3 Jun 2013

Phase I/II Data of VB-111 Demonstrate Anti-Tumor Effects with Increase in Overall Survival with This Anti-Angiogenic Gene Therapy, in Patients with Recurrent Glioblastoma Multiforme

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TEL AVIV, Israel--(BUSINESS WIRE)-- VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced clinical data demonstrating the utility of VB-111’s in targeted cancer treatment. The company presented results from Phase I/II clinical study in patients with recurrent glioblastoma at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Data from the trial evaluating the effect of VB-111 on 28 patients with recurrent Glioblastoma Multiforme (rGBM) demonstrate that VB-111 was safe and well tolerated with repeat doses of up to 1x1013 VPs. Tumor responses and significant attenuation of tumor growth rate were seen. Overall survival was about 3 months longer compared to historical data in rGBM with the standard of care with anti-angiogenic agents.

The poster (#TPS2102) entitled “Phase I/II dose-escalation study of VB-111, an antiangiogenic gene therapy, in patients with recurrent glioblastoma multiforme,” by Brenner et al., was presented on June 1st, 2013, and its abstract is now available on the ASCO annual meeting website.

VB-111 is a novel anti-angiogenic gene-therapy tool that targets endothelial cells in the tumor vasculature. Based on a non-replicating adenoviral vector, it harbors a uniquely modified pre-proendothelin promoter (PPE-1-3x) which regulates transcription of a Fas-Chimera transgene. The proprietary promoter specifically targets expression of the Fas-Chimera transgene to angiogenic tumor blood vessels, leading to their apoptosis, with no harm to normal vasculature and non-cancerous tissues in the body. VB-111 is the first agent based on transcriptional targeting of tumor endothelium to be assessed in a clinical trial.

Twenty eight patients with rGBM aged 26 – 74 years, enrolled the trial between Dec.2010 – Aug.2012 in three US medical centers: the Dana-Farber Cancer Institute, Duke University Medical Center and the University Of Texas Health Science Center. Patients received up to 8 repeat doses of VB-111. The median overall survival was 360 days for patients receiving at least one dose of 1x1013 VPs (high dose).  Progression free survival was 87 vs 55 days for patients who received high dose vs. lower doses, respectively (p=0.01). Median follow-up was 232 days. Two patients had a partial response (PR) at 82 and 408 days post initial VB-111 dosing. Twenty one of the patients who eventually progressed after VB-111 treatment received bevacizumab off study; 7 of the 15 evaluable patients (47%) had a partial response (PR) compared to a 30% expected PR rate according to literature. VB-111 was safe and well tolerated.

 We were pleased to present our promising results at the ASCO conference”, said Professor Dror Harats, M.D., chief executive officer of VBL. “The efficacy and unique endothelial-specificity of our VTSTM platform is evidently translated to humans. Our data demonstrate VB-111’s potency as a targeted cancer treatment, which seems to prolong overall survival in rGBM patients. We are confident in the therapeutic potential of VB-111 and continue to advance its clinical trials in gliobastoma multiforme, differentiated thyroid cancer and ovarian cancer".

 Phase I data for VB-111 was recently published in the journal of Clinical Cancer Research. The manuscript reported a first in man clinical trial of VB-111, demonstrating its safety and tolerability in patients with advanced metastatic cancer at a single administration of up to 1x1013 Viral Particles (VPs). Notably, tumor response and superior overall survival were found in the 1x1013 VPs cohort compared to sub-therapeutic doses. The data confirm pre-clinical findings in animal models and validate VB-111's mechanism of action, resulting in a targeted expression of the Fas-Chimera transgene selectively in tumor vasculature. For access to the manuscript please see: http://www.ncbi.nlm.nih.gov/pubmed/23589178


About VB-111

VB-111 is an IV-administered anti angiogenic agent that utilizes VTS™, VBL’s proprietary platform technology for cancer therapy. VB-111 works like a “biological knife”, cutting off the blood vessels feeding the tumor.

Preclinical pharmacological and toxicology studies of VB-111 showed tissue specificity for the tumor tissue, with no significant damage to normal non-cancerous tissues or to the normal vasculatures in the body. Intravenous treatment with VB-111 resulted in more than 90 percent reduction of tumor burden in a mouse metastatic lung cancer model with one injection, as well as similar efficacy in other tumor models. VB-111 is currently being studied in multi-dose Phase 2 clinical trials for gliobastoma multiforme, differentiated thyroid cancer and ovarian cancer.