VB-111, is a first-in class targeted anti-cancer biologic agent that is positioned to treat a wide range of solid tumors that we are initially developing for recurrent glioblastoma. We have obtained fast track designation for VB-111 in the United States. We have also received orphan drug designation in both the United States and Europe.
On September 2015 at the European Cancer Conference (ECC 2015), VBL Therapeutics reported full Phase 2 data from a multi-center clinical trial of VB-111 in rGBM, meeting the primary endpoint of statistically-significant increase in overall survival.
On June 2016, at the 2016 American Society of Clinical Oncology (ASCO) annual meeting, VBL reported new data comparing Phase 2 clinical outcomes with VB-111 with pooled data from 8 studies that investigated Avastin in recurrent glioblastoma (rGBM). In the Phase 2 VB-111 trial, the median overall survival of patients who received continuous exposure of VB-111 in combination with Avastin was 59 weeks. This is compared to 32 weeks in the pooled data from the 8 studies in the meta-analysis (p= 0.0295 Hazard Ratio 0.62, 95% CI: 0.40-0.96). Median survival ranged from 26.0 weeks to 45.7 weeks in the meta-analysis. Overall survival at 12 months for patients on continuous exposure of VB-111 was 57%, compared to 24% overall survival (range 16% – 38%) for the pooled data (p= 0.03).
See also the VB-111 Poster at ASCO 2016
VBL Therapeutics’ pivotal Phase 3 GLOBE trial of VB-111 in rGBM is ongoing under a special protocol assessment granted by the FDA. The trial is conducted in the US, Canada and Israel .
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