Date: 2014-12-22
Type of
information: Results
phase: 2a
Announcement: results
Company: VBL Therapeutics (Israel)
Product: VB-111 (ofranergene obadenovec)
Action
mechanism:
- gene therapy. 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.
Disease: thyroid cancer
Therapeutic
area: Cancer - Oncology
Country: Canada, Israel, USA
Trial
details:
- The purpose of the pivotal, phase 3, randomized, multicenter GLOBE study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.(NCT02511405)
- 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.
Latest
news:
- • • On December 22, 2014, VBL Therapeutics announced positive results from its exploratory Phase 2a study of VB-111 in patients with recurrent, iodine-resistant differentiated thyroid cancer. VB-111 demonstrated disease stabilization and safety in the study, which was designed to assess the compound's safety and signal of efficacy. Thirty patients enrolled in the open label, dose-escalating study, most of whom had failed on several therapeutic lines, including tyrosine kinase inhibitors, prior to enrollment. Thirteen patients received a sub-therapeutic single dose of VB-111 at 3X10e12 VPs and seventeen received VB-111 at 10e13 VPs every two months until disease progression. Six patients (35%) in the therapeutic dose cohort (n=17) met the primary endpoint of 6-month progression-free survival using Response Evaluation Criteria in Solid Tumors (RECIST), compared to three patients (23%) in the low dose cohort (n=13). VB-111 was well-tolerated in both stages of this study, with no signs of clinically significant safety issues. VBL Therapeutics now plans to focus its efforts and resources on its pivotal Phase 3 study of VB-111 in recurrent glioblastoma, which the company plans to initiate in the first half of 2015.
- * On January 31, 2011, VBL Therapeutics has 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).
Is
general: Yes
