Date: 2012-12-18
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
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: ovarian cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This is a prospective, open label, dose escalating, Phase I/II study, measuring mainly the safety and tolerability of the combination of intravenous administration of VB-111 and paclitaxel in patients with platinum resistant ovarian cancer. (NCT01711970)
Latest
news: * On December 18, 2012, a Phase I-2 trial sponsored by VBL Therapeutics was published on the NIH website ClinicalTrials.gov for VB-111 (ofranergene obadenovec) and is currently ongoing.
