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RNS Number : 6635B
GW Pharmaceuticals PLC
08 January 2015
GW Pharmaceuticals and Otsuka Announce Results in First of Three
Sativex(R) Phase 3 Cancer Pain Trials
- Primary endpoint did not show a statistically significant
difference for Sativex compared with placebo in reducing pain-
Conference call and webcast with GW management scheduled at 8:00
a.m. EST, 1:00 p.m. GMT to discuss this and the Epidiolex(R) press
release issued today
London, UK and Princeton, NJ, US, 8 January 2015: GW
Pharmaceuticals plc (NASDAQ: GWPH, AIM: GWP, "GW,") and Otsuka
Pharmaceutical Development & Commercialization, Inc., today
reported the top-line results from the first of three Phase 3
trials for the investigational product Sativex(R) in the treatment
of pain in patients with advanced cancer who experience inadequate
analgesia during optimized chronic opioid therapy. In this first
trial, Sativex (as adjunctive treatment to optimized chronic opioid
therapy) did not meet the primary endpoint of demonstrating a
statistically significant difference from placebo.
"Although we missed the primary endpoint in this trial, based
upon the positive data seen in the Phase 2 program, we remain
confident in the ability for Sativex to relieve cancer pain in this
patient population", stated Justin Gover, GW's Chief Executive
Officer. "We have two additional pivotal Phase 3 trials ongoing
which, if positive, would still allow us to submit a New Drug
Application with the US FDA. We look forward to results from these
two further studies later this year."
Efficacy
The primary efficacy measure of the study was a patient
assessment of pain using a 0-to-10 Numeric Rating Scale (NRS) which
was analysed using percent improvement from baseline as the primary
analysis. In addition, improvement was also analysed using a
cumulative proportion of responders analysis (CPRA), which analyses
the full range of responses achieved across the entire patient
population within a trial. In this trial, these analyses did not
show a statistically significant difference between Sativex and
placebo. The secondary endpoints followed the pattern of the
primary endpoint. In this study, the United States was the largest
single recruiting country. Although not statistically significant,
the efficacy data from U.S. sites showed more positive trends than
those in non-U.S. sites. This is consistent with data from the
Phase 2b trial.
Safety
The safety profile of Sativex in this Phase 3 trial was
consistent with previous studies in this patient population.
Overall, Sativex was well tolerated. The only adverse events
reported at greater than 10% for the Sativex population were
neoplasm progression (16% on Sativex vs 18% on placebo) and
somnolence (12% on Sativex vs 4% on placebo). The other most
frequently reported adverse event on Sativex was dizziness (8% on
Sativex vs 5% on placebo). Otherwise, there was little difference
in the adverse event pattern between Sativex and placebo. There
were 38 (19%) withdrawals due to adverse events on Sativex compared
with 29 (15%) on placebo.
Commenting on the results, Dr. Marie Fallon, Professor of
Palliative Care, University of Edinburgh and the principal
investigator stated, "We believe that cannabinoid therapy offers a
potentially novel approach as a co-analgesic to provide pain relief
beyond opioid therapy. Too many patients with advanced cancer do
not attain adequate pain relief from an opioid regimen, or
experience unacceptable opioid side effects. Whilst I am naturally
disappointed that this first trial did not achieve its primary
endpoint, I remain optimistic about the potential of Sativex and
look forward to the upcoming data from the remaining Sativex Phase
3 trials later this year."
Phase 3 Trial Design
This randomized double-blind placebo-controlled parallel-group
study recruited a total of 399 patients at clinical sites in the
U.S., Mexico and Europe. This trial evaluated Sativex at a dose
range of 3-to-10 sprays per day over a 5-week treatment period with
an additional 5-to-14 day stabilization period at the beginning of
the trial and a one--week follow--up at the end of the trial.
Patients received the active investigational agent or placebo as
add-on treatment to optimized opioid therapy and remained on stable
doses of their background opioid therapy during the study.
Following completion of the randomized phase, all patients were
eligible to enter a long--term extension trial.
This study is the first of three Phase 3 trials carried out by
GW and Otsuka as part of the development program aimed at securing
regulatory approval for Sativex in cancer pain from the FDA and
other regulatory authorities around the world.
A second Phase 3 pivotal trial, identical to the first, is
expected to report top line results in the second quarter of 2015.
