VBL Therapeutics Announces Completion of Enrollment in the Pivotal GLOBE Study
January 06 2017 - 7:00AM
VBL Therapeutics (NASDAQ:VBLT), announced today that it has
completed enrollment in the GLOBE Phase 3 study evaluating the
efficacy of its lead candidate ofranergene obadenovec (VB-111) in
patients with recurrent glioblastoma (rGBM). Enrollment in the
study, 256 patients in total, has been completed five months ahead
of schedule.
“We are very encouraged by the high level of
interest shown by both patients and physicians in GLOBE, resulting
in completion of enrollment five months ahead of plan,” said
Professor Dror Harats, M.D., Chief Executive Officer of VBL.
"VB-111 has generated positive data in several tumor types,
including a statistically significant overall survival benefit in
rGBM. We are hopeful that the GLOBE trial will confirm these
positive findings and generate the data required to support
registration.”
VBL has also received FDA approval for adjustments
in the GLOBE protocol. These major modifications relate to
the triggers for the interim and final analyses. The SPA covering
GLOBE remains in place. Originally, the interim analysis in
GLOBE was to be conducted after 91 deaths. The modified protocol
specifies that it will be conducted after 105 deaths, and after 50%
of the patients have more than 12 months potential follow up,
whichever occurs later. The final analysis will be conducted
at 189 deaths (75% of events), versus the original planned for 151
deaths (60% of events).
These adjustments to the GLOBE protocol are
intended to provide better powering and increase the probability
for a clearer efficacy signal. Given the fast recruitment
pace and completion of recruitment ahead of schedule, the company
continues to expect that the interim analysis will occur in
mid-2017 and that the top-line results from the full dataset will
be available in early 2018.
About VBL Vascular 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).
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 and provided
evidence of disease stabilization and a positive safety profile
along with a dose-response. Data also showed evidence of an overall
survival benefit for patients treated with the therapeutic
dose. 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 the GLOBE Study VBL's
pivotal 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 has been 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. More information about
the GLOBE trial can be found here:
https://www.clinicaltrials.gov/ct2/show/NCT02511405
Forward Looking Statements This
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) and its therapeutic potential and clinical
results, the timing of announcement of results from the GLOBE Phase
3 study, regulatory approval of VB-111 in the targeted indications
and the intended benefits of the adjustments to the GLOBE protocol.
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.
INVESTOR CONTACT:
Michael Rice
LifeSci Advisors, LLC
(646) 597-6979
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