TIDMGWP
RNS Number : 6266W
GW Pharmaceuticals PLC
23 November 2010
SATIVEX(R) ENTERS PHASE III CLINICAL PROGRAMME IN CANCER
PAIN
Porton Down, UK; 23 November 2010: GW Pharmaceuticals plc (AIM:
GWP) today announces the initiation of the Phase III clinical
trials programme of Sativex(R) in the treatment of pain in patients
with advanced cancer, who experience inadequate analgesia during
optimized chronic opioid therapy. This indication represents the
initial target indication for Sativex in the United States.
The Phase III programme is being performed in conjunction with
GW's licensing partner for Sativex(R) in the US, Otsuka
Pharmaceutical Co. Ltd. The programme, which is fully funded by
Otsuka, includes two Phase III randomised placebo-controlled
multi-centre multinational trials as well as a long term extension
study. Each Phase III trial will include approximately 370 patients
and will evaluate the efficacy and safety of Sativex versus placebo
over a 5 week treatment period.
The primary efficacy measure of the Phase III trials is a
patient assessment of pain using a 0-10 Numeric Rating Scale (NRS),
and the primary analysis is the "continuous response analysis of
percent improvement from baseline" (an analysis of percent
improvement in pain across the spectrum of response levels). This
analysis has yielded statistically significant results in both the
Phase IIa and IIb trials and has been the key efficacy parameter
discussed in the product labeling of several recently approved
medicines in the US for pain. The dose range employed in the
studies is 3 - 10 sprays per day.
The Phase III programme follows the announcement earlier this
year of positive data from a Phase IIb trial. Since this time, GW
and Otsuka have met with the Food & Drug Administration (FDA)
at an "end of Phase II" clinical meeting to review the Phase II
clinical data and the Phase III trial design. GW and Otsuka are
also currently engaged in discussions with the FDA regarding other
aspects of the development plan.
Each of the Phase III trials is expected to recruit patients in
Europe, North America, Latin America and Asia. The first Phase III
trial site has now been initiated in Europe and the first patient
is expected to be recruited during December 2010. The principal
investigator of the first study is Dr. Russell K. Portenoy,
Chairman of the Department of Pain Medicine and Palliative Care at
Beth Israel Medical Center in New York City. The second Phase III
study is expected to commence in mid 2011.
The Phase IIb trial evaluated three dose ranges of Sativex(R) -
a low dose (1-4 sprays per day), mid dose (6-10 sprays per day),
and high dose (11-16 sprays per day) over a 5 week treatment
period. In this study, the continuous response analysis showed
statistically significant results in favor of Sativex for both the
Sativex(R) low and mid dose groups versus placebo (p=0.008 and
p=0.038, respectively). The low and mid dose Sativex(R) groups,
when combined, were also significantly superior to placebo for the
primary outcome measure (p=0.006) and for the important secondary
efficacy measure of reduction in sleep disruption (p=0.016).
The results of this Phase IIb dose ranging study were consistent
with a previous Phase IIa, 3-week clinical trial in 177 patients.
In this prior study, Sativex(R) showed a statistically significant
improvement versus placebo in the continuous response analysis of
improvement in average daily pain (p=0.044). This study was been
published in the Journal of Pain and Symptom Management1.
Dr. Stephen Wright, GW's R&D Director, said, "We are pleased
to have arrived at this important milestone in the development of
Sativex(R) for cancer pain. Sativex(R) aims to address the needs of
the many patients with advanced cancer who do not attain adequate
pain relief from an opioid regimen. We have completed two large
Phase II trials with positive results and look forward to working
with Otsuka on this comprehensive Phase III programme for
Sativex(R) in this important indication."
Sativex(R) is approved in the UK, Spain, Canada and New Zealand
as a treatment for Multiple Sclerosis (MS) spasticity and GW aims
to seek approval for Sativex(R) in this MS indication across Europe
and other selected markets. Cancer pain represents the initial
target indication for Sativex(R) in the US. It is intended that the
Phase III cancer pain data will also be used by GW for future
regulatory applications in this indication in Europe and around the
world.
