News Focus
News Focus
icon url

Rkmatters

01/31/17 5:12 PM

#99400 RE: AVII77 #99397

About 40 days after recurrent surgery would be the minimum. Impossible to know as there are missing variables for patients. We only have N=8 data that is cumulative:

Recurrent glioblastoma patients had previous radiation therapy and chemotherapy prior to presenting with tumor recurrence, so they underwent surgical resection of their tumors followed by DC immunotherapy after they had recovered from surgery and were tapered off peri-operative steroids. This ranged from 7–30 weeks after surgery.



“Tumor response was monitored by clinical and MRI assessments at baseline (within 1 month prior to therapy), and every 8 weeks thereafter as surrogate markers for clinical response and tumor status.” — UCLA paper



TTT period = recurrent surgery through to vaccine injection= 49 days to 210 days. I don't know which of N=8 patients waited 49 and which waited 210; but they all waited at least 49 days before first injection.

Baseline is within a month of First Injection. That is deducted from the TTT. But in DCVax-L Phase III it is 7 days. I can't imagine doing an MRI 30 days before first injection, and so I imaging it was meant to be 7-10 days before.

That would leave TTT from surgery to Baseline as 39 days minimum.

Baseline as -7 days from first injection
And first MRI 56 days after first injection.

63 days would be the first day that a patient could be removed for MRI progression (56 days after vaccine injections + 7 days BASELINE MRI).