GWP.L Regulatory News (GWP)

25 Nov 2009 07:02



Sativex® Phase II/III Cancer Pain Study Completes Patient Recruitment

Porton Down, UK, 25 November 2009: GW Pharmaceuticals plc (GWP:AIM) announces that it has completed recruitment into its Sativex® Phase II/III cancer pain trial. This study is being carried out in collaboration with Otsuka Pharmaceutical Co. Ltd, GW's US licensing partner, as part of the US development programme for Sativex. The trial is due to report results in Spring 2010. 

In total, 360 patients have been recruited into this study across 14 countries in North America, Europe, Latin America and South Africa. Patients enrolled in this study have advanced cancer for which there is no known curative therapy and have a clinical diagnosis of cancer-related pain, which is not wholly alleviated with their current strong opioid treatment. This patient group represents as many of 30% of people who suffer pain from late stage cancer.

The primary objective of the study is to evaluate the optimum dose range of Sativex in these patients as an adjunct to their pre-existing pain medications. The primary endpoint of the study is the response rate for patients at the end of 5 weeks of therapy, as defined by a 30% or greater reduction in the 0-10, Numeric Rating Scale (NRS).

This study is the first major trial carried out in collaboration with Otsuka as part of the development programme aimed at securing regulatory approval for Sativex from the Food & Drug Administration (FDA), the US regulatory authority. The current US development programme anticipates two further Phase III trials prior to a subsequent submission of a New Drug Application to the FDA. GW and Otsuka have already commenced preparation for these two trials with an aim to starting as soon as possible following receipt of the Phase IIb/III trial data, and further discussions with FDA.

Dr Stephen Wright, R&D Director, said, "GW and Otsuka enjoy an excellent working relationship and the successful completion of recruitment into this study represents an outstanding effort from the clinical operations teams of both companies. We look forward to reporting the results of this study next year."

Dr. Nathaniel Katz, former Chair of the FDA Pain Advisory Committee and Adjunct Assistant Professor of Anesthesia, Tufts University School of Medicine, said, "GW and Otsuka deserve congratulations for successfully recruiting this number of patients in such a challenging clinical trials area. This study is one of the largest ever conducted in this patient population and we look forward to the results with great interest and excitement."

The Sativex cancer pain clinical programme is being funded by Otsuka under the terms of the US license agreement with GW. Data from these trials will also be available to GW for submission to regulatory authorities in Europe and elsewhere. 

Enquiries:

Notes to Editors

About Sativex

Sativex is an investigational new product composed primarily of two cannabinoids: CBD (cannabidiol,) and THC (delta 9 tetrahydrocannabinol). Sativex is administered as a metered dose oro-mucosal spray, each 100µL spray contains 2.7mg THC and 2.5mg CBD. The Sativex formulation is standardized by both composition and dose and is supplied in small spray vials. The components of Sativex have been shown to bind to cannabinoid receptors that are distributed throughout the central nervous system and in immune cells.

Sativex in Cancer Pain

Sativex has previously been the subject of a clinical trial in 177 patients conducted in Europe. In this study, Sativex was administered to patients with terminal cancer and persistent pain that was not fully relieved by current strong opioid therapy. The primary endpoint of this study was the change from baseline to endpoint in the NRS pain score. Sativex, as adjunctive treatment to strong opioid therapy, was associated with a larger decrease in NRS score than was placebo and strong opioids (p=0.014). In addition, 43% of patients who received Sativex, while remaining on opioids, exhibited at least a 30% decrease in their pain score compared to 21% of patients receiving placebo and opioids (p= 0.006)

Treatment related adverse events in this study were reported by 85% of patients receiving Sativex and by 75% of patients receiving placebo. The most common adverse events (> 10%) reported by patients in this study were somnolence (15% Sativex® vs. 13% placebo); nausea (12% Sativex® vs. 11% placebo) and dizziness (12% Sativex® vs. 5% placebo). Serious adverse events reported by more than one patient receiving Sativex were urinary retention (n=2) and progression of the underlying cancer (n=6).

In 2007, GW obtained approval for Sativex in Canada in the indication of cancer pain under Health Canada's Notice of Compliance with conditions (NOC/c) policy.

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 the 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 153 companies and employs approximately 36,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥955.9 billion (approx. US $9.7 billion*) in annual revenues in fiscal 2008. 

* Exchange rate as of March 31, 2009.

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 more information, 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® and other products by consumer and medical professionals.