GW Pharmaceuticals Achieves Positive Results in Phase 2 Proof of Concept Study in Glioma
February 07 2017 - 7:00AM
- GW intends to advance oncology research
and development efforts -
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.
Enquiries:
GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations
401 500 6570
Sam Brown Inc. Healthcare Communications
(U.S. Media Enquiries)
Mike Beyer
312 961 2502
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