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RNS Number : 7676U
GW Pharmaceuticals PLC
11 April 2016
GW Pharmaceuticals Initiates Phase 3 Pivotal Study in Tuberous
Sclerosis Complex
London, UK, 11 Apr 2016: 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(R) (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 69(th) 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 TSC(1) . 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=585
2: 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(R), 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(R) (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 statements
This 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(R), 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(R), Epidiolex(R), 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
Peel Hunt LLP (UK NOMAD)
James Steel +44 20 7418 8900
This information is provided by RNS
The company news service from the London Stock Exchange
END
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