GW Pharmaceuticals PLC IND for Epidiolex Ph 2/3 Trial in Dravet Syndrome (4110G)
May 07 2014 - 2:00AM
UK Regulatory
TIDMGWP
RNS Number : 4110G
GW Pharmaceuticals PLC
07 May 2014
GW Pharmaceuticals Receives Investigational New Drug (IND) from
FDA for Phase 2/3 Clinical Trial of Epidiolex(R) in the Treatment
of Dravet Syndrome
London, UK; 7 May 2014: 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, today announced that the Company has received
confirmation from the U.S. Food and Drug Administration (FDA) that
its Investigational New Drug application (IND) is now open for
Epidiolex in the treatment of Dravet Syndrome, a rare and
catastrophic treatment-resistant form of childhood epilepsy. GW
expects to commence a Phase 2/3 clinical trial in the second half
of 2014.
Epidiolex has already received orphan drug designation from the
FDA for the treatment of Dravet syndrome.
"The acceptance of this IND by the FDA is a significant
milestone for Epidiolex and for children with Dravet syndrome for
whom existing anti-epileptic medicines often do not provide
adequate relief," stated Justin Gover, GW's Chief Executive
Officer. "This journey began with requests from the U.S. epilepsy
physician and patient community to utilize Epidiolex and has now
led to GW embarking on its own formal development program with a
view to seeking market authorization from the FDA as rapidly as
possible. We are committed to providing a prescription cannabidiol
(CBD) medicine for children with Dravet syndrome who have exhausted
all other therapeutic options."
The Phase 2/3 trial is a two-part randomized double-blind,
placebo-controlled parallel group dose escalation, safety,
tolerability, pharmacokinetic and efficacy trial of single and
multiple doses of Epidiolex to treat Dravet syndrome in children
who are being treated with other anti-epileptic drugs. Part one
comprises the pharmacokinetic and dose-finding elements of the
trial in a total of 30 patients over a 3 week treatment period.
Part two is a placebo-controlled safety and efficacy evaluation of
Epidiolex over a 3 month treatment period in a total of 80
patients. All patients who participate in the study will be
eligible to receive Epidiolex under a long term open label
extension protocol.
GW anticipates commencing an additional Phase 3 trial in Dravet
syndrome in the first quarter of 2015 in parallel with part two of
the first Phase 2/3 trial.
In addition to Dravet syndrome, GW plans to conduct a clinical
development program for Epidiolex in the treatment of
Lennox-Gastaut syndrome (LGS). Following receipt earlier in 2014 of
orphan drug designation by the FDA in LGS, GW expects to hold a
pre-IND meeting with the FDA for Epidiolex in the treatment of LGS
in mid-2014, and aims to conduct two Phase 3 trials in LGS during
2015.
About Dravet syndrome
Dravet syndrome, also known as Severe Myoclonic Epilepsy of
Infancy (SMEI), is a rare and catastrophic form of epilepsy for
which there is currently no cure. Seizures begin in the first year
of life in an otherwise typically developing infant. Initial
seizures are most often prolonged events (status epilepticus) and,
in the second year of life, other seizure types emerge. All seizure
types are remarkably resistant to medical therapy and the prognosis
for Dravet syndrome is poor. Individuals with Dravet syndrome face
a higher incidence of SUDEP (sudden unexplained death in epilepsy)
and have associated co-morbid conditions, which also need to be
properly managed. Children with Dravet syndrome do not outgrow this
condition and it affects every aspect of their daily lives.
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 25
countries. Sativex is also in Phase 3 clinical development as a
potential treatment of pain in people with advanced cancer. This
Phase 3 program is intended to support the submission of a New Drug
Application for Sativex in cancer pain with the U.S. Food and Drug
Administration and in other markets around the world. GW has a deep
pipeline of additional cannabinoid product candidates, including
Epidiolex which has received Orphan Drug Designation from the FDA
for the treatment of Dravet and Lennox-Gastaut syndromes, severe,
drug-resistant epilepsy syndromes. GW's product pipeline also
includes compounds in Phase 1 and 2 clinical development for
glioma, ulcerative colitis, 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 and commercial value of the
company's compounds including 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
Justin Gover, Chief Executive Officer (Thereafter) + 44 1980
557000
Stephen Schultz, VP Investor Relations
(US) 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway / John Dineen
(UK) + 44 20 3727 1000
Robert Stanislaro (US) 212 850 5657
Trout Group, LLC (US 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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