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VBL Therapeutics Announces Publication of NASH Data for Lecinoxoids Molecules VB-201 and VB-703

TEL AVIV, Israel, April 19, 2016 (GLOBE NEWSWIRE) -- VBL Therapeutics (NASDAQ:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today reported the publication of results for drug candidates VB-201 and VB-703 for the treatment of non-alcoholic steatohepatitis (NASH) and liver fibrosis in Digestive Diseases and Sciences magazine.

Previous studies have demonstrated that Toll-like receptors 2 and 4 (TLR-2 and TLR-4) play a role in nonalcoholic fatty liver disease. VBL has developed the Lecinoxoids, small molecules that antagonize TLR-2- and TLR-4-mediated activation and inhibit monocyte migration. Now VBL's novel findings demonstrate that Lecinoxoids can restrict liver inflammation and ameliorate liver fibrosis in a mouse model.

"Fibrosis is a major pathological feature of many chronic autoimmune diseases and TLRs have been implicated as being a part of the underlying pathogenesis, including in the liver setting", said Eyal Breitbart, PhD, Vice President of Research and Operations at VBL Therapeutics. “We believe that the Lecinoxoids offer a complementary therapeutic approach for treatment of these severe pathologies.”

To read the open-access article Treatment with Oxidized Phospholipids Directly Inhibits Nonalcoholic Steatohepatitis and Liver Fibrosis Without Affecting Steatosis click here.

About the Lecinoxoid Platform:
VBL Therapeutics has developed the Lecinoxoids, a novel class of orally-available anti-inflammatory small molecules. Lecinoxoids mimic the structure of native phospholipid molecules that regulate the inflammatory process in vivo; however, Lecinoxoids are synthesized chemically in a manner that increases their stability and ability to target specific receptors.

Lecinoxoids act through two specific mechanisms: (1) The inhibition of the Toll-like receptor (TLR) signaling by the TLR2 and CD14/TLR4 complexes – inflammatory pathways implicated in various inflammatory diseases; and (2) the inhibition of the migration of monocytes toward chemo-attractants present in areas of inflammation. This is a novel mechanism of action. By modulating innate immunity, the controller of the immune system, Lecinoxoids can potentially target a spectrum of immune-inflammatory diseases including cardiovascular diseases, NASH/Liver fibrosis, renal fibrosis and others.

The lead drug from the Lecinoxoids platform, VB-201, is an oral small molecule that has been administered to more than 600 patients, across eight trials and was observed to be safe. In an exploratory Phase 2 trial, VB-201 has demonstrated significant reduction of vascular inflammation, meeting the primary endpoint of the study. VB-201 is Phase-2-ready and can be employed directly in clinical trials.

Beyond VB-201, VBL has developed 2nd and 3rd generation structurally-related chemical compounds, which we believe offer greater pharmacological efficacy, higher mechanistic selectivity and longer patent term relative to VB-201. Some molecules, such as VB-703, have demonstrated promising preclinical results in NASH and renal fibrosis models.

About VBL:
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage 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 first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. VB-111 is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >170 cancer patients and we have observed its efficacy signals in an ”all comers“ Phase 1 trial as well as in three tumor-specific Phase 2 studies. The mechanism of VB-111 combines blockade of tumor vasculature with an anti-tumor immune response. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor. VB-111 is currently being studied in a Phase 3 pivotal trial for Recurrent Glioblastoma (rGBM). The trial is being conducted under an FDA Special Protocol Assessment (SPA), and VB-111 has obtained fast track and Orphan designations.

Forward Looking Statements:
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding the clinical development of VB-111 and its therapeutic potential and clinical results, including statements related to the Phase 3 pivotal trial for rGBM, and statements regarding our Lecinoxoids platform and its therapeutic potential and clinical results. 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.

INVESTOR CONTACT: Michael Rice LifeSci Advisors, LLC (646) 597-6979

Source: VBL Therapeutics