TEL AVIV, Israel, Nov. 19, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced the presentation of new data on its lead oncology product VB-111, a first-in-class, targeted, anti-angiogenic gene-therapy agent with applicability for multiple solid tumor indications, at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), being held in San Antonio, Texas, showing significant improvement of 12 month overall survival (OS) with VB-111 in recurrent Glioblastoma multiforme (rGBM) compared to pooled data from four different Avastin® studies.
VB-111 is being featured in a poster presentation at SNO as well as in a satellite symposium sponsored by the company, both taking place Friday, November 20. New data are being presented that compare the 12 month overall survival achieved with VB-111 in rGBM to the results from four different trials of bevacizumab (Avastin®)1 in this disease setting (n=233). In the recently completed Phase 2 study, 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).
“This new analysis comparing our VB-111 results with multiple historical studies in rGBM demonstrates a clear 2-fold efficacy benefit,” stated Yael Cohen, M.D., Vice President, Clinical Development of VBL Therapeutics. “While there are limitations with comparing results across different clinical trials, this comparison gives us additional confidence in the treatment benefit of VB-111 in this patient population.”
“We are now actively recruiting patients in the Phase 3 GLOBE study of VB-111 in combination with bevacizumab and our goal is to have interim data in the first quarter of 2017,” continued Dr. Cohen. “We believe that VB-111 has the potential to change the treatment paradigm for rGBM patients, who are at great need for an effective therapy.”
VBL’s pivotal Phase 3 GLOBE study in rGBM which started in August 2015, is comparing VB-111 in combination with bevacizumab to bevacizumab alone and is recruiting about 252 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.
About the Society for Neuro-Oncology
The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education. Now in its nineteenth year, the Society continues to grow and mature as the premier North American organization for clinicians, basic scientists, nurses and other health care professionals whose focus is central nervous system tumors in children and adults.
About VB-111
VB-111 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 recurrent glioblastoma (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.
(1) Taal W et al. Lancet Oncol 2014;15: 943–53; Friedman HS et al. JCO 2009; 4733-40:(28)27; Chamberlain et al. J Neurooncol 2010; 96:259–269; Kreisl et al. JCO 2009; 27:740-745.
Avastin® is a registered trademark of Genentech Inc.
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