VBL Therapeutics
VBLT, a late-stage clinical biotechnology company focused on the
discovery, development and commercialization of first-in-class treatments
for cancer, today announced top-line interim results from its ongoing Phase
2 study of VB-111 in patients with recurrent glioblastoma (rGBM), which
demonstrated a statistically significant improvement in overall survival in
patients treated with VB-111 followed by VB-111 in combination with
bevacizumab (Avastin(R)) upon disease progression, compared to patients
treated with VB-111 followed by bevacizumab alone upon disease progression
(p=0.05). Study results will be presented in conjunction with the American
Society of Cancer Oncology (ASCO) Annual Meeting, May 29th-June 2nd, 2015 in
Chicago, Illinois.
"We are extremely pleased by these interim results and are particularly
excited to see a statistically significant improvement in overall survival
in this needy patient population. We believe VB-111's ability to curb
disease progression in this devastating illness further reinforces its broad
potential as a gene therapy for a range of solid tumor indications," said
Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We continue
to work to bring VB-111 forward as a potential new treatment option, and
look forward to initiating a pivotal Phase 3 trial in recurrent glioblastoma
later this year."
These interim Phase 2 data include 46 patients with rGBM. VB-111 monotherapy
was discontinued upon progression in 22 patients who were then treated with
bevacizumab alone. The remaining 24 patients, upon disease progression on
VB-111 monotherapy, could elect to receive further treatment with VB-111 in
combination with bevacizumab. 23 have received combined therapy; one patient
is still stable on VB-111 monotherapy at 424 days. VB-111 in combination
with bevacizumab demonstrated a statistically significant improvement in
overall survival, with median overall survival of 414 days, compared to 235
days in patients on VB-111 followed by bevacizumab alone (p=0.05).
VBL's pivotal Phase 3 clinical trial will be led by Dr. Timothy Cloughesy,
MD, Professor of Clinical Neurology and Director of the Neuro-Oncology
Program, UCLA School of Medicine and is expected to initiate in mid-2015
under a special protocol assessment granted by the FDA.
Study Details:
The Phase 1/2 trial is a multi-center, two stage, dose-escalation study
designed to determine the safety, tolerability and efficacy of VB-111 in
patients with rGBM. In the first stage of the study, patients were treated
with VB-111 alone. Upon disease progression -- defined according to the
Response Assessment in Neuro-Oncology (RANO) criteria as a worsening of the
patient's cancer with an increase of at least 25% in the overall mass of
measurable tumors, the appearance of new tumors, the worsening of
non-measurable tumors since the beginning of treatment, a need for increased
dose of corticosteroids, or clinical deterioration -- patients entered the
second stage in which they received either bevacizumab alone or bevacizumab
in combination with VB-111, in two sequential cohorts.
About VB-111:
VB-111 is a novel, intravenously-administered, anti-angiogenic agent that
utilizes VBL's proprietary Vascular Targeting System (VTS(TM)) to target
endothelial cells in the tumor vasculature for cancer therapy. VB-111
continues a non-replicating adenovector, a proprietary modified murine
pre-proendothelin promoter (PPE-1-3x) and a Fas-Chimera transgene to
angiogenic tumor blood vessels, leading to their apoptosis. VB-111 is the
first agent based on transcriptional targeting of tumor endothelium to be
assessed in a clinical trial.
VB-111 completed a Phase 1/2 "all-comers" clinical trial, which demonstrated
multiple cases of objective tumor response and disease control and excellent
safety and tolerability. VB-111 has Fast Track Designation for recurrent
glioblastoma in the US and organ drug status for glioblastoma in both the US
and EU. VBL is conducting early phase II studies in thyroid and ovarian
cancer.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in