TEL AVIV, Israel, July 14, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced that Chief Executive Officer, Dror Harats, M.D., will present data regarding the Company's Vascular Targeting System™ (VTS) and its lead product VB-111 in an oral presentation on Wednesday, July 22, 2015 at the Drug Discovery and Therapy World Congress 2015 in Boston, Massachusetts.
VBL recently reported interim Phase 2 data evaluating VB-111 in patients with rGBM, which showed a statistically significant overall survival benefit in patients treated with VB-111 followed by VB-111 in combination with bevacizumab (Avastin™) upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone (median overall survival of 16 vs. 8 months, respectively; p=0.05). VBL expects to initiate a pivotal Phase 3 study in rGBM under a Special Protocol Assessment with the U.S. Food and Drug Administration in mid-2015. At the American Society of Clinical Oncology (ASCO) Annual Meeting in June, the Company reported promising Phase 1/2 data in a second solid tumor indication evaluating VB-111 for the treatment of platinum-resistant Müllerian cancer, demonstrating evidence of clinical benefit even in patients who previously failed on bevacizumab.
VB-111 is the Company's lead product based on the innovative VTS platform gene therapy technology, which enables targeted and specific expression of a gene of choice in angiogenic blood vessels through unique "super enhancer" DNA regulatory sequences. VTS is comprised of three elements: a viral vector as a delivery tool, VBL's proprietary, semi-artificial PPE-1-3x promoter, and a transgene of choice. The technology can be employed for various purposes, including detecting, promoting or destroying newly-formed blood vessels in various pathological conditions.
As the first highly targeted anti-angiogenic agent for the specific inhibition of tumor vascular growth to use VBL's VTS for cancer therapy, VB-111 has the potential to treat a range of solid tumor indications by selectively targeting the blood vessels required for tumor growth. Since VB-111 causes apoptosis of cells that turn on its proprietary endothelial promoter due to angiogenesis, whether stimulated by VEGF or other signals, we believe it has the potential to be effective whatever the mechanism driving new tumor vascular growth. VB-111's activity is not limited to a certain tumor type or a subset of cells carrying a specific mutation and, because it works through the vasculature, VB-111 is also able to target brain tumors without crossing the blood-brain barrier. Furthermore, VB-111 may induce an immune response that potentiates its anti-angiogenic effect.
Details of the presentation are as follows:
|Title:||Vascular Targeting System – a Proprietary Gene Therapy Platform Technology|
|Time:||Wednesday, July 22, 2015, 12:20 – 12:40 p.m. ET|
|Track:||Cancer Targeted Drug Discovery|
VB-111 is a novel, intravenously-administered, 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 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 organ drug status for glioblastoma in both the US and EU. Beyond GBM, VBL is also conducting early phase II studies in thyroid and ovarian cancer.
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, 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 clinical trial of VB-111 in rGBM in mid-2015, under a special protocol assessment agreement granted by the FDA.
This press release contains forward-looking statements. 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, notwithstanding the positive results seen in our current clinical trial. 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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Source: VBL Therapeutics