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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
GW Pharm. | LSE:GWP | London | Ordinary Share | GB0030544687 | ORD 0.1P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 735.00 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
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0 | 0 | N/A | 0 |
RNS Number:9665Z GW Pharmaceuticals PLC 17 March 2006 GW PHARMACEUTICALS PLC ("GW" or "the Company") PRELIMINARY RESULTS FROM SATIVEX(R) PHASE III MULTIPLE SCLEROSIS SPASTICITY STUDY GW to evaluate optimal regulatory filing strategy with marketing partners Porton Down, UK, 17 March 2006 - GW Pharmaceuticals plc (AIM: GWP) today announces preliminary results from a Phase III study of Sativex(R) in the relief of spasticity in people with Multiple Sclerosis (MS). This study is one of a number of Phase III studies which are currently taking place to support approval of Sativex across Europe in a range of target indications. Analysis of the per protocol population (those patients that complied with the study protocol) showed a positive and statistically significant improvement in the primary outcome measure (p0.05). Dr Stephen Wright, R&D Director at GW, said: "The study supports the significant positive data already generated from previous GW studies in people with MS who have failed to respond to currently available anti-spasticity treatments. This is a high need patient population and we are considering the regulatory impact of this new study in light of the different outcomes of the two statistical analyses and in the context of our overall regulatory strategy for Sativex. Whilst this study may provide GW with a regulatory route in Europe for the spasticity indication, the bulk of our positive clinical data relates to neuropathic pain. We have two further Phase III neuropathic pain studies due to report later this year and we need to consider with our marketing partners the relative benefits of awaiting that data before submitting the next regulatory filing." The trial reported today was a randomized placebo-controlled parallel group study in 335 people with spasticity due to MS. All patients entering the study were taking best available anti-spasticity medication and remained on such medication through the trial. Hence, any improvements seen in the trial were obtained over and above currently available treatment. The primary outcome measure was the improvement in spasticity as measured on a 0-10 numeric rating scale. The duration of treatment in the study was 14 weeks. In this trial, the primary endpoint, and two key secondary endpoints (the Responder Analysis and the Carer Global Impression of Change), in the per protocol analysis achieved statistical significance, whereas the outcomes in the ITT analysis were positive but non-significant. The lack of significance in the ITT analysis was not due to a lack of effect of Sativex, but rather was due to a larger than expected placebo response, thus reducing the size of the difference between the two groups. Had the placebo response been the same as in GW's previous completed Phase III spasticity study, the ITT analysis in this new study would also have been statistically significant. Separately, a pooled analysis across the three Sativex MS spasticity studies now completed, incorporating a total of 652 patients, shows Sativex to be significantly superior to placebo (p
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