Clinical Trials

Date: 2013-11-27

Type of information: Publication of results in a medical journal

phase: 2

Announcement:

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: glioblastoma multiforme (GBM)

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

• • On November 27, 2013, VBL Therapeutics has announced that the FD has granted Fast Track designation to its lead oncology drug VB-111, for prolongation of survival in patients with Recurrent Glioblastoma Multiforme (rGBM). VB-111 was already granted Orphan Drug status for GBM in the U.S. and in Europe. VBL has recently published Phase I/II results for VB-111 in the journal of Clinical Cancer Research. The Phase I/II trial for VB-111 demonstrated safety and tolerability in patients with advanced metastatic cancer at a single administration. Notably, tumor response and superior overall survival were found in the 1x1013 VPs cohort compared to sub-therapeutic doses. The data confirmed pre-clinical findings in animal models and validated VB-111's mechanism of action, resulting in a targeted expression of the Fas-Chimera transgene selectively in tumor vasculature.
• The Company has recently presented results from Phase II clinical study in patients with recurrent glioblastoma at the 2013 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago in June 2013. Data from the trial evaluating the effect of VB-111 on 28 patients with recurrent Glioblastoma Multiforme (rGBM) demonstrate that VB-111 was safe and well tolerated with repeat doses of up to 1x1013 VPs. Tumor responses and significant attenuation of tumor growth rate were seen. Overall survival was 12 months, which is at least 3 months longer compared to historical data in rGBM with the standard of care with chemotherapy and/or anti-angiogenic agents. In addition to GBM, VB-111 is also evaluated in multi-dose Phase 2 clinical trials for differentiated thyroid cancer and ovarian cancer.
• • 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