GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW” or “the
Company”), a biopharmaceutical company focused on discovering,
developing and commercializing novel therapeutics from its
proprietary cannabinoid product platform, today announced that it
has commenced a Phase 3 clinical trial of Epidiolex® (cannabidiol
or CBD) as an adjunctive therapy for the treatment of seizures
associated with Tuberous Sclerosis Complex (TSC), a rare genetic
disorder, the most common symptom of which is epilepsy. Epilepsy
occurs in around 80-90% of TSC patients and is a significant cause
of morbidity and mortality. TSC is the third indication that GW is
targeting within its Epidiolex clinical development program, which
includes four Phase 3 pivotal trials in Dravet syndrome and
Lennox-Gastaut syndrome, both rare and catastrophic forms of
childhood-onset epilepsy. On March 14, 2016, GW announced positive
results from the first of these pivotal trials in Dravet syndrome.
“We are pleased to announce the start of this
pivotal clinical trial of Epidiolex in TSC, which follows the
recent positive results from our trial in patients with Dravet
syndrome. Our decision to evaluate Epidiolex in TSC is based on
findings from the physician-led Epidiolex expanded access program,
which found that TSC patients reported reductions in seizure
activity,” stated Justin Gover, GW’s Chief Executive Officer. “With
the commencement of this trial, GW’s Epidiolex development program
now encompasses three rare epilepsy indications with pivotal trials
fully underway. GW is committed to establishing Epidiolex as a new
therapy to address the significant unmet need among patients who
have few treatment options.”
“In patients with TSC, epilepsy is common,
presents early and can become more difficult to treat over time.
The results of our open-label study of Epidiolex in children with
TSC have been very encouraging and we are excited to begin this
important placebo-controlled clinical trial,” stated Elizabeth
Thiele, MD, PhD, Director, Pediatric Epilepsy Program at
Massachusetts General Hospital, Director, Herscot Center for
Tuberous Sclerosis Complex and Professor of Neurology, Harvard
Medical School and Principal Investigator of the trial. “As one of
the largest TSC treatment centers in the country, our focus has
always been on finding new and innovative solutions that improve
the lives of people living with TSC.”
At the 69th Annual Meeting of the American
Epilepsy Society in December 2015, safety and efficacy data on 10
patients diagnosed with TSC from the physician-led open-label
Epidiolex expanded access program were presented by Massachusetts
General Hospital for Children (Geffrey et al 2015) on Epidiolex
treatment of refractory epilepsy in these patients. The percent of
patients who reported a 50% or greater reduction in seizures were
50%, 50%, 40%, 60% and 66% at 2, 3, 6, 9, and 12 months of
treatment with Epidiolex, respectively. Side effects were seen in
five patients (50%) and most were resolved with anti-epileptic drug
or CBD dose adjustment.
This single Phase 3 dose-ranging trial is a
16-week comparison of Epidiolex versus placebo in a total of
approximately 200 patients, aged one to 65, to assess its safety
and efficacy as an adjunctive anti-epileptic treatment. The primary
measure of this trial is the percentage change from baseline in
seizure frequency during the treatment period. Primary endpoint
seizures include focal motor seizures with or without impairment of
consciousness or awareness and generalized convulsive seizures.
Several additional efficacy and safety secondary outcome measures
will be analysed. Following completion of the study, patients may
be eligible to receive Epidiolex through a long term open-label
extension study.
To obtain information about this clinical trial
or eligibility criteria, the treating physician should contact:
medicaldirector@gwpharm.com
About Tuberous Sclerosis Complex
(TSC)
Tuberous Sclerosis Complex (TSC) is a genetic
disorder that causes non-malignant tumors to form in many different
organs, with the brain and skin being the most commonly affected
tissues. There are approximately 50,000 in the United States and
nearly 1 million people worldwide estimated to have TSC1. Epilepsy
is the most common presenting symptom in TSC and is also the most
common medical disorder in TSC. Up to 80 to 90% of individuals with
TSC will develop epilepsy during their lifetime, with onset
typically in childhood. The majority of children with TSC have
onset of seizures during the first year of life, and up to one
third of children with TSC will develop infantile spasms. Almost
all seizure types can be seen in individuals with Tuberous
Sclerosis Complex, including tonic, clonic, tonic-clonic, atonic,
myoclonic, atypical absence, partial, and complex partial. The
seizures are often severe, and up to two-thirds of TSC patients do
not respond adequately to available medical therapies. There are
significant co-morbidities associated with TSC including cognitive
impairment, autism spectrum disorders, and neurobehavioral
disorders in individuals with TSC.2
References:1: http://www.tsalliance.org/pages.aspx?content=5852:
http://www.medscape.com/viewarticle/495644
About Epidiolex
Epidiolex, GW’s lead cannabinoid product
candidate, is a liquid formulation of pure plant-derived CBD, which
is in development for the treatment of a number of rare pediatric
epilepsy disorders. GW has conducted extensive pre-clinical
research of CBD in epilepsy since 2007. This research has shown
that CBD has significant anti-epileptiform and anticonvulsant
activity using a variety of in vitro and in vivo models and has the
ability to treat seizures in acute animal models of epilepsy with
significantly fewer side effects than existing anti-epileptic
drugs. To date, GW has received Orphan Drug Designation from the
U.S. Food and Drug Administration (FDA) for Epidiolex in the
treatment of both Dravet syndrome and Lennox-Gastaut syndrome.
Additionally, GW has received Fast Track Designation from the FDA
and Orphan Designation from the European Medicines Agency for
Epidiolex for the treatment of Dravet syndrome. GW is currently
evaluating additional clinical development programs in other orphan
seizure disorders.
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 commercialized the
world’s first plant-derived cannabinoid prescription drug,
Sativex®, which is approved for the treatment of spasticity due to
multiple sclerosis in 28 countries outside the United States. 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 and Tuberous Sclerosis Complex. GW has a
deep pipeline of additional cannabinoid product candidates which
includes compounds in Phase 1 and 2 trials for glioma, type 2
diabetes, schizophrenia and epilepsy. For further information,
please visit www.gwpharm.com.
Forward-looking statementsThis
news release may contain forward-looking statements that reflect
GWs current expectations regarding future events, including
statements regarding the therapeutic benefit, safety profile and
commercial value of the company's investigational drug Epidiolex®,
the development and commercialization of Epidiolex, plans and
objectives for product development, plans and objectives for
present and future clinical trials and results of such trials,
plans and objectives for regulatory approval. 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 the 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,
uncertainties and other risks associated with an investment in GW
can be found in GW’s filings with the U.S. Securities and Exchange
Commission. 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 (U.S.) |
917 280
2424 / 401 500 6570 |
|
|
FTI Consulting (Media Enquiries) |
|
Ben
Atwell / Simon Conway |
+ 44 20
3727 1000 |
|
|
FleishmanHillard (U.S. Media) |
|
Paddi
Hurley / Adam Silverstein |
212 453
2382 / 917 697 9313 |
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Mar 2024 to Apr 2024
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Apr 2023 to Apr 2024