VBL commences two studies to evaluate efficacy, safety of VB-111 in advanced cancers

VBL Therapeutics, a clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer, today announced the initiation of two studies to further evaluate the efficacy and safety of VB-111 in advanced cancers. The first, a Phase 2a study, will evaluate the efficacy and safety of VB-111 among patients with advanced differentiated thyroid cancer (DTC). The second trial, a Phase 1/2 trial, will evaluate the efficacy, tolerability and safety of VB-111 among patients with relapsed glioblastoma multiforme (GBM).

VB-111 is a targeted, dual-action, anti-angiogenic and vascular disruptive agent (VDA) specifically developed as a candidate cancer therapeutic. Its targeted mechanism effectively works as a "biological knife," cutting off the blood vessels feeding the tumor without apparently causing damage to normal tissue vasculatures. VB-111 is a product of VBL's innovative, proprietary Vascular Targeting System (VTS^TM) platform technology, which enables control of gene expression in areas in which angiogenesis is taking place in order to selectively promote or destroy newly formed blood vessels.

"We are thrilled to announce the initiation of these two clinical trials for VB-111, as they represent an important step forward for this program," said Professor Dror Harats, M.D., chief executive officer of VBL. "We are committed to developing unique, targeted cancer treatments that address an unmet need and we are hopeful that these trials will demonstrate VB-111's clinical potential for two groups of patients whose current treatment options are limited."

First Phase 2a study

Based on positive preliminary data from a Phase 1 study of patients with advanced metastatic cancer, VBL has initiated a multi-site study that will enroll up to 82 total subjects with thyroid cancer. All study participants will have been previously treated with radioiodine and will be divided into two cohorts, the first including patients with no former anti-angiogenic treatment and the second including patients who have received at least one conventional anti-angiogenic therapy. This study will assess efficacy and will characterize the safety and tolerability of VB-111 in DTC.

"Thyroid cancer patients are in serious need of targeted treatments that effectively manage their disease," said Keith Bible, M.D., Ph.D., the lead investigator of the study from the Mayo Clinic. "While radioactive iodine can be an effective treatment for metastatic thyroid cancer, not all thyroid cancers concentrate iodine and some patients become resistant to it. Those patients are left with few treatment options. VB-111's unique mechanism of action shows exciting potential to treat this population of patients with thyroid cancer."

VB-111 in GBM

This Phase 1/2 prospective, open-label, single-dose, multi-center study will enroll patients with relapsed GBM. Researchers will evaluate its effect, as measured by six months of progression-free survival. The study will also examine the bio-distribution of VB-111 in the body. Finally, the study will assess and characterize VB-111's safety and tolerability.

"GBM is an extremely aggressive form of brain cancer and it is exceedingly hard to treat with currently available therapies, which include surgery, radiation and chemotherapy," said James Vredenburgh, M.D., the lead investigator of the study from Duke University Medical Center. "These therapies are palliative in nature, not curative, leaving patients with few treatment options. We are hopeful that the positive Phase 1/2 results we have seen with VB-111 will be validated by this study."