'Recurrent GBM is a complex disease which grows by walling itself off from the immune system, making it so devastating. It appears that placing IL-12 within the tumor and then controlling the production of this cytokine, drives T cells into the tumor, enabling the immune system to adapt, which leads to anti-tumor activity,' said
The Company announced in
Interim Update Reported
Decrease in tumor from baseline (time of Ad+V administration) resulting in a patient's lesion being too small to measure, assessed as a partial response (per iRANO), with follow up ongoing
Subjects were comparable to the Main study except a higher percentage in the Expansion substudy had multifocal disease vs. unifocal disease and fewer recurrences
Based on study design there was, as expected, a higher percentage of subjects in the Expansion substudy as compared with Main study (75% vs 40%) who received low-dose concurrent steroids
Local, regulated IL-12 production using Ad+V in subjects with rGBM rapidly and safely activates the immune system
Peak serum IL-12 at Day 3 with downstream production of endogenous IFN-peaking at Day 7 in Expansion substudy (and Main study)
MRI findings of pseudoprogression, consistent with immune-mediated anti-tumor effects
20mg V subjects (Main + Expansion, n=20) with unifocal disease at entry, receiving low-dose steroids (defined as
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