gliobastoma were treated after previous surgical removal of the tumor and radiation therapy with concomitant chemotherapy with DCVax-L injections. The median survival of the patients was 35 months. The median progression-free survival (PFS) was 23.1 months. The progression-free survival at 36 months was on average 34% (13% - 55%).

and finally

The study 020221 is an ongoing Phase III trial. At the time August 15, 2012 increased 41 hospitals in the United States participated in the study and 84 GBM patients were included. Of these 84 patients 49 were included in the primary study cohort randomized (2: 1, active drug versus placebo), and 35 patients were enrolled in an open-label arm of the study, which is designed specifically for patients with rapid tumor progression.

RK says...

Right, Rapids are included, rGBM is not.

No, once again, you are wrong. Recurrent GBM is included in the safety numbers. I laid this out earlier today in a past post, but you must not have read it. So once again, you are in error… any recurrent GBM patient that received DCVax IS counted in the safety numbers.

RK says...

Again my focus was not on where enrollment was at. It was on the 33. No matter, it's only 4, Rapids would be part that 11 patients. I can't change SEC numbers. But I see now why you're so resistant to it.

You are right, I am resistant to it. On top of that, I don’t even know what you are trying to say here. That there were 4 rapids who were part of the 11 in the trial as of November 2008? If that's it, I don’t even see what the relevance of that is.

On the safety of the drug, there are 103 GBM patients. I posted this earlier today.
They are sorted like this:

22 newly diagnosed GBM patients from two P1s
13 recurrent GBM (can’t count the additional 5 patients with gliomas)
35 open label rapid progressor GBM
33 two/thirds or the randomized treatment portion from the 49 patients in the actual trial

= 103 patients indicated in the safety of the drug

Those 22 newly diagnosed GBM and recurrent GBM patients come from two trials: NCT00612001, and NCT00068510… where they were all treated in a variety of different combinations resulting in I believe, at least three abstracts.

From the data as presented in this German Label, it suggests strongly that by August 2012, there were 49 enrolled and randomized in the main arm of the trial.

So, as you have pointed out, the 10-Q filed on August 19, 2008 shows they had only 6 patients enrolled. Were those 6 patients randomized into the trial, or al or some put into the info arm? I don't think we can know, and I suggest you simply don’t either. Same with the 11 noted in November 2008.

What is stated by the German Label, is that 49 patients were enrolled in the trial as of August 2012. So if one accepts its veracity, and it seems to me to have credibility, than one can accept that figure may be as close as one can come to determining what the main arm enrollment was at that time.


You still haven’t proven where they have been misleading or lied. I would suggest, however, that your post, while you are not intending to be misleading, is fraught with errors, and in being so, is also misleading. It's a bit like the pot calling the kettle black.

As I wrote earlier, it is highly unlikely that the 17 you suggest who came into from the Overlook and/or NYU all went into the 35 information arm containing what were supposed to be rapid progressors, and that only three went into the trial. That ratio just doesn't jive.

I also showed in my prior post, that Bob Gibbs could very well have been enrolled in this trial if he were enrolled in May 2008 (you stated that time for enrollment… I haven’t checked it) because May 2008 is when the clinical trials history shows the double blind trial began, and it shows UCLA had been recruiting patients since March 20, 2007.

It’s a good DD to look at the SEC files… but before you go suggesting the company is being misleading, I suggest you look more carefully the other documents you are citing (the German Label), and at the clinical trials history as well, to see if whatever you are suggesting, might be in fact, wrong.