GWP.L Regulatory News (GWP)

9 Nov 2005 07:01

GW Pharmaceuticals PLC09 November 2005 For immediate release 9 November 2005 GW Pharmaceuticals plc ("GW" or "the Company") Rheumatology Journal Publishes Positive Sativex(R) Study in Rheumatoid Arthritis Rheumatology, the official monthly journal of the British Society of Rheumatology (BSR), today announces the publication of the first study to use a cannabis-based medicine (CBM) for treating rheumatoid arthritis. The CBM used in the study is Sativex(R) oromucosal spray which is standardised for composition, formulation and dose and was developed by GW. The full statement released today, follows below: Embargoed: 00.01 hrs London time, Wednesday 9 November 2005 Cannabis-based medicine relieves the pain of rheumatoid arthritis and suppresses the disease The first study to use a cannabis-based medicine (CBM) for treating rheumatoidarthritis has found that it has a significant effect on easing pain and onsuppressing the disease. Writing in the medical journal Rheumatology (1), the researchers say thatalthough the differences were small and variable in the group of 56 patientsthey studied, the results are statistically significant and a larger trial isneeded to investigate in more detail the effects of CBM on the disease whichaffects approximately 600,000 people in the UK (1 in 100 of the population).(2) There is anecdotal evidence that cannabis can provide pain relief for peoplewith rheumatoid arthritis (RA), and in a recent survey 155 (16%) of 947 peoplewho obtained cannabis on the black market for medicinal reasons said they did soto obtain relief from symptoms of RA. However, this study in Rheumatologyjournal, led by David Blake, Professor of Bone and Joint Medicine at the RoyalNational Hospital for Rheumatic Diseases (RNHRD), Bath, and the University ofBath, UK, is the first randomised controlled trial to investigate the effect ofa CBM on RA. It is published online today (Wednesday 9 November). In the double-blind trial, the researchers randomised 31 patients to receive theCBM and 27 the placebo. The CBM (brand name: Sativex) was in the form of aneasy-to-use mouth spray that patients could administer themselves up to amaximum of six doses a day. The CBM consisted of a blend of whole plantextracts, standardised for content, that delivered approximately equal amountsof two key therapeutic constituents from the cannabis plant:delta-9-Tetrahydrocannabinol (THC) and cannabidiol (CBD). Mouse studies have shownthat THC and CBD have anti-inflammatory effects, and that CBD blockedprogression of RA and produced improvements in symptoms. Dr Ronald Jubb, Consultant Rheumatologist, at the University Hospital BirminghamNHS Foundation Trust, UK, said: "Patients had a baseline assessment at thebeginning of the trial and then were randomised to receive either the CBM orplacebo. Patients only took the doses in the evening in order to minimisepossible intoxication-type reactions. The starting dose was one actuation withinhalf an hour of retiring, and this was increased by one actuation every two daysto a maximum of six doses according to individual response over a period of twoweeks. Stable dosing was then maintained for a further three weeks." The researchers found that in comparison with the placebo, patients who hadtaken the CBM had statistically significant improvements in pain on movement,pain at rest, quality of sleep, inflammation (measured by a Disease ActivityScore involving 28 joints - DAS 28) and intensity of pain (measured by theShort-Form McGill Pain Questionnaire SF-MPQ). For instance, on a score of 0-10 where 0 is no pain, CBM patients on averagemoved from 7 to 4.8 for pain on movement (placebo patients moved from 6.7 to5.3), 5.3 to 3.1 (placebo 5.3 to 4.1) for pain at rest, and 5.7 to 3.4 (placebo5.8 to 4.6) for quality of sleep. On the DAS 28 score of 0-10, the CBM patientsmoved from 5.9 to 5 (placebo 6 to 5.9), and on the SF-MPQ score of 0-100 forintensity of pain at present, the CBM patients moved from 48 to 33, while theplacebo patients remained unchanged at 50. Adverse side effects were mostly mild or moderate (e.g. dizziness,light-headedness, dry mouth, nausea). Of the eight patients who experienced milddizziness, in four patients this occurred during the initial two-week periodwhen they were gradually increasing the doses, and two occurred two days afterthis initial period, so these were probably due to patients getting used to thecorrect dose. No patients taking the CBM had to withdraw from the trial due toadverse side effects, but three did from the placebo group. Dr Philip Robson, Senior Research Fellow and Consultant Psychiatrist at theOxford University Department of Psychiatry and Director of the CannabinoidResearch Institute within GW Pharmaceuticals (the manufacturer of Sativex),explained: "Withdrawals from the placebo group were probably due to apsychological effect, a spontaneous occurrence, or a reaction with anothermedicine." Dr Jubb said: "The results from the first controlled study of CBM in rheumatoidarthritis are