GW and Otsuka are also in the process of conducting a third Phase 3
trial, which is expected to enroll approximately 540 patients and
designed to provide additional information on the effects of
Sativex in treating opioid-resistant cancer pain. The third Phase 3
trial differs in design from the first two trials, employing a
two--part "enriched trial design" akin to that which was
successfully employed in the Sativex MS spasticity trials program
in Europe. The results of this third trial are expected towards the
end of 2015. GW will continue to be the holder of the IND until the
filing of a New Drug Application, which will be in Otsuka's
name.
Phase 2 Data
Sativex has previously completed a Phase 2b dose ranging study
and Phase 2a study. In these prior studies, Sativex showed
statistically significant improvements versus placebo using the
same primary measure as in the Phase 3 trial.
Sativex in Multiple Sclerosis
Sativex is approved for the treatment of spasticity due to
multiple sclerosis in 27 countries outside the U.S. In the U.S., a
request for Special Protocol Assessment has been submitted to the
FDA for a proposed single Phase 3 study in this indication.
Conference Call and Webcast Information
GW will host a conference call at 8:00 a.m. EST, 13:00 GMT
today, January 8 2015, to comment on the Sativex results. To
participate in the call, please dial (877) 407-8133 within the
U.S., (201) 689-8040 from outside the U.S. or toll free from the
U.K.: 0 800 756 3429. A replay of the call will be made available
for a period of two weeks following the conference call. To hear a
replay of the call dial (877) 660-6853 (inside the U.S.) or (201)
612-7415 (outside the U.S.). A replay of the call will also be
available via the company's website shortly after the call. For
both dial-in numbers please use conference ID 13598599. The
conference call can also be heard live via the investor relations
section of the Company's website at www.gwpharm.com.
About Otsuka
Otsuka Pharmaceutical Development & Commercialization, Inc.
(OPDC), based in Princeton, New Jersey and Rockville, Maryland,
discovers and develops new compounds that address urgent,
unanswered medical needs. OPDC has numerous compounds in
development to treat disorders in the neuroscience, oncologic, and
cardio-renal therapeutic areas. OPDC is part of the Otsuka Group
companies. For more information about OPDC, visit
www.otsuka-us.com.
At a global level, Otsuka Pharmaceutical Co., Ltd. contributes
to the advancement of human health through its leading position in
the challenging field of mental health and through research
programs in areas such as tuberculosis, a significant global public
health issue, and in ADPKD.
The company has a long history of individualistic thinking and
perseverance in the disease areas it enters into, illustrating more
powerfully than words how Otsuka is a "big venture" company at
heart, applying a youthful spirit of creativity in everything it
does.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of
Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group
that is headquartered in Tokyo and whose origins date from 1921.
The Otsuka Group has business operations in 27 countries and
regions around the world, with consolidated sales of approximately
USD 14.1 billion for fiscal year 2013 (4/1/2013-3/31/2014.) Otsuka
welcomes you to visit its global website at
https://www.otsuka.co.jp/en.
About GW Pharmaceuticals
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. Sativex is also in Phase 3
clinical development as a potential treatment of pain associated
with advanced cancer. GW is also advancing an orphan drug program
in the field of childhood epilepsy with a focus on Epidiolex(R),
which is in Phase 2/3 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. GW has
a deep pipeline of additional cannabinoid product candidates which
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 contains forward-looking statements that
reflect GW's current expectations regarding future events,
including statements regarding financial performance, the timing of
clinical trials, the relevance of GW products commercially
available and in development, the clinical benefits of Sativex(R)
and Epidiolex(R) and the safety profile and commercial potential of
Sativex and Epidiolex. 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 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 and uncertainties 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.
Contacts
For Investors For Media
Contacts at GW Stephen Schultz FTI Consulting
Pharmaceuticals + 1 401 500 6570 Ben Atwell /Simon Conway
sschultz@gwpharm.com (UK)
+ 44 20 3727 1000
Peel Hunt LLP (UK NOMAD) Robert Stanislaro (US)
James Steel / Clare + 1 212 850 5657
Terlouw
+ 44 20 7418 8900
Contact at Rose Weldon
Otsuka America + 1 215 801 7644
Pharmaceutical, rose.weldon@otsuka-us.com
Inc.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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