GWP.L Regulatory News (GWP)

14 Sep 2009 07:00



POSITIVE SATIVEX® DATA PRESENTED AT ECTRIMS EUROPEAN MULTIPLE SCLEROSIS CONGRESS

Porton Down, UK, 14 September 2009 - GW Pharmaceuticals plc (AIM: GWP) announces that results from two clinical studies of Sativex® were presented at Europe's leading multiple sclerosis (MS) conference, the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which took place in Dusseldorf, Germany, from 9 - 12 September. The outcome of these MS spasticity studies were first reported by GW earlier this year.

Presentation of data from the Phase III MS spasticity trial was shortlisted by the conference for a prize1. In this trial, 572 patients were enrolled into Phase A and 241 continued into Phase B. The authors conclude that "Sativex demonstrated a statistically significant and clinically relevant improvement in spasticity and was well tolerated in MS patients". The primary endpoint was significantly in favour of Sativex (p=0.0002). In addition, the 30% responder analysis, spasm frequency, sleep disruption, Physician, Carer and Subject Global Impression of Change and Barthel Activities of Daily Living index were all significantly in favour of Sativex (p=0.0003, p=0.0046, p

A separate presentation from this trial specifically assessed the value of a 4-week trial of treatment of MS spasticity with Sativex2. The authors conclude that "a 4 week trial period with Sativex can effectively detect MS spasticity patients who will demonstrate positive outcomes in longer-term treatment".

Data was also presented from a randomised withdrawal trial to assess the maintenance of efficacy after long-term treatment with Sativex for spasticity in MS3. In this trial, the authors conclude that "maintenance of long-term efficacy was demonstrated with Sativex compared with placebo in this randomised-withdrawal setting". The primary endpoint, the time to treatment failure, was significantly in favour of Sativex (p=0.013). The Carer and Subject Global Impression of Change were also significantly in favour of Sativex (p=0.001 and p=0.017 respectively). 

Dr Stephen Wright, GW's R&D Director, said, "GW is leading the way in developing new treatment approaches targeted towards the relief of symptoms in people with multiple sclerosis. The studies reported at this prestigious conference show how Sativex can be personalised in a way that optimises the benefit obtained by people with otherwise treatment-resistant spasticity due to MS."

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Notes to Editors

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 

References

1.  Ambler Z, Davies P et al. A two-phase study of Sativex® in the relief of spasticity due to multiple sclerosis: Phase A single-blind response assessment followed by Phase B double-blind, randomised, placebo-controlled, parallel-group study. Poster 844 presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

2.  Montalbán X, Wright S. Trial period for new symptomatic treatments: Lessons learnt from a Sativex in MS spasticity clinical trial. Oral session 131 presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

3.  Notcutt W, Davies P et al. Results of a randomised withdrawal study of subjects with spasticity due to multiple sclerosis who were receiving long term Sativex®. Poster 845 presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)