TEL AVIV, Israel, Feb. 22, 2016 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), today announced enrollment of the first patient in Israel, as part of the GLOBE Phase 3 pivotal trial for lead candidate VB-111. The trial, which was commenced in the US in August 2015, is comparing VB-111 in combination with bevacizumab (Avastin®) to bevacizumab alone in recurrent glioblastoma (rGBM). GLOBE has been designed to recruit approximately 252 patients in the US, Canada and Israel, and is expected to include 6 leading Israeli medical centers.
In November 2015, at the Society for Neuro-Oncology (SNO) conference, VBL reported data from its recently-completed Phase 2 multi-center study of VB-111 in rGBM, which showed that VB-111 almost doubled the historical median overall survival for rGBM. Patients treated with continuous exposure of VB-111 had median overall survival (OS) of 15 months, compared to 8 months in patients with limited VB-111 exposure (p=0.048). The overall survival rate for patients treated with VB-111 in combination with bevacizumab upon disease progression (continuous exposure cohort) was 57% at 12 months. This compares with an overall 12 month survival of 28% (range 16% to 38%) in the pooled data from the 4 Avastin™ studies (p = 0.007).
“We are excited to begin enrollment to the GLOBE study for rGBM in Israel,” stated Dr. Yael Cohen, VP of Clinical development at VBL. “We believe that VB-111 is a unique biologic drug candidate that has the potential to change the treatment paradigm for patients with this devastating disease.”
"The huge unmet need for an effective therapy in glioblastoma warrants clinical evaluation of novel therapies," said Tzahala Tzuk-Shina, MD, Head of the Neuro-oncology Unit, Rambam Health Care Campus, Haifa, Israel. "We are proud to be the first Israeli clinical site in this important rGBM trial and will continue our efforts to provide patients with access to innovative clinical options such as VB-111," added Dr. Tzuk-Shina.
VBL's pivotal Phase 3 GLOBE 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 has been 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.
About VB-111
VB-111 (ofranergene obadenovec) is a novel, intravenously-administered, targeted anti-angiogenic agent that utilizes VBL's proprietary Vascular Targeting System (VTS™) to target endothelial cells in the tumor vasculature for cancer therapy. VB-111 contains a non-replicating adenovirus, a proprietary modified murine pre-proendothelin promoter (PPE-1-3x) and a Fas-Chimera transgene which is specifically activated in 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 2 study in rGBM, which showed a statistically significant improvement in overall survival in patients treated with VB-111 followed by VB-111 in combination with bevacizumab upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone. VB-111 is also being studied in a Phase 2 trial in recurrent platinum-resistant ovarian cancer, which provided promising evidence of clinical benefit in an interim analysis, and in a Phase 2 study in recurrent, iodine-resistant differentiated thyroid cancer, which provided evidence of disease stabilization and a positive safety profile. VB-111 has Fast Track Designation for recurrent glioblastoma in the U.S. and orphan drug status for glioblastoma in both the U.S. and EU.
About VBL
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a late-stage clinical biopharmaceutical company focused on 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 (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' pivotal Phase 3 GLOBE trial of VB-111 in rGBM is ongoing under a special protocol assessment granted by the FDA.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our proposed pivotal Phase 3 clinical trial of VB-111 in rGBM may not support approval of VB-111 for marketing in the United States. A further list and description of these risks, uncertainties and other risks can be found in the company's regulatory filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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