VBL Therapeutics Announces Positive DSMC Review in Phase 3 GLOBE Trial Investigating VB-111 in rGBM
December 05 2016 - 7:00AM
VBL Therapeutics (NASDAQ:VBLT), today announced that the
independent Data Safety Monitoring Committee (DSMC) met to conduct
its first safety review of the Phase 3 GLOBE Study investigating
ofranergene obadenovec (VB-111) in recurrent glioblastoma
(rGBM). The DSMC is an independent multidisciplinary group
that conducts detailed review of un-blinded study data, discusses
potential safety concerns and provides recommendations regarding
trial continuation. The committee reviewed the GLOBE safety data
collected through a cutoff date in September 2016, and did not find
any adverse events that would be cause for concern. As a
result, the DSMC recommended that the study continue as
planned.
“We are pleased with the outcome of the DSMC, which strengthens
the safety profile of VB-111,” said Dror Harats, Chief Executive
Officer of VBL Therapeutics. “We continue to expect full
enrollment in the GLOBE study before year-end, with an event-driven
interim analysis expected sometime in mid-2017, and full trial
results expected in early 2018.”
The Phase 3 GLOBE study in rGBM is comparing VB-111 in
combination with Avastin® (bevacizumab) to Avastin alone and
is recruiting approximately 252 patients in the US, Canada and
Israel. The study is proceeding under a Special Protocol
Assessment (SPA) granted by the FDA, with full endorsement by the
Canadian Brain Tumor Consortium (CBTC). VB-111 has received
orphan drug designation in the United States and Europe and was
granted Fast Track designation by the FDA for prolongation of
survival in patients with glioblastoma that has recurred following
treatment with standard chemotherapy and radiation.
About Ofranergene Obadenovec
(VB-111)Ofranergene obadenovec is a unique biologic agent
that uses a dual mechanism to target solid tumors. Based on a
non-integrating, non-replicating, Adeno 5 vector, ofranergene
obadenovec utilizes VBL's proprietary Vascular Targeting System
(VTS™) to target the tumor vasculature for cancer therapy. Unlike
anti-VEGF or TKIs, ofranergene obadenovec does not aim to block a
specific pro-angiogenic pathway; instead, it uses an
angiogenesis-specific sensor (VBL's PPE-1-3x proprietary promoter)
to specifically induce cell death in angiogenic endothelial cells
in the tumor milieu. This mechanism retains activity regardless of
baseline tumor mutations or the identity of the pro-angiogenic
factors secreted by the tumor and shows efficacy even after failure
of prior treatment with other anti-angiogenics. Moreover,
ofranergene obadenovec induces specific anti-tumor immune response,
which is accompanied by recruitment of CD8 T-cells and apoptosis of
tumor cells.
Ofranergene obadenovec completed a Phase 2 study in rGBM, which
showed a statistically significant improvement in overall survival
in patients treated with ofranergene obadenovec through
progression, compared to either patients treated with ofranergene
obadenovec followed by bevacizumab alone, or to historical
bevacizumab data. In a Phase 2 trial for recurrent
platinum-resistant ovarian cancer, ofranergene obadenovec
demonstrated a statistically significant increase in overall
survival and 60% durable response rate (as measured by reduction in
CA-125), approximately 2x the historical response with bevacizumab
plus chemotherapy in ovarian cancer. In a Phase 2 study in
recurrent, iodine-resistant differentiated thyroid cancer,
ofranergene obadenovec met the primary endpoint demonstrating
disease stabilization with a positive safety profile, along with a
dose-response and evidence of an overall survival benefit.
Ofranergene obadenovec has received Fast Track Designation for
recurrent glioblastoma in the U.S. and orphan drug status for
glioblastoma in both the U.S. and EU.
About VBLVascular Biogenics Ltd., operating as
VBL Therapeutics, is a clinical stage biopharmaceutical company
focused on the discovery, development and commercialization of
first-in-class treatments for cancer. The Company’s lead oncology
product candidate, ofranergene obadenovec (VB-111), is a
first-in-class, targeted anti-cancer gene-therapy agent that is
positioned to treat a wide range of solid tumors. It is
conveniently administered as an IV infusion once every two months.
It has been observed to be well-tolerated in >200 cancer
patients and we have observed its efficacy signals in an “all
comers” Phase 1 trial as well as in three tumor-specific Phase 2
studies. Ofranergene obadenovec is currently being studied in a
Phase 3 pivotal trial for recurrent Glioblastoma, conducted under
an FDA Special Protocol Assessment (SPA).
Forward Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical fact are forward-looking statements, which
are often indicated by terms such as “anticipate,” “believe,”
“could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”,
“may,” “plan,” “potential,” “predict,” “project,” “should,” “will,”
“would” and similar expressions. These forward-looking statements
include, but are not limited to, statements regarding the clinical
development of ofranergene obadenovec (VB-111), including our
expectations regarding enrollment in the GLOBE study, and its
therapeutic potential and clinical results. These forward-looking
statements are not promises or guarantees and involve substantial
risks and uncertainties. Among the factors that could cause actual
results to differ materially from those described or projected
herein include uncertainties associated generally with research and
development, clinical trials and related regulatory reviews and
approvals, and the risk that historical clinical trial results may
not be predictive of future trial results. In particular, results
from our pivotal Phase 3 clinical trial of ofranergene obadenovec
(VB-111) in rGBM may not support approval of ofranergene obadenovec
for marketing in the United States, notwithstanding the positive
results seen in prior clinical experience. A further list and
description of these risks, uncertainties and other risks can be
found in the Company’s regulatory filings with the U.S. Securities
and Exchange Commission, including in our annual report on Form
20-F for the year ended December 31, 2015. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
VBL Therapeutics undertakes no obligation to update or revise the
information contained in this press release, whether as a result of
new information, future events or circumstances or otherwise.
Avastin® (bevacizumab) is a registered trademark of
Genentech Inc.
INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
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