VBL Therapeutics Announces Top-Line Results from Pivotal Phase 3 GLOBE Study in Patients with Recurrent Glioblastoma
March 08 2018 - 6:00AM
Conference Call and Webcast @ 8:30am ET Today
VBL Therapeutics (Nasdaq:VBLT), today reported top-line results
from its pivotal Phase 3 GLOBE study in patients with recurrent
glioblastoma (rGBM) which was designed to evaluate VB-111 in
combination with bevacizumab (Avastin®), compared to the
bevacizumab control arm. The study did not meet its
pre-specified primary endpoint of overall survival (OS).
Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics,
said "We are disappointed that our encouraging Phase 2 data were
not replicated in the GLOBE Phase 3 study, and once we receive the
full and final data we will be analyzing them carefully to better
understand the outcome of the study. We are grateful to the trial
investigators, site personnel, patients and caregivers who
participated in GLOBE. We believe that VB-111 may still hold
promise for other indications we currently or may study in the
future.”
Conference Call |
Thursday, March 8 at 8:30am Eastern Time |
US Investors: |
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800-239-9838 |
International
Investors: |
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323-794-2551 |
Conference ID: |
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3511679 |
Webcast: |
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https://edge.media-server.com/m6/p/f7whg6sk |
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About the GLOBE studyThe GLOBE pivotal Phase 3
trial is a randomized, controlled, double-arm, open-label study of
VB-111 dosed every two months in combination with bevacizumab dosed
every two weeks, compared to bevacizumab monotherapy. Key inclusion
criteria include first or second progression of glioblastoma
following standard of care treatment with temozolomide and
radiation, a histologically confirmed diagnosis of glioblastoma and
measurable disease by RANO criteria at progression.
The study is conducted 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.
About Glioblastoma (GBM)GBM is the most common
and most aggressive form of primary brain tumors. In 2017, it is
estimated there were approximately 12,000-13,000 new cases
diagnosed in the United States. Median 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 VB-111 (ofranergene obadenovec)VB-111, a
potential first-in-class anticancer therapeutic candidate, is the
Company’s lead oncology product currently being studied in a Phase
3 trial for ovarian cancer. VB-111 has demonstrated statistically
significant OS and PFS in a Phase 2 trial in patients with rGBM,
versus current standard of care. VB-111 has 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.
In addition, 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. VB-111 has received an Orphan Designation
for the treatment of ovarian cancer by the European Medicines
Agency (EMA).
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 demonstrated 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
trial for platinum-resistant ovarian cancer.
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 projected
cash resources and the clinical development of ofranergene
obadenovec (VB-111), including our expectations for its therapeutic
potention in any other future indications we may study. 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. 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.
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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