GW Pharmaceuticals PLC Initiates Ph3 Pivotal Study of Epidiolex in LGS (7605M)
11 May 2015 - 9:00PM
UK Regulatory
TIDMGWP
RNS Number : 7605M
GW Pharmaceuticals PLC
11 May 2015
GW Pharmaceuticals Initiates Phase 3 Pivotal Study of
Epidiolex(R) (CBD) in Lennox-Gastaut Syndrome
London, UK, 11 May 2015: GW Pharmaceuticals plc (Nasdaq: GWPH,
AIM: GWP, "GW," "the Company" or "the Group"), a biopharmaceutical
company focused on discovering, developing and commercializing
novel therapeutics from its proprietary cannabinoid product
platform, announced that it has commenced a Phase 3 clinical trial
of Epidiolex(R) (cannabidiol or CBD) for the treatment of
Lennox-Gastaut syndrome (LGS), a rare and severe form of
childhood-onset epilepsy. During 2014, GW received Orphan Drug
Designation from the U.S. Food and Drug Administration (FDA) for
Epidiolex for the treatment of LGS. GW anticipates that top-line
data from this trial will be available in early 2016.
"The commencement of this Phase 3 pivotal trial of Epidiolex in
Lennox-Gastaut syndrome follows on from the recent start of two
Phase 3 pivotal trials of Epidiolex in Dravet syndrome and
represents another important milestone towards our planned
submission of a NDA to the FDA in 2016," stated Justin Gover, GW's
Chief Executive Officer. "Although there are approved treatments
available for patients with Lennox-Gastaut syndrome, this severe
form of epilepsy often remains particularly difficult to treat. We
believe that Epidiolex has the potential to meet this significant
unmet need."
This Phase 3 pivotal trial is a randomized, double-blind,
14-week comparison of Epidiolex versus placebo in a total of 150
patients to assess the dose-ranging safety and efficacy of
Epidiolex as an adjunctive antiepileptic treatment. The treatment
period will consist of a two-week titration period followed by a
12-week maintenance period. This Phase 3 trial will have three arms
of 50 patients; 20mg/kg and 10mg/kg of Epidiolex and placebo. The
primary measure of this trial will be the percentage change from
baseline in number of drop seizures in patients taking Epidiolex
versus placebo. Several additional efficacy and safety secondary
outcome measures will be analysed. Following their participation in
the study, all patients are eligible to receive Epidiolex under a
long term open label extension study.
LGS usually begins before 4 years of age, and can be caused by a
number of conditions, including brain malformations, severe head
injuries, central nervous system infections, and inherited
degenerative or metabolic conditions. In 30 to 35 percent of
patients, no cause can be found. Patients commonly have frequent
seizures of a wide variety, including convulsive, atonic seizures
(brief loss of muscle tone and consciousness, causing abrupt
falls). Drug resistance is one of the main features of LGS. Most
children with LGS experience some degree of impaired intellectual
functioning or information processing, as well as developmental
delays and behavioral disturbances. It is estimated that there are
approximately 14,000-18,500 patients with LGS in the United States
and 23,000-31,000 patients with LGS in Europe.
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 27
countries outside the United States. GW is advancing an orphan drug
program in the field of childhood epilepsy with a focus on
Epidiolex(R) , which is in Phase 3 clinical development for the
treatment of Dravet syndrome and Lennox-Gastaut syndrome and which
is also expected to enter Phase 3 clinical trials in the treatment
of Tuberous Sclerosis Complex. GW has a deep pipeline of additional
cannabinoid product candidates which includes Sativex in Phase 3
clinical development as a potential treatment of pain associated
with advanced cancer, as well as compounds in Phase 1 and 2 trials
for glioma, type 2 diabetes, and schizophrenia. 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 (Today) +44 20 3727 1000
Stephen Schultz, VP Investor Relations
(U.S.) 917 280 2424 / 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway / John
Dineen (UK) + 44 20 3727 1000
Robert Stanislaro (U.S.) 212 850 5657
Trout Group, LLC (U.S. investor
relations)
Todd James / Chad Rubin 646 378 2900
Peel Hunt LLP (UK NOMAD)
James Steel / Clare Terlouw +44 20 7418 8900
This information is provided by RNS
The company news service from the London Stock Exchange
END
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