GW Pharmaceuticals Initiates Phase 2 Clinical Study of Cannabidivarin (CBDV) in Epilepsy
May 06 2015 - 7:00AM
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 2 clinical trial of GWP42006 in adult patients
with epilepsy. GWP42006 is the non-psychoactive cannabinoid
cannabidivarin (CBDV) extracted from the cannabis plant.
"The start of this Phase 2 CBDV study represents another
important milestone for GW's research in the field of epilepsy,"
stated Justin Gover, GW's Chief Executive Officer. "While much of
the recent attention regarding GW has been associated with our
Epidiolex childhood epilepsy program which has now advanced into
Phase 3 trials, we believe that CBDV represents an additional
product pipeline opportunity as a next-generation epilepsy therapy.
GW has completed significant pre-clinical work on CBDV as well as a
Phase 1 trial which demonstrated a reassuring safety profile, and
we look forward to progressing this Phase 2 trial during 2015."
This study is a two-part, Phase 2, double blind, randomized,
placebo controlled study. Part A is designed to investigate the
pharmacokinetics, safety and tolerability of GWP42006 compared with
placebo in 30 patients, as add-on therapy in patients with
inadequately controlled focal seizures. Part B will evaluate the
efficacy of GWP42006 compared with placebo in 100 patients, as
add-on therapy to treat inadequately controlled focal seizures.
This study follows completion of a Phase 1 trial in 66 healthy
subjects in 2014. In this trial, CBDV was well tolerated even at
the highest tested dose and no significant side effects were
observed. There were no serious or severe adverse events, nor any
withdrawals due to adverse events.
GW's patent portfolio related to CBDV includes a granted patent
in Great Britain for the use of CBDV in the treatment of epilepsy
and a Notice of Allowance for the corresponding application with
the U.S. Patent and Trademark Office (USPTO) covering CBDV alone or
in combination with standard anti-epileptic drugs. The issued
patent from this application will provide an exclusivity period
until 30 March 2031. In total, GW has four patent families with
claims related to the use of CBDV in the treatment of epilepsy and
CBDV in combination with CBD in the treatment of epilepsy, as well
as compositions, extraction techniques, and CBDV extracts.
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 27 countries
outside the United States. GW is advancing an orphan drug program
in the field of childhood epilepsy with a focus on Epidiolex®,
which is in Phase 3 clinical development for the treatment of
Dravet syndrome and which is also expected to enter Phase 3
clinical trials in the treatment of Lennox-Gastaut syndrome and
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, 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 benefit, safety profile and
commercial value of the company's investigational product
candidates, the development and commercialization of such product
candidates, 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.
CONTACT: 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
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