Replies to post #623277 on NorthWest Biotherapeutics Inc (NWBO)

[dstock07734]

Thanks, beartrap.

I never get tired of repeating the facts on this combo trial. The regimen for one of the toughest cancer if not the toughest is three-doses the vaccine followed by poly-iclc within 28 days. Five out of nine patients live over ten years. Is that an amazing miracle? But Dr. Liau only published the results as an abstract.

https://classic.clinicaltrials.gov/ct2/show/NCT01204684?spons=Jonsson&draw=3

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6216157/
https://academic.oup.com/neuro-oncology/article/22/Supplement_2/ii36/5960562

[Red_Right_Hand]

Beartrap, to your point, the P2 polyICLC combo trial (NCT01204684) set out to enroll 60 patients, with the goal of measuring "Time to tumor progression and overall survival" over a 2-year period.

In January 2015, the Overall Status was changed from Recruiting -> Active, Not Recruiting. So if they stopped Recruiting in 2015, and they intended to follow patients for a 2-year period after treatment, why is the Primary Completion Date listed as January 2024 (i.e, 5 months from now)? It would seem the planned 2-year follow-up from the last recruited patient would've been completed no later than sometime in 2018. Or are they waiting for the OS tail to mature beyond the 2-year follow-up?

They'd be beyond 5 years from final patient recruitment at this point.

[Doc logic]

beartrap12,

Even with small numbers the statistical significance is awesome and very eye catching. It’s also pretty obvious people are going to get this whether approved by FDA or other regulators or not. The cat is out of the bag and networks of support groups will spread the news. Regulators will lose respect and be called into question openly if they get in the way. There are plenty of nearby countries with much less restrictive access to drug treatments. Best wishes.

[exwannabe]

For those who don't know: UCLA and Dr. Linda Liau have run a clinical trial with DCVax-L and poly-ICLC, which is Hiltonol, since 2010.

No, I don't know. Perhaps you are confused with this trial?

Anyway, results on 23 of the 60 patients have been published. Still waiting on the full results.

The initial results with only 23 across 3 arms in mixed gliomas is not very robust. Switch just a few of the lower grade gliomas between arms and a very different story. When we see the full data, along with the grade 3 vs 4 breakdown we will have a better idea.

Regardless,if A+B is better that A that shows something good for B. By itself shows nothing about A.

Maybe results this SNO? Maybe a few more years? I would bet on the early data being heavily chance. We shall see.