January 31, 2011
VBL Announces Initiation of Two Clinical Trials for VB-111, Targeted, Dual-Action, Anti-Angiogenic, Vascular Disruptive Agent for Cancer



Media Contact:


Dan Budwick, Pure Communications




VBL Announces Initiation of Two Clinical Trials for VB-111, Targeted, Dual-Action, Anti-Angiogenic, Vascular Disruptive Agent for Cancer


– Phase 2a trial in Thyroid Cancer, Phase 1/2 trial in Glioblastoma Multiforme –


TEL AVIV, Israel, January 31, 2011 – 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 (VTSTM) 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.”


About Thyroid Cancer

The U.S. National Cancer Institute estimates there were nearly 45,000 new cases of thyroid cancer diagnosed in the United States in 2010, mostly in women. Nearly two-thirds of cases occur in individuals between the ages of 20 and 55, according to the American Cancer Society.  While current treatments include surgery, radioactive iodine therapy, hormone therapy and chemotherapy, the majority of patients are currently treated effectively with surgery and/or radioactive iodine.  However, thyroid cancer can become resistant to radioactive iodine, limiting treatment options and leading to over 1600 annual deaths in the U.S. alone from the disease.  


About Glioblastoma Multiforme (GBM)

Glioblastoma multiforme (GBM) is the most common type of primary brain tumor. It is a very fast growing, highly malignant form of astrocytoma that can grow anywhere in the brain or spinal cord. According to the National Cancer Institute, about 19,000 people in the United States are diagnosed with primary brain cancers each year. Although GBM can occur at almost any age, it is most common in adults older than 50.


About VB-111

VB-111 is a dual-action, anti-angiogenic and Vascular Disruptive Agent (VDA) that utilizes VTS™, VBL’s proprietary platform technology for cancer therapy. VB-111 is an intravenously administered VDA that works in a manner akin to a “biological knife” to destroy tumor vasculature, thus cutting off the blood vessels feeding the tumor.


Preclinical pharmacological and toxicology studies of VB-111 showed tissue specificity for the tumor tissue, no significant damage to normal non-cancerous tissues or to the normal vasculatures in the body, and a more than 90 percent reduction in metastatic lung cancer model with one injection, as well as similar efficacy in other tumor models. A Phase 1 “all-comers” study of VB-111 in 33 patients with advanced metastatic cancer demonstrated antitumor activity and no effects on liver function or major changes in complete blood count.


About VBL Therapeutics

VBL Therapeutics is an innovative, clinical-stage biotechnology company committed to the development of novel treatments for immune-inflammatory diseases and cancer. VBL has pioneered the Lecinoxoid class of oral anti-inflammatory agents. VB-201 is the company’s lead candidate from this program, currently in Phase 2 clinical development in patients with psoriasis and patients with elevated hsCRP levels. In addition, VBL has a proprietary Vascular Targeting System (VTS™) technology platform that has yielded VB-111, a dual-action, anti-angiogenic and vascular disruptive agent (VDA) for cancer. The company is based in Tel Aviv, Israel. VBL has more than 70 granted patents and more than 110 patents pending. For more information on the company, please visit www.vblrx.com.