VBL Therapeutics Announces Data Safety Monitoring Committee Provides Green Light to Advance the OVAL Phase 3 Registration Ena...
February 22 2021 - 07:00AM
VBL Therapeutics (Nasdaq: VBLT) today announced the results of the
independent Data Safety Monitoring Committee (DSMC) pre-planned
review of the ongoing OVAL Phase 3 registration enabling study of
VB-111 in recurrent ovarian cancer. The committee found no safety
issues with the trial and recommended its continuation as planned.
"This review continues the trend of encouraging reviews that
have taken place since the clinical trial began," said
Prof. Dror Harats, Chief Executive Officer of VBL
Therapeutics. "The trial continues to enroll on track in the US,
Europe and Israel. We look forward to the next DSMC review during
the third quarter of 2021, followed by completion of enrollment at
the end of 2021 or in early 2022.”
In March 2020, the Company announced results of the first
interim analysis in the OVAL study, which reviewed unblinded data
and assessed CA-125 response, measured according to the GCIG
criteria, in the first 60 enrolled subjects evaluable for CA-125
analysis. The overall response rate across both arms was 53%. The
response rate in the treatment arm (VB-111 in addition to weekly
paclitaxel) was at least 10% higher than in the control, i.e., 58%
or higher. In patients who had post-dosing fever, which is a marker
for VB-111 treatment, the response rate was 69%. According to the
Company update on November 16, 2020, a high response rate of
>50% in the total evaluable patient population was maintained
with approximately 200 patients enrolled.
About the OVAL study
(NCT03398655)OVAL is an
international Phase 3 randomized pivotal registration enabling
clinical trial that compares a combination of VB-111 and paclitaxel
to placebo plus paclitaxel, in patients with platinum-resistant
ovarian cancer. The study is planned to enroll 400 patients. OVAL
is conducted in collaboration with the GOG Foundation, Inc.,
an independent international non-profit organization with the
purpose of promoting excellence in the quality and integrity of
clinical and basic scientific research in the field of gynecologic
malignancies.
About VB-111 (ofranergene obadenovec)VB-111 is
an investigational first-in-class, targeted anti-cancer
gene-therapy agent that is being developed to treat a wide range of
solid tumors. VB-111 is a unique biologic agent that uses a dual
mechanism to target solid tumors. Its mechanism combines blockade
of tumor vasculature with an anti-tumor immune response. VB-111 is
administered as an IV infusion once every 6-8 weeks. It has been
observed to be well-tolerated in >300 cancer patients and
demonstrated activity signals in an “all comers” Phase 1 trial as
well as in three tumor-specific Phase 2 studies. VB-111 has
received an Orphan Designation for the treatment of ovarian cancer
from the European Commission. VB-111 has also received orphan
drug designation in both the US and Europe, and fast track
designation in the US for prolongation of survival in patients with
rGBM. VB-111 successfully demonstrated proof-of-concept and
survival benefit in Phase 2 clinical trials in
radioiodine-refractory thyroid cancer and recurrent
platinum-resistant ovarian cancer.
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 areas of unmet need in cancer and
immune/inflammatory indications. For additional information visit:
www.vblrx.com.
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
may include, but are not limited to, statements regarding our
programs, including VB-111, including their clinical development,
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, the risk that historical clinical trial results may not
be predictive of future trial results, that our financial resources
do not last for as long as anticipated, and that we may not realize
the expected benefits of our intellectual property protection. In
particular, the DSMC recommendation that the OVAL trial proceed is
not assurance that the trial will meet its primary endpoint of
overall survival once completed, or that we will obtain positive
results to support further development of this candidate. A further
list and description of these risks, uncertainties and other risks
can be found in our 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, 2019, and subsequent filings with
the SEC. 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.
CONTACT:Burns McClellan for VBL
TherapeuticsLee Roth (investors) / Ryo Imai
(media)lroth@burnsmc.com / rimai@burnsmc.com+1-212-213-0006
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