Replies to post #212725 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

That-was-IMUC's-phase-I-16-patient-trial-ICI. Unblinded.

You are literally comparing a phase III blinded trial (DCVax-L) to a phase I unblinded (aka: never blinded) trial (ICT-107). You might want to rethink that. Or maybe it suits you just fine.

Furthermore, you don't know if the results of the DCVax-L trial will be confounded or not when they compare arms. If you do, you have insider information.

Furthermore, it is randomized at 2.34:1, albeit, not perfect, but I suppose regulators already know that.

[longfellow95]

Problem is, no clue if it had anything to do with the actual treatment. Just like NWBO.

I would suggest it is to to do with treatment.
Because you just do not get anything like those stats with SOC.

Merck has no problems getting approvals from small uncontrolled single-arm open-label trials that say more about toxicity than they do about survival.

There is little correlation between whether a drug works or not, and whether it is safe or toxic, and whether it is approved!

But that's the good old FDA for you...

If DCVaxL fails to gain approval, it won't be because it doesn't work.

Just my humble opinion.

[survivor1x]

" and expression of four ICT-107 targeted antigens in pre-immunotherapy tumors correlated with prolonged OS and PFS in GBM patients"

This kind of plays well into the WTL and the beauty of targeted personalized medicine. The more (Targets) expressed, that matched ICT's "pre-selected" targets , the greater the outcome. That is the problem in treating a heterogeneous population with the same drug and expecting it to work for everyone. We have to get better at treating an individuals disease.


Just think if Eye Doctors where like Oncologists, When you go to the eye doctor, they don't just say yep you can't see perfectly(have breast cancer) and here take these same prescriptions lenses(monoclonal antibody or checkpoint) we gave the last person, we saved money by buying a boatload of the same prescription glasses in bulk. They seem to work really well for about 15% of the population.


DCVAX matches treatment to patient. It's not perfect but it is an important first step.

[Extremist223]

I guess you should be upset then that your tax dollars are being thrown down the drain as grant money to these researchers. Dcvax is working maybe you see the light.

[abeta]

OMG - Adam wrong TWICE?

AND IN just __ONE__ story .......

Is that your point?

Thanks for pointing that out. But I'n not surprised. Figures

Adam Feuerstein aside - can't wait to see the dynamic combination
of VAX and mesenchymal.

[CherryTree1]

The ICT-107 P1 paper you reference was published in 2016. Things have changed with the FDA. I posed this last week, FDA Director's speech from this past June. Perhaps you missed it:
https://www.fda.gov/NewsEvents/Speeches/ucm611623.htm

Remarks by Dr. Gottlieb to the National Comprehensive Cancer Network Policy Summit
Pivotal trials testing these products are also likely to have crossover designs, meaning that if a patient’s cancer grows on the comparator treatment, then the patient is switched over to the experimental arm. Both arms receive the experimental drug, although in different sequence. Statistically, this may make it difficult to show an overall survival advantage for the experimental arm. Patients aren’t left on the comparator arm for long enough to show that they would have died sooner if left off the new drug. There’s a simple bottom line here. When new drug shows a robust effect on things like tumor size or tumor progression, patients are understandably less willing to forgo a new therapy in the name of a good “p” value.

It is worth taking the time to read the whole speech, very relevant to DCVAX.

[GoodGuyBill]

ICLight,

Why did the trial fail? Was there adequate separation between control & treatment?

What did IMUC use as the placebo in the trial?

What is NWBO using as the placebo for their Trail?

Why are you comparing the IMUC trial with NWBO's trial?