TEL AVIV, Israel  February 17, 2015 I VBL Therapeutics (VBLT) a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer, today announced that the U.S. Food and Drug Administration (FDA) has determined that VBL may proceed with its pivotal Phase 3 trial in patients with recurrent glioblastoma (rGBM) and removed the clinical hold on the trial, allowing the trial to proceed under a previously agreed upon special protocol assessment (SPA).

“We have worked diligently with the FDA and anticipate initiating our Phase 3 pivotal trial of VB-111 in mid-2015,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We believe that VB-111 has significant potential as a gene therapy-based biologic for the treatment of solid tumors such as rGBM and look forward to harnessing our efforts in support of this important program.”

In July 2014, the Phase 3 study of VB-111 in rGBM was placed on clinical hold, pending the submission of additional properties regarding the VB-111 potency assay developed by VBL. Also in July 2014, pursuant to VBL’s request for an SPA, the FDA issued a concurrence with the design and planned analyses of this pivotal trial for a randomized, controlled, double-arm, open-label study of VB-111 with a primary endpoint of increased overall survival. Interim data is expected in the second half of 2016.

VBL recently reported positive data for VB-111 in rGBM and in thyroid cancer and is currently evaluating VB-111 in a clinical trial for ovarian cancer. VBL has also received fast track designation for VB-111 in the United States for prolongation of survival in patients with recurrent rGBM and orphan drug designation in both the United States and Europe.

In a simultaneous press release, VBL also reported today that it will discontinue development of a separate pipeline candidate VB-201 in ulcerative colitis and psoriasis following results of Phase 2 studies in these indications.

About VB-111:

VB-111 is a novel, intravenously-administered, anti-angiogenic agent that utilizes VBL’s proprietary Vascular Targeting System (VTS(TM)) to target endothelial cells in the tumor vasculature for cancer therapy. VB-111 contains a non-replicating adenovector, a proprietary modified murine pre-proendothelin promoter (PPE-1-3x) and a Fas-Chimera transgene to angiogenic tumor blood vessels, leading to their apoptosis. VB-111 is the first agent based on transcriptional targeting of tumor endothelium to be assessed in a clinical trial.

VB-111 completed a Phase 1/2 “all-comers” clinical trial, which demonstrated multiple cases of objective tumor response and disease control and excellent safety and tolerability. VB-111 has Fast Track Designation for recurrent glioblastoma in the US, and orphan drug status for glioblastoma in both the US and EU.

About VBL:

Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical-stage biopharmaceutical company committed to the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, VB-111, is a gene-based biologic that is initially being developed for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer. VB-111 has received orphan drug designation in both 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. VBL Therapeutics expects to begin the pivotal Phase 3 trial for VB-111 in rGBM in mid-2015, under a special protocol assessment agreement granted by the FDA.

SOURCE: VBL Therapeutics