GW Pharmaceuticals plc (GWP:AIM) announces that it has completed patient recruitment into its Sativex® Phase III MS Spasticity trial. This trial was requested by the UK regulator prior to obtaining approval for Sativex in this indication. The trial is due to report results in Q1 09 and a regulatory submission is planned shortly thereafter.
In total, 575 patients have been recruited into this study, by far the largest study GW has ever undertaken. Recruitment was achieved in just ten months using 52 hospital sites in five countries – UK, Spain, Italy, Czech Republic and Poland.
In December 2007, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), published a Public Information Report on Sativex which provided specific guidance on the route to approval in the indication of MS spasticity. The key outstanding requirement was to perform an additional Phase III clinical trial, the design of which was specified by the UK regulator and formally agreed in writing with GW.
The Phase III trial follows an “enriched design” which first identifies responders over a four week period (Phase A), and then focuses on analysing the effect of Sativex vs placebo on those responders over a further period of 12 weeks (Phase B). The study has enrolled 575 patients into Phase A and it is expected that approximately 255 patients will enter Phase B. This will exceed the original target number of 244 Phase B patients. The primary endpoint of the study is the difference in the severity of spasticity as assessed on the validated Numeric Rating Scale between the Sativex and placebo groups in Phase B of the study.
GW recently reported positive results from a placebo-controlled “randomized withdrawal” study of Sativex in patients with MS neuropathic pain, the design of which bears important similarities to the Phase III MS spasticity study. If the difference between Sativex and placebo achieved in the MS pain trial are replicated in the Phase III MS spasticity study, this Phase III study will meet its objectives.
Dr Stephen Wright, R&D Director, said, “This is the largest study that GW has undertaken and I am delighted that our clinical operations team has completed patient recruitment in such a rapid time frame. We look forward to reporting the results of this study and to submitting a regulatory application next year.”
Notes to Editors
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 pain and other neurological symptoms. GW has assembled a team of over 100 scientists with extensive experience in developing 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.