Replies to post #99195 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Rkmatters,

Correct, both Dr. Prins and Dr
Liau sources are the same 14.9 mo MOS. My main point is that 11 months is still better than historical norms for RGBM and 2 months difference is all that is needed for approval in most cases especially in GBM. As you point out, the improved dosing schedule will make a big difference. There are strong biologically related reasons for this. This is why I suggested that 2 week intervals would be used for future Direct trials and sure enough, the early doses are set at 1 week to sufficiently prime for the first 2 weeks then 2 week intervals begin. Once immune memory has time to be established to a certain degree and optimum systemic response observed the spacing can go to 3 weeks as flipper44 suggested would happen. If Direct needs to be optimized in some cancers by pairing it with a checkpoint inhibitor then they want to choose the best one or group of undefined ones to be included in their checkpoint combination patent. That is where mega billions are at stake because Direct is much cheaper to produce than L and will be much more effective in most if not eventually all cases when modified. Best wishes.

[AVII77]

Did you notice that he has been using the first Phase I trial as his example of what he calls poor survival? We are talking pre-STUPP protocol. -RKMatters

That is a gross mischaracterization.

Here, let me help you.

For this subgroup of patients, the median overall survival was 11.7 months, which is not significantly different from those of historical and concurrent glioblastoma multiforme patients treated at our institution. - Dr. Liau's 2005 pre-Stupp paper

You are taking Dr. Liau's words and twisting them to suit your incorrect view.

But I am glad you brought up her first Phase 1 paper. It gave me the opportunity to see how they handled "time zero" for their measurement of OS in rGBM.

Did they do it the way you repeatedly assert (from injection)?

Let's see......




No, it's not as you assert. They did it the same exact way as I said, from the surgery.

By the way, do you see Patient 5 above? In the meta-analysis paper they report 1 patient with an "objective response" to DCVax.

She's still alive today.

But there are two things to note about this patient.
1. She would not have made it to randomization in the Phase 3 trial.
2. Her "objective Response" was very likely pseudoprogression. Or, as Dr. Liau said in her paper:

One patient (patient 5) had near complete regression of residual tumor, which was seen on MRI 2 months after completion of peptide-pulsed dendritic cell vaccination and before any additional adjuvant treatment. Both the size of the areas of T2W hyperintensity and the contrast-enhancing tumor decreased in this patient (Fig. 2). Although this radiographic change is more likely related to a delayed response to radiation therapy, it is interesting to speculate that dendritic cell–based immunotherapy might have contributed to this clinical response,

Earlier I challenged MD1225 to figure out what all 4 still-living patients from the two earlier DCVax trials had in common. This is one of those 4 patients (the other 3 are from the second Phase I/II trial). For all 4 of these patients, their MRI got "worse" before it got "better". Think back to the Hoos videos recently discussed. What does that suggest for PFS?