-- Interim Data Suggest Improved Overall Survival in Patients Treated With VB-111 in Combination With Bevacizumab (Avastin®) --
TEL AVIV, Israel, Nov. 13, 2014 (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 and immune-inflammatory diseases, today announced positive preliminary results from its ongoing Phase 2 trial of VB-111 in patients with recurrent glioblastoma (rGBM). Improved overall survival was suggestive in patients with rGBM who received VB-111 as a standalone drug and who, upon further progression, were treated with VB-111 in combination with bevacizumab (Avastin®) compared to patients treated with bevacizumab alone upon further progression. These study results will be presented at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO) on November 14, 2014, at 4:30 pm ET, in Americana 3 at the Loews Hotel in Miami, Florida.
"These early clinical data with VB-111 in patients with recurrent GBM, are exciting and demonstrate the potential of the compound's novel mechanism of action and innovative gene therapy approach," said principal investigator, Andrew Brenner, MD, PhD, Clinical Investigator with the Cancer Therapy and Research Center at the University of Texas Health Science Center San Antonio. "The survival benefit trend seen in patients who continued on a combination regimen with VB-111 is promising, underscores the need for novel approaches to this debilitating disease, and highlights the potential for this drug to make a difference for our patients."
"We are pleased by these interim results and are excited to see increased survival in patients on VB-111," said Dror Harats, MD, Chief Executive Officer of VBL Therapeutics. "These preliminary results are particularly encouraging because, in this trial both longer exposure to VB-111 and combining VB-111 and bevacizumab led to an increase in median overall survival compared to treatment with bevacizumab alone, without safety or tolerability concerns. We look forward to advancing VB-111 into a pivotal Phase 3 clinical trial in 2015."
The interim Phase 2 data for VB-111 were presented for 46 patients with rGBM treated with VB-111; upon further progression, 23 of them were treated with VB-111 in combination with bevacizumab, and 23 received bevacizumab alone. VB-111 in combination with bevacizumab demonstrated a numerically improved median overall survival of 504 days, compared to 235 days in patients on VB-111 followed by bevacizumab alone. Tumor response data, available for 15 of the patients who received VB--111 in combination with bevacizumab, showed stable disease or better in 12 patients (80%), reduction of at least 25% in RANO score in nine patients (60%) and partial response, defined by at least 50% reduction in tumor mass, in 3 patients (20%). The Company believes that this decrease in tumor mass and the subsequent increase in overall survival resulted from either increased exposure to VB-111 and/or a synergistic effect of VB-111 combined with bevacizumab, and support the design of VBL's pivotal Phase 3 study, set to begin in the first half of 2015 under a special protocol assessment agreement granted by the FDA.
In this study, VB-111 was safe and well-tolerated both as a monotherapy and in combination with bevacizumab. Most adverse events observed in the study were low-grade flu-like symptoms, including fever and chills, which occurred on the day of treatment at approximately six hours after infusion, and were transient and controlled with anti-fever medications.
This Phase 1/2 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 first phase of the study, patients were treated with VB-111 alone. Upon disease progression, defined as a worsening of the patient's cancer with an increase of at least 25% in the overall mass of measurable tumors, the appearance of new tumors, the worsening of non-measurable tumors since the beginning of treatment, a need for increased dose of corticosteroids, or clinical deterioration, patients received either bevacizumab alone or bevacizumab in combination with VB-111.
About VB-111:
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 adenovector, 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 orphan drug status for glioblastoma in both the US and EU. VB-111 has also been advanced into tumor specific, repeat-dose trials in thyroid and ovarian cancer.
About VBL:
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.