1 Johnson J et al, Journal of Pain and Symptom Management, Vol
39, Issue 2, pp 167-179
Enquiries:
For GW:
GW Pharmaceuticals plc Today: +44 20 7831 3113
Dr Geoffrey Guy, Chairman Thereafter: + 44 1980 557000
Justin Gover, Managing
Director
Mark Rogerson, Press and Tel: + 44 7885 638810
PR
Financial Dynamics Tel: +44 20 7831 3113
Ben Atwell, John Dineen
Notes to Editors
Sativex(R)
Sativex(R) is an investigational new product composed primarily
of two cannabinoids: CBD (cannabidiol,) and THC (delta 9
tetrahydrocannabinol). Sativex(R) is administered as a metered dose
oro-mucosal spray each 100uL spray contains 2.7mg THC and 2.5mg
CBD. The Sativex(R) formulation is standardized by both composition
and dose and is supplied in small spray vials. The components of
Sativex(R) have been shown to bind to cannabinoid receptors that
are distributed throughout the central nervous system and in immune
cells.
Cancer pain represents the initial target indication for
Sativex(R) in the US. Sativex(R) is approved in the UK, Spain,
Canada and New Zealand as a treatment for Multiple Sclerosis
spasticity.
Cancer Pain
Studies suggest that more than one-third of patients with
cancer, and more than three-quarters of those with advanced
disease, have chronic pain. Large surveys indicate that optimal
opioid therapy does not yield sufficient relief in a substantial
proportion of these patients.
About GW-Otsuka
In February 2007, GW and Otsuka entered into a major long term
strategic alliance. The relationship commenced with the signing of
an exclusive license agreement to develop and market Sativex(R),
GW's lead product, in the US. In July 2007, GW and Otsuka signed a
global research collaboration for the study of cannabinoids in the
field of Central Nervous System (CNS) and oncology to research,
develop and commercialize a range of candidate cannabinoid
products.
About Otsuka Pharmaceutical Co., Ltd
Founded in 1964, Otsuka Pharmaceutical Co.,Ltd. is a global
healthcare company with the corporate philosophy 'Otsuka-people
creating new products for better health worldwide.' Otsuka
researches, develops, manufactures and markets innovative and
original products, with a focus on pharmaceutical products for the
treatment of diseases, and consumer products for the maintenance of
everyday health. Otsuka is committed to being a corporation that
creates global value, adhering to high ethical standards required
of a company involved in human health and life, maintaining a
dynamic corporate culture, and working in harmony with local
communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of
Otsuka Holdings Co., Ltd., the holding company for the Otsuka
Group. The Otsuka Group comprises 145 companies and employs
approximately 39,000 people in 23 countries and regions worldwide.
Otsuka and its consolidated subsidiaries earned Yen1,084.2 billion
(approx. US $11.7 billion) in annual revenues in fiscal 2009. For
more information, visit www.otsuka.co.jp/en
About GW
GW was founded in 1998 and listed on the AIM, a market of the
London Stock Exchange, in June 2001. Operating under license from
the UK Home Office, the company researches and develops cannabinoid
pharmaceutical products for patients who suffer from a range of
serious ailments, in particular multiple sclerosis and cancer pain.
GW has assembled a large in-house scientific team with expertise in
cannabinoid science as well as experience in the development of
both plant-based prescription pharmaceutical products and medicines
containing controlled substances. GW occupies a world leading
position in cannabinoids and has developed an extensive
international network of the most prominent scientists in the
field. For further information, please visit www.gwpharm.com
This news release may contain forward-looking statements that
reflect GWs current expectations regarding future events, including
development and regulatory clearance of the GW's products.
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) and other products by consumer and medical
professionals.
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCLLFSALTLFFII
Gw Pharmaceuticals (LSE:GWP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Gw Pharmaceuticals (LSE:GWP)
Historical Stock Chart
From Jul 2023 to Jul 2024