VBL Therapeutics Receives FDA Fast Track For Brain Cancer Drug

The Company’s VB-111 is a gene therapy for prolonging the survival in patients with recurrent Glioblastoma Multiforme (rGBM), an aggressive form of brain cancer.


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VBL Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM).

GBM is an aggressive form of brain cancer which carries a very poor prognosis with current therapy. VB-111 was already granted Orphan Drug status for GBM in the U.S. and in Europe.

VB-111, given as a simple IV infusion, is a novel gene-therapy drug that targets endothelial cells in the tumor vasculature, acting as a “biological knife”.
Based on a non-replicating adenoviral vector, VB-111 harbors a proprietary promoter which regulates transcription of a Fas-Chimera transgene, leading to targeted cell-death of endothelial cells in tumor-feeding blood vessels, 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.

VBL, a clinical-stage biotechnology company committed to the development of novel treatments for cancer and immune-inflammatory diseases, has recently published Phase I/II results for VB-111 in the journal of Clinical Cancer Research.

The Phase I/II trial for VB-111 demonstrated safety and tolerability in patients with advanced metastatic cancer at a single administration. Notably, tumor response and superior overall survival were found in the 1×1013 VPs cohort compared to sub-therapeutic doses.
The Company has recently presented results from Phase II clinical study in patients with recurrent glioblastoma at the 2013 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago in June 2013.

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. Tumor responses and significant attenuation of tumor growth rate were seen. Overall survival was 12 months, which is at least 3 months longer compared to historical data in rGBM with the standard of care with chemotherapy and/or anti-angiogenic agents.
VBL’s platform and clinical data also attracted significant attention at a satellite symposium on VB‐111 held at the 2013 Scientific Meetings of the Society for Neuro-Oncology (SNO) and the World Federation of Neuro-Oncology in San Francisco last week.

VBL Founded in 2000 and is based in Tel Aviv, Israel. The company has more than 120 granted patents and more than 150 applications pending.

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