17 Feb 2015

VBL Therapeutics Announces Removal of FDA Partial Clinical Hold on VB-111

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TEL AVIV, Israel, Feb. 17, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: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 andEurope.

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.