VBL Therapeutics Ltd. has obtained fast-track designation from the US Food and Drug Administration (FDA) for its brain cancer drug. VB-111 is a gene therapy for prolonging the survival in patients with recurrent Glioblastoma Multiforme (rGBM), an aggressive form of brain cancer which carries a very poor prognosis with current therapy
VB-111 already has orphan drug status in the US and Europe. The drug, 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", through targeted cell-death of endothelial cells in tumor-feeding blood vessels.
In mid-2013, VBL reported that VB-111 demonstrated safety and tolerability in a Phase I/II clinical trial of brain cancer patients. The company is also carrying out a Phase II clinical trial of the drug for differentiated thyroid cancer and ovarian cancer.
“The Fast Track designation is another significant milestone reached in our program for approval of VB-111 as a unique drug for rGBM. We are very pleased that the FDA recognized the potential for this novel therapy to treat this serious and devastating cancer" said VBL CEO Dr. Dror Harats. “Building on the promising data from our Phase II trial, we plan ahead for a pivotal trial with VB-111 for rGBM under the Fast Track program which should expedite the development of VB-111."
Tel Aviv-based VBL was founded in 2000. It has more than 120 patents and has filed for over 150 patent applications.
Published by Globes [online], Israel business news - www.globes-online.com - on November 28, 2013
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