Phase 2 Study of VB-201 Shows Reduction in Liver Enzymes
Data Presented Today at H.C. Wainwright Annual NASH Investor Conference
TEL AVIV, Israel, April 03, 2017 (GLOBE NEWSWIRE) -- VBL Therapeutics (Nasdaq: VBLT ), announced today that in a post-hoc, hypothesis-driven analysis of data from completed Phase 2 studies, VB-201 appears to reduce certain liver enzymes. The data will be presented today at the H.C. Wainwright 1st Annual NASH Investor Conference, at the St. Regis Hotel in New York City.
| Presentation Details @ H.C. Wainwright NASH Investor Conference | ||
| Date: | Monday, April 3 | |
| Time: | 8:20am Eastern Time | |
| Presentation Room: | Versailles Room | |
| Webcast: | http://wsw.com/webcast/hcw/vbl | |
The analysis was conducted following the effect seen with VB-201 in pre-clinical models for non-alcoholic steatohepatitis (NASH) and renal fibrosis, in which VB-201 and VB-703, a next-generation Lecinoxoid drug candidate, reduced inflammation and fibrosis without affecting the lipid profile or steatosis.
VBL has studied VB-201 in five Phase 1 studies and three Phase 2 studies, some of which included patient populations known to have high rates of metabolic syndrome (e.g. psoriasis). In a retrospective analysis of liver enzyme tests performed for subjects dosed with VB-201, the Company identified a statistically significant time- and dose- dependent reduction of alkaline phosphatase (ALP) blood levels in patients treated orally with VB-201, which was reversed during a 4-week follow-up period after the patients completed the study. A similar but milder reduction was seen with levels of gamma-glutamyltransferase (GGT), an additional enzyme induced in liver damage. In the NASH setting, ALP and GGT may serve as biomarkers and lowering of ALP and GGT levels may indicate improvement in liver fibrosis. The decrease in ALP and GGT levels is in correlation with the Lecinoxoids anti-inflammatory/anti-fibrotic mechanism of action.
About VBL's 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. 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 relatively safe. In an exploratory Phase 2 trial, using a PET CT VB-201 has demonstrated significant reduction of atherosclerosis vascular inflammation, meeting the primary endpoint of the sub-study. VB-201 did not meet the primary endpoint in Phase 2 clinical trials for psoriasis and for ulcerative colitis, however it 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. We have observed promising preclinical results in NASH and renal fibrosis models in some molecules, such as VB-201 and VB-703.
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, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >200 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. Ofranergene obadenovec is currently being studied in a Phase 3 pivotal trial for recurrent Glioblastoma, conducted under an FDA Special Protocol Assessment (SPA).
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 ,including those related to VB-201, VB-703 and certain second and third generation Lecinoxoid compounds. 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
