Vascular Biogenics Ltd (VBLT)

[gr8db8]

Huge news release - 2nd DSMC review good to go. No AE concern!

Very interesting quote: “Based on enrollment trends and events that triggered the DSMC review, we currently expect the GLOBE Trial interim analysis to occur in mid-2017, and top-line results from the full dataset to be available in early 2018.”

Sounds like events are occurring on schedule. Hopefully, data supports findings in phase 2.


http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-newsArticle&ID=2263414

VBL Therapeutics Announces Positive DSMC Review in Phase 3 GLOBE Trial Investigating VB-111 in rGBM
TEL AVIV, Israel, April 20, 2017 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), today announced that the Independent Data Safety Monitoring Committee (DSMC) met to conduct its second safety review of the Phase 3 GLOBE Study investigating ofranergene obadenovec (VB-111) in recurrent glioblastoma (rGBM). The DSMC is an independent multidisciplinary group that conducts detailed reviews of un-blinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation. The committee reviewed the GLOBE safety data collected through a cutoff date in March 2017 and unanimously recommended that the study continue as planned.

“We are pleased with the outcome of the DSMC,” said Dror Harats, Chief Executive Officer of VBL Therapeutics. “Based on enrollment trends and events that triggered the DSMC review, we currently expect the GLOBE Trial interim analysis to occur in mid-2017, and top-line results from the full dataset to be available in early 2018.”

The Phase 3 GLOBE study in rGBM is comparing VB-111 in combination with Avastin® (bevacizumab) to Avastin alone and has recruited 256 patients in the US, Canada and Israel. The study is proceeding under a Special Protocol Assessment (SPA) granted by the FDA, with full endorsement by the Canadian Brain Tumor Consortium (CBTC). VB-111 has received orphan drug designation in the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation.