GWP.L Regulatory News (GWP)

19 Jan 2005 07:00

GW Pharmaceuticals PLC19 January 2005 Embargoed until 0700 19 January 2005 GW Pharmaceuticals plc ("GW" or "the Company") GW Announces Positive Preliminary Results with its Cannabis-based Medicine (Sativex(R)) in Phase III Cancer Pain Trial GW Pharmaceuticals announces positive preliminary results in a Phase IIIclinical trial with Sativex(R) in 177 patients with severe cancer pain. The trial was a multi centre double-blind, randomised, placebo-controlledparallel group study. Patients in the study had advanced cancer and wereexperiencing pain that was not responding adequately to strong opioid medication(e.g. morphine). In addition to study medication, all patients remained on theirexisting opioid and other analgesic medication during the trial. The study included two different study medications - Sativex (a cannabismedicine containing tetrahydrocannabinol (THC) and cannabidiol (CBD)) and aTHC-rich extract. Patients entering this three arm study were randomised equallyto one of Sativex, THC extract or placebo. Each of these study medications wereadministered by means of a spray into the mouth. In this Phase III trial, Sativex achieved a statistically significantimprovement in comparison to placebo in pain as measured on a numerical ratingscale (p=0.014), a primary endpoint of the study. A responder analysis showedthat approximately 40% of patients on Sativex showed a greater than 30%improvement in their pain (p=0.024). Analysis of escape medication, a second primary endpoint, showed that there wereno significant changes in the use of escape medication. The improvements seen inpain were therefore attributable to the positive effects of Sativex. The other active arm of this study, GW's THC extract did not show a significanteffect in pain (p=0.24). This trial therefore suggests that Sativex is the moreeffective product for use in cancer pain. In the trial, the adverse event data showed the medicines to be generally welltolerated. Approximately 40 per cent of cancer sufferers at present have unmet needs inpain suppression. Dr Stephen Wright, GW's R&D Director, said, "Patients in this trial weresuffering intense pain as a result of their cancer despite using currentlyavailable strong opioid treatments and therefore have a very high clinical need.The data from this important trial further demonstrates the broad potential ofSativex, not only in its initial Multiple Sclerosis and neuropathic painmarkets, but also in cancer and potentially other types of chronic pain. Thesepositive results suggest that Sativex may represent a valuable new treatmentoption for this group of patients. "We will now be actively reviewing the next steps, including a possible furtherPhase III confirmatory clinical trial, towards securing regulatory approvals forthe use of Sativex in cancer pain." Sativex is currently the subject of regulatory applications in both the UK andCanada. A Qualifying Notice for approval in Canada was received in December 2004for the use of Sativex in the treatment of neuropathic pain in MultipleSclerosis. In both countries, upon approval, Sativex will be exclusivelymarketed by Bayer HealthCare. - Ends - Enquiries: GW Pharmaceuticals plc Today: 020 7067 0700Dr Geoffrey Guy, Chairman Thereafter: 01980 557000Justin Gover, Managing DirectorDr Stephen Wright, R&D DirectorMark Rogerson, Press and PR 07885 638810 Weber Shandwick Square Mile 020 7067 0700Kevin Smith / Sarah MacLeod This news release may contain forward-looking statements that reflect theCompany's current expectations regarding future events, including the clinicaldevelopment and regulatory clearance of the Company's products. Forward-lookingstatements involve risks and uncertainties. Actual events could differmaterially from those projected herein and depend on a number of factors,including (inter alia), the success of the Company's research strategies, theapplicability of the discoveries made therein, the successful and timelycompletion of clinical studies, including with respect to Sativex and theCompany's other products, the uncertainties related to the regulatory process,and the acceptance of Sativex and other products by consumers and medicalprofessionals. This information is provided by RNS The company news service from the London Stock Exchange