VBL Therapeutics (Nasdaq:VBLT) today announced the study initiation
and first patient in its Phase 3 pivotal registration trial, OVAL,
studying its lead candidate VB-111 (ofranergene obadenovec) in
platinum-resistant ovarian cancer. The OVAL study will be conducted
in collaboration with the Gynecologic Oncology Group (GOG)
Foundation, Inc., a leading organization for research excellence in
the field of gynecologic malignancies.
“There is a tremendous need for effective treatments for women
with platinum resistant and refractory ovarian cancer, estimated at
50,000 cases in the United States, for whom therapeutic options
often fail to prolong survival. We are excited to be working with
the GOG, a standard-setting organization for clinical research on
pelvic malignancies, in addressing this important medical need,"
said Dror Harats, MD, chief executive officer of VBL
Therapeutics.
"GOG is an organization dedicated to clinical research in the
field of gynecologic cancer. Interest in the VB-111 development
program is based on positive clinical data generated using this
agent, including the Phase 2 study that VBL completed in ovarian
cancer, which showed a high response rate and better survival with
the therapeutic dose of VB-111," said Richard Penson, MD,
MRCP, associate professor of Medicine, Harvard Medical School,
clinical director of Medical Gynecologic
Oncology, Massachusetts General Hospital, Primary Investigator
for the VB-111 Phase 2 trial and the Principal Investigator of the
new OVAL study.
In December 2016, VBL held an End-of-Phase 2 meeting with the
U.S. Food and Drug Administration (FDA) to discuss the clinical
path forward for VB-111 in ovarian cancer. The company has reached
an agreement with the agency on the VB-111 Phase 3 pivotal study in
platinum-resistant patients, with overall survival as the primary
endpoint.
The randomized, controlled, Phase 3 OVAL study in recurrent
platinum-resistant ovarian cancer has been designed to enroll up to
350 adult patients at approximately 70 clinical sites in the United
States and Israel. Patients will be randomized 1:1 to VB-111 in
combination with chemotherapy, or chemotherapy alone. The primary
endpoint is overall survival. Additional endpoints include
objective response rate (ORR), progression free survival (PFS),
combined CA-125 and RECIST 1.1 response (GCIG criteria) and patient
reported outcome measures.
At the 2016 ASCO, the company presented data in
platinum-resistant ovarian cancer, demonstrating a meaningful and
significant increase in overall survival with VB-111 given in
combination with chemotherapy (810 days vs. 172 days, p=0.042),
along with a 60% durable CA-125 response rate—approximately two
times the historical response observed with bevacizumab (Avastin®)
plus chemotherapy in ovarian cancer.
VB-111 is also being studied in the GLOBE Phase 3 pivotal trial
for recurrent glioblastoma (rGBM), conducted under an FDA Special
Protocol Assessment (SPA), with top-line data expected in the first
quarter of 2018.
About Gynecologic Oncology Group (GOG)
Foundation, Inc.
(www.gog.org) The GOG
Foundation, Inc. is a not-for-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. The GOG is committed to maintaining the highest
standards in clinical trials development, execution, analysis and
distribution of results. The GOG is the only group in the United
States that focuses its research on women with pelvic malignancies,
such as cancer of the ovary, uterus and cervix. The GOG is
multi-disciplinary in its approach to clinical trials, and includes
gynecologic oncologists, medical oncologists, pathologists,
radiation oncologists, nurses, statisticians, basic scientists,
quality of life experts, data managers and administrative
personnel.
About VB-111 (Ofranergene Obadenovec)
Lead candidate VB-111 is a first-in-class anticancer targeted
gene therapy-based biologic that has demonstrated statistically
significant long-term survival in patients, and offers broad
potential to treat a wide range of cancers. VB-111 harnesses
natural processes in the body to target tumors by employing a dual
mechanism – a proprietary anti-angiogenic gene therapy that leads
to targeted elimination of the tumor’s blood supply, and a viral
immuno-oncology mechanism that educates the immune system to fight
the tumor.
After demonstrating statistically significant overall survival
(OS) and a PFS benefit in a Phase 2 trial in patients with rGBM,
VB-111 is currently being studied in a Phase 3 pivotal trial for
rGBM under a SPA with the FDA. VB-111 has received Fast Track
designation from the FDA in the US for significant prolongation of
survival in patients with rGBM, and Orphan Drug designation for
treatment of GBM in both the US and Europe. VB-111 also has
received an Orphan Designation for the treatment of ovarian cancer
by the European Medicines Agency (EMA), and a Phase 3 study of
VB-111 in ovarian cancer has now commenced. VBL intends to
launch an exploratory Phase 1/2 study in non-small cell lung cancer
(NSCLC), in combination with a checkpoint inhibitor, in the first
quarter of 2018.
VB-111 is conveniently administered as an IV infusion once every
two months. It has been observed to be well-tolerated in more than
300 cancer patients and has demonstrated efficacy signals in an
“all comers” Phase 1 trial, as well as in three tumor-specific
Phase 2 studies.
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, VB-111, is a
first-in-class, targeted anti-cancer gene-therapy biologic with
broad potential to treat a wide range of solid tumors. Earlier this
year VBL opened its new gene therapy manufacturing plant in Modiin,
Israel. This plant will be the commercial facility for production
of the Company’s lead product candidate. The Modiin facility is the
first commercial-scale gene therapy manufacturing facility in
Israel and currently one of the largest gene-therapy designated
ones in the world (20,000 sq. ft.).
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 about our cash position
and resources, statements regarding the clinical development of
VB-111, including our expectations regarding the timing of results
from the OVAL and GLOBE studies, 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 VB-111 in rGBM and other
indications may not support approval of VB-111 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 Dec. 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 MiddlemanLifeSci Public
Relations(646) 627-8384
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