Feb 7, 2017
- GW intends to advance oncology research and development efforts -
LONDON,
Feb. 07, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc
(Nasdaq:GWPH) ("GW," "the Company" or "the Group"), a biopharmaceutical
company focused on discovering, developing and commercializing novel
therapeutics from its proprietary cannabinoid product platform, today
announced positive top-line results from an exploratory Phase 2
placebo-controlled clinical study of a proprietary combination of
tetrahydrocannabinol (THC) and cannabidiol (CBD) in 21 patients with
recurrent glioblastoma multiforme, or GBM. GBM is a particularly
aggressive brain tumor, with a poor prognosis. GW has received Orphan
Drug Designation from the U.S. Food and Drug Administration (FDA) and
the European Medicines Agency (EMA) for THC:CBD in the treatment of
glioma.
The study showed that patients with
documented recurrent GBM treated with THC:CBD had an 83 percent one year
survival rate compared with 53 percent for patients in the placebo
cohort (p=0.042). Median survival for the THC:CBD group was greater than
550 days compared with 369 days in the placebo group. THC:CBD was
generally well tolerated with treatment emergent adverse events leading
to discontinuation in two patients in each group. The most common
adverse events (three patients or more and greater than placebo) were
vomiting (75%), dizziness (67%), nausea (58%), headache (33%), and
constipation (33%). The results of some biomarker analyses are still
awaited.
"The findings from this well-designed
controlled study suggest that the addition of a combination of THC and
CBD to patients on dose-intensive temozolomide produced relevant
improvements in survival compared with placebo and this is a good signal
of potential efficacy," said Professor Susan Short, PhD, Professor of
Clinical Oncology and Neuro-Oncology at Leeds Institute of Cancer and
Pathology at St James's University Hospital and principal investigator
of the study. "Moreover, the cannabinoid medicine was generally well
tolerated. These promising results are of particular interest as the
pharmacology of the THC:CBD product appears to be distinct from existing
oncology medications and may offer a unique and possibly synergistic
option for future glioma treatment."
"We believe
that the signals of efficacy demonstrated in this study further
reinforce the potential role of cannabinoids in the field of oncology
and provide GW with the prospect of a new and distinct cannabinoid
product candidate in the treatment of glioma," stated Justin Gover, GW's
Chief Executive Officer. "These data are a catalyst for the
acceleration of GW's oncology research interests and over the coming
months, we expect to consult with external experts and regulatory
agencies on a pivotal clinical development program for THC:CBD in GBM
and to expand our research interests in other forms of cancer."
The
study, designed to evaluate a number of safety and efficacy endpoints,
comprised an initial phase where the safety of THC:CBD in combination
with dose-intense temozolomide (an oral alkylating agent that is a
standard first-line treatment for GBM) was assessed in 2 cohorts of 3
patients each. Following a satisfactory independent safety evaluation,
the study then entered a randomized placebo-controlled phase where 12
patients were randomized to THC:CBD as add-on therapy compared with 9
patients randomized to placebo (plus standard of care).
Beginning
in 2007 and prior to initiating this study, GW conducted substantial
pre-clinical oncologic research on several cannabinoids in various forms
of cancer including brain, lung, breast, pancreatic, melanoma, ovarian,
gastric, renal, prostate and bladder. These studies have resulted in
approximately 15 publications and show the multi-modal effects of
cannabinoids on a number of the key pathways associated with tumor
growth and progression. Cannabinoids have been shown to promote
autophagy (the process of regulated self-degradation by cells) via
several distinct mechanisms, including acting on the AKT/mTOR pathway,
an important intracellular signalling pathway that is overactive in many
cancers.
In glioma, THC and CBD appear to act
via distinct signalling pathways. The combination of THC and CBD showed
good efficacy in various animal models of glioma, particularly when used
in combination with temozolomide. Initial in vitro studies
showed that the combined administration of THC and CBD led to a
synergistic reduction in the viability of U87MG glioma cells when
compared to the administration of each cannabinoid individually. The
co-administration of temozolomide with THC and CBD had further
synergistic effects, causing a significant reduction in cell viability.
These pre-clinical studies justified the initiation of the Phase 2
clinical study.
GW's portfolio of intellectual
property related to the use of cannabinoids in oncology includes a
number of issued patents and pending applications in both the U.S. and
Europe. This portfolio is designed to protect the use of various
cannabinoids individually or in combination, in the treatment of a
variety of oncology-specific disorders and product formulations.
About GBM
Gliomas
are tumors that arise from glial cells mainly in the brain but can also
be found within the spinal cord. Within the category of Glioma there
are multiple different tumor types. GBM is the most common Glioma and is
one of the most common primary brain tumors, accounting for 15.6% of
all primary brain tumors (Ostrom et al. 2013). They are also the most
aggressive with only 28.4% of patients surviving one year and only 3.4%
surviving to year five (Brodbelt et al. 2015). Studies of patients with
high-grade gliomas showed that headache was the most common initial
presenting symptom. These headaches can be persistent lasting more than
six months and are often associated with other symptoms, including
seizures, visual disturbances, cognitive impairment and nausea and
vomiting depending on the location and growth rate of the tumor.
About GW Pharmaceuticals plc
Founded
in 1998, GW is a biopharmaceutical company focused on discovering,
developing and commercializing novel therapeutics from its proprietary
cannabinoid product platform in a broad range of disease areas. GW is
advancing an orphan drug program in the field of childhood epilepsy with
a focus on Epidiolex® (cannabidiol), which is in Phase 3
clinical development for the treatment of Dravet syndrome,
Lennox-Gastaut syndrome, Tuberous Sclerosis Complex and Infantile
Spasms. GW commercialized the world's first plant-derived cannabinoid
prescription drug, Sativex® (nabiximols), which is approved
for the treatment of spasticity due to multiple sclerosis in 31
countries outside the United States. The Company has a deep pipeline of
additional cannabinoid product candidates which includes compounds in
Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further
information, please visit www.gwpharm.com.
Forward-looking statements
This
news release contains forward-looking statements that reflect GW's
current expectations regarding future events, including statements
regarding financial performance, the timing of clinical trials, the
timing and outcomes of regulatory or intellectual property decisions,
the relevance of GW products commercially available and in development,
the clinical benefits of Sativex® and Epidiolex® and the safety profile
and commercial potential of Sativex and Epidiolex. Forward-looking
statements involve risks and uncertainties. Actual events could differ
materially from those projected herein and depend on a number of
factors, including (inter alia), the success of GW's research
strategies, the applicability of the discoveries made therein, the
successful and timely completion of uncertainties related to the
regulatory process, and the acceptance of Sativex, Epidiolex and other
products by consumer and medical professionals. A further list and
description of risks and uncertainties associated with an investment in
GW can be found in GW's filings with the U.S. Securities and Exchange
Commission, including the most recent Form 20-F filed on 5 December
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. GW 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.