November 3, 2014
VBL Therapeutics to Present Interim Phase 2 Data from VB-111 in Recurrent Glioblastoma at 19th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO)
TEL AVIV, Israel, November 3, 2014 — VBL Therapeutics (NASDAQ: VBLT), a clinical-stage biotechnology company committed to the discovery, development and commercialization of first-in-class treatments for cancer and immune-inflammatory diseases, today announced that principal investigator, Andrew Brenner, MD, will present interim data from VBL’s ongoing Phase 2 clinical trial of its lead product candidate, VB-111, for the treatment of recurrent glioblastoma (rGBM), an aggressive form of brain cancer, in an oral presentation at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) in Miami, Florida. The interim data will include interim results in patients with rGBM treated by VB-111 and in combination with Avastin (bevacizumab), an anti-angiogenesis agent approved by the U.S. Food and Drug Administration (FDA), for use in rGBM.
VB-111, VBL’s lead oncology candidate, is an intravenously-administered, anti-angiogenic agent for the treatment of solid tumor indications, currently in clinical testing for the treatment of rGBM, thyroid cancer and ovarian cancer. This Phase 1/2 clinical trial is a multi-center, two stage, dose-escalation study designed to determine the safety, tolerability and efficacy of VB-111 in patients with rGBM. In the study’s second phase, patients received therapeutic doze of VB-111 and upon progression either bevacizumab alone or bevacizumab in combination with VB-111. VBL expects to initiate a pivotal Phase 3 trial of VB-111 in patients with rGBM in the first half of 2015 under a special protocol assessment agreement granted by the FDA.
Oral Presentation Details:
Title: Phase 1/2 Dose-Escalation Study of VB-111, an Anti-angiogenic Gene Therapy, as Monotherapy and in Combination with Bevacizumab, in Patients with Recurrent Glioblastoma
Time: Friday, November 14, 2014, 4:30 p.m. EST
Session: [3A : Clinical Trials]
Authors: A. Brenner (Institute for Drug Development, Cancer Therapy and Research Center, University of Texas Health Science Center), YC Cohen (VBL Therapeutics), J. Vredenburgh (Saint Francis Hospital and Medical Center), K Peters (The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center), L. Nayak (Center for Neuro-Oncology, Dana Farber Cancer Institute), DT Blumenthal (Division of Neuro-Oncology, Tel Aviv Sourasky Medical Center), F. Bokstein (Division of Neuro-Oncology, Tel Aviv Sourasky Medical Center), E. Breitbart (VBL Therapeutics),L. Bangio (VBL Therapeutics), N. Sher (VBL Therapeutics), D. Harats (VBL Therapeutics), PY Wen (Center for Neuro-Oncology, Dana Farber Cancer Institute).
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 and immune-inflammatory diseases. VBL Therapeutics’ clinical pipeline is based on two distinct, proprietary platform technologies—an oncology program and an anti-inflammatory program—that leverage the body’s natural physiologic and genetic regulatory elements. 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 the first half of 2015, under a special protocol assessment agreement granted by the FDA. VBL Therapeutics’ lead product candidate from its anti-inflammatory program, VB-201, is an oral small molecule currently being evaluated in Phase 2 clinical trials for psoriasis and for ulcerative colitis, with top-line results expected in the first quarter of 2015.
FORWARD LOOKING STATEMENTS
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. 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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