VBL Therapeutics Announces Positive Outcome in the Third and Final DSMC Review of Phase 3 GLOBE Trial Investigating VB-111 in...
October 02 2017 - 7:00AM
Top-line data expected in Q1 2018
VBL Therapeutics (NASDAQ:VBLT), today announced that the
independent Data Safety Monitoring Committee (DSMC) met on
September 28, 2017 to conduct its third and final safety review of
the Phase 3 GLOBE Study investigating ofranergene obadenovec
(VB-111) in recurrent glioblastoma (GBM). 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, including mortality data,
collected through a cutoff date in August 2017 and stated that they
did not identify any safety concerns. The DSMC confirmed that no
additional follow up will be necessary. Accordingly, the DSMC
unanimously recommended that the study continue as planned, to
completion.
“The positive DSMC recommendation supports the safety of VB-111
and represents an important milestone reached successfully in the
GLOBE study,” said Dror Harats, M.D., chief executive officer of
VBL Therapeutics. “No additional interim analyses are planned, and
we currently expect top-line results from the study to be available
in Q1 2018.”
Corinne Epperly, M.D., MPH, U.S. chief operating officer, added,
“This trial has the potential to be the first ever study with a
systemic drug candidate to help people with recurrent GBM live
significantly longer compared to a standard-of-care regimen. We
will work with the health authorities to bring this novel therapy
option to the patients who need it as quickly as possible.”
About the GLOBE studyThe Phase 3 GLOBE 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 promising and meaningful long-term survival in patients with
glioblastoma that has recurred following treatment with standard
chemotherapy and radiation. The study in recurrent GBM is comparing
VB-111 in combination with Avastin® (bevacizumab) to Avastin
alone and has recruited 256 patients in the US, Canada and Israel.
About Glioblastoma (GBM)GBM is the most common
and most aggressive form of primary brain tumors. In 2017, it is
estimated there will be approximately 12,000-13,000 new cases
diagnosed in the United States. Median overall survival (OS) from
diagnosis averages 12 to 15 months with patients treated usually
with surgery, chemotherapy and radiation. Progression occurs within
approximately 6 months in virtually all patients, and upon
progression median OS is about 6-8 months. Although significant
research and clinical efforts have focused on improving treatments
for recurrent GBM, no systemic therapy has shown an OS benefit,
resulting in a significant unmet medical need.
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 recurrent
GBM, 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 providing 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 >300 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 recurrent GBM
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 RiceLifeSci Advisors,
LLC(646) 597-6979
MEDIA CONTACT:Matt Middleman, M.D.LifeSci
Public Relationsmatt@lifescipublicrelations.com(646) 627-8384
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