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Trials Show Cannabis Spray Helps MS Patients

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Source: Guardian Unlimited


Shares in GW Pharmaceuticals, the company pioneering research into cannabis-based medicines, soared 17.5% to 151p yesterday as it prepared to announce positive trial results this morning.


The Salisbury-based business will say tests on treatments for patients with multiple scelorosis (MS) have been successful and it plans to apply for early approval to make products available to patients.


GW has been developing for three years a range of products based on cannabis extracts that can be taken orally via a spray under the tongue.


The latest results are the first from seven, phase three, clinical trials being undertaken on 600 patients but they pave the way for the development of what could become a £250m per annum market.


GW is the only holder of the only UK licence to develop cannabis-based medicines and has been pouring cash into research. This summer it reported a £5.3m loss for the six months to March 31 and now hopes to launch its first cannabis-based drug in early 2004.


There are currently no prescription drugs based on cannabis but any go-ahead from the medicines control agency is likely to have wider social implications.


Hundreds of MS sufferers are believed to be using cannabis illegally amid widespread anecdotal evidence that it relieves pain associated with the condition.


GW Pharmaceuticals declined to comment on heightened speculation about its latest clinical trials. "All I can say is we will be announcing the preliminary phase three results tomorrow as we had previously indicated," said a spokesman.


The company has had to increase the amount of cannabis it grows in Britain to cater for its trials. GW is also undertaking tests on relieving cancer pain and the National Institute for Clinical Excellence is examining whether there are opportunities for future drugs of this kind to be used inside the health service.

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GW