TEL AVIV, Israel, Dec. 1, 2015 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), today announced the grant of US Patent No. 9,200,056, entitled “A Fas-Chimera Adenovirus Vector” by the United State Patent Office (USPTO) which covers VB-111, VBL’s lead drug candidate. This composition patent provides intellectual property protection for VB-111 in the US until October 2033 before any patent term extension.
“This granted patent is exceptionally important to VBL since it secures IP rights for VB-111 in multiple oncology indications until at least 2033. It is a strong addition to our Vascular Targeting System (VTS™) portfolio,” said Erez Feige, Ph.D., Vice President of Business Operations of VBL Therapeutics.
“The issuance of this patent gives us at least 18 years of exclusivity on our lead drug candidate, VB-111, which is currently being investigated in our GLOBE Phase 3 pivotal trial for recurrent GBM, in addition to Phase 2 trials in platinum-resistant ovarian cancer and radioactive-iodine refractory differentiated thyroid cancer. With positive data from three cancer indications and such a long IP lifespan, our goal is to exploit the full potential of VB-111 in multiple oncology indications,” said Dror Harats, M.D., CEO of VBL Therapeutics.
Recently, VBL presented data from its Phase 2 trial of VB-111 in recurrent glioblastoma multiforme (rGBM), which demonstrated that the overall survival rate for patients treated with VB-111 in combination with bevacizumab (Avastin®) 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 data pooled from four Avastin® studies (p = 0.007).
VBL’s pivotal Phase 3 GLOBE study in rGBM 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 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, enforcement of our patent rights could require resources and involve us in litigation, the result of which is inherently uncertain. In addition, it is possible that our patent covering VB-111 may be disputed by third parties. 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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