VBL Therapeutics Announces Positive DSMC Review in Phase 3 GLOBE Trial Investigating VB-111 in rGBM
April 20 2017 - 4:01PM
VBL Therapeutics (NASDAQ:VBLT), today announced that the
Independent Data Safety Monitoring Committee (DSMC) met to conduct
its second 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 reviews 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 March 2017 and unanimously
recommended that the study continue as planned.
“We are pleased with the outcome of the DSMC,” said Dror Harats,
Chief Executive Officer of VBL Therapeutics. “Based on
enrollment trends and events that triggered the DSMC review, we
currently expect the GLOBE Trial interim analysis to occur in
mid-2017, and top-line results from the full dataset to be
available in early 2018.”
The Phase 3 GLOBE study in rGBM is comparing VB-111 in
combination with Avastin® (bevacizumab) to Avastin alone and
has recruited 256 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 activity even after failure
of prior treatment with other anti-angiogenics. In addition,
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 twice 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 and provided
evidence of 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 the timing of results from 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, 2016. 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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