So, with all these things in mind, if one goes back to slide 11 from Dr. Bosch's ASCO 2015 presentation, they'll see that far more patients achieve stabilization with method B at 8 weeks.
Method A = 25% (4 people) achieved SD at 8 weeks
Method B = 84% (16 people) achieved SD at 8 weeks.
As I said in my related post, it appears only people who achieved stable disease are still alive (not all of them, but no PD are alive). Therefore most of those SD are method B.
However, even all of those patients did not receive superior dosing levels, frequency and perhaps number of doses because of various reasons, including possible false progression.
Moving Forward:
So we still have method B patients that can be stabilized at 8 weeks comprising almost all the patients alive today.
Still, even within method B, there are differences in manufactured dendritic cell cytokine production.
For instance, it is clear from the numbers that not everybody in method B could have received secretion levels of tnf-alpha in excess of 130 ng per 1,000,000 DCs per 24 hours.
According to the charts at least, it would have been better if they all exceeded this level.
Likewise, I assume, IL-8 and IL-12p40 were probably only at really ideal levels in less than all method B. Also, don't forget, if possible they have to reduce or eliminate IL-10 producing DCs. IMHO. (As always, I do not believe they will share all the correlations they find for proprietary reasons)
There is a range of cytokine production within method B, and it might be up to the researchers and manufacturer, in coordination with regulators (and to the extent allowed by CBER), to make certain they hone in on that exact 'recipe' to produce the highly prized super DC. IMHO. However, at some point, perfectionism needs to take a backseat to pragmatism -- I suppose.
IMHO, It might really be a subset Dendritic Cell of method B, a "Super Method B" that I assume will be the outcome of this extended silence.
In that case, because Dr. Bosch had stated they will no longer use Method A, I expect a really high percentage of tumor stabilization at 8 weeks for patients entering the next trial, but more than that, I would expect most to benefit more from treatment due to all the improvements that we hope to see soon in more than one phase II trial. I also anticipate, IMHO, both method B and super method B tried out side by side, because Dr. Bosch's recent slides indicate they will attempt to prove their hypothesis that better potency results in better outcome.
At some point, it must be apparent that you can't get this right without very close coordination with a devoted manufacturer. I go back to the NASA concept. Sometimes one needs a cloistered group of patient researchers to get this right.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