encouraging, with overall improvements in pain on movement and atrest, improvement in the quality of sleep and improvement in the overallcondition of the patients' arthritis. Whilst the differences are small andvariable across the patient group, they represent benefits of clinical relevanceand indicate the need for more detailed investigation through larger trials tosee exactly where CBM could be best used with minimum side effects." If further trials are run, researchers will probably extend the dosing periodover the full 24-hour period. Dr Robson said: "The beneficial effects in thisstudy occurred in the context of a dosing regime restricted to evening dosing inorder to minimise any possible intoxication-type reactions. However, 24-hourdosing with Sativex, using a self-titration regime, in trials for multiplesclerosis resulted in only minimal intoxication scores." He continued: "The element that can cause the 'high' in cannabis - THC - alsohas valuable pharmacological activity. It is thought to be an essentialtherapeutic component and therefore it can't be removed from the medicine.However, the method of giving the doses, via the mouth spray, and the principleof self-titration, where each patient gradually determined their own optimaldose level up to a maximum of six doses a day, minimised the risk ofintoxication." Dr Robson said that fears that the CBM could be abused by patients hoping to geta "high" were probably unfounded. "It seems that in practice this is a very rareevent. More than 1,000-patient years of treatment with Sativex in clinicaltrials have been accumulated and to date there has not been a single documentedcase of abuse. The fact is that the motivation of medicinal users ofcannabis-based medicine is entirely different from recreational users: theformer simply want symptom relief and the ability to go about their normallives, and for them intoxication would be a distinct disadvantage; for thelatter, smoking marijuana is infinitely more intoxicating than Sativex and isstill easily available." (ends) (1) Preliminary assessment of the efficacy, tolerability and safety of acannabis-based medicine (Sativex) in the treatment of pain caused by rheumatoidarthritis. Rheumatology Advance Access published on November 9, 2005. doi:10.1093/rheumatology/kei183 (2) Rheumatoid arthritis affects three times as many women as men. Prevalence inthe UK is approximately 0.5% in men and 1.8% in women, increasing after the ageof 64 to 2% in men and 5% in women. There are many more people with less severeforms of RA that do not meet the diagnostic criteria for definite or classicaldisease. Notes:1. PDF version of this press release and full embargoed text of the paper can befound from 12.00 hrs London time on Monday 7 November 2005 at: http://www.oxfordjournals.org/brheum/press_releases/nov05.pdfThe pdf is also available from Emma Mason. 2. The paper will be published online on Wednesday 9 November 2005 at: http://rheumatology.oxfordjournals.org/cgi/reprint/kei183v1The Rheumatology journal website is: www.rheumatology.oxfordjournals.orgPlease acknowledge Rheumatology as a source 3. Rheumatology is the official monthly journal of the British Society forRheumatology (BSR). The BSR website is: http://www.rheumatology.org.uk/ Contact (media enquiries only):Emma MasonTel: +44 (0)1376 563090 Mobile: +44 (0)7711 296 986Email: wordmason@mac.com - Ends -Enquiries: GW Pharmaceuticals plc Today: (44) 20 7067 0700Dr Geoffrey Guy, Chairman Thereafter:(44) 1980 557000Justin Gover, Managing DirectorDr Philip Robson, Cannabinoid Research InstituteMark Rogerson, Press and PR (44) 7885 638810 Weber Shandwick Square Mile (44) 20 7067 0700Kevin Smith/Yvonne Alexander About GW Pharmaceuticals plc GW Pharmaceuticals plc is licensed by the UK Home Office to undertake apharmaceutical research and development program to develop non-smokedcannabis-based prescription medicines. GW's shares are publicly traded on AiM, amarket on the London Stock Exchange. Full details of GW and the company's clinical trials program can be found atwww.gwpharm.com. GW's clinical research program is being carried out by a teamof pharmaceutical professionals experienced in drug development and, inparticular, the development of plant-based medicines and drug delivery systems. This news release may contain forward-looking statements that reflect GW'scurrent expectations regarding future events, including the clinical developmentand regulatory clearance of its products. Forward-looking statements involverisks and uncertainties. Actual events could differ materially from thoseprojected herein and depend on a number of factors, including (inter alia), thesuccess of GW's research strategies, the applicability of the discoveries madetherein, the successful and timely completion of clinical studies, includingwith respect to Sativex and GW's other products, the uncertainties related tothe regulatory process, and the acceptance of Sativex and other products byconsumers and medical professionals. 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