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Re: gr8db8 post# 528

Monday, 12/26/2016 10:43:24 PM

Monday, December 26, 2016 10:43:24 PM

Post# of 2099
Not quite.... IMHO, I believe the dCVax-L phase III(is that northwest?)has had a crazy study with shifting endpoints---pfs to os and numerous other changes and screening halts so who knows? The crazy thing is there are some smart folks who dissent on the opinion that it doesn't work like Larry Smith who I respect, but I would wonder about a trial that takes like 10 years to completely enroll with so many changes in the overall design of the trial.

A better example that would prove your point is the well designed, newly diagnosed GBM trial with the Celldex vaccine. Recall the trial failed to show any difference between placebo and vaccine despite strong phase iI success. The survival was more than any thing ever seen in newly diagnosed with this particular vaccine that the Celldex vaccine was targeting. However, they had very strict inclusion criteria of like 100 % of the tumor(and other criteria) had to be removed with surgery. The problem here is that this led to inclusion criteria that led to the less sick patients being vaccinated or receiving placebo... so though the vaccine didn't work at all, the placebo arms lived more than had been expected. I'm sure the same thing is true for the DCVax as well(probably even more so knowing the history of the Northwest trial.

BTW, this is also true of the much heralded polio vaccine trial featured in 60 minutes and receiving BTD. Yes, the results at first looked great, but there is even stricter inclusion criteria than anything I've ever seen since the polio vaccine can be highly toxic(recall some patients died if they received too much)and also patients who had tumors near the ventricles are being excluded due to risk of toxicity, ext....

Contrast all of these with VBLT... randomized only for age, Karnosky performance, and number of recurrences.... that's it.... So, I don't think you will have patents living that much longer than the historical norm, except with this caveat... I would suspect the standard of care may be a bit better over time if you look at the avastin only arm....so maybe we might see 9-10 months in the placebo arm as opposed to the 8-9 month SOC expectation based on the avastin data for rGBM in prior trials. But, sadly, I can't see what happened in the CLDX GBM trial where there was a huge improvement.

BTW, I believe the polio vaccine may work in the right patient with the right immune system... much like VB-111.

If "it" works, my guess would be an interim analysis mid year--but maybe skewed a few months later.
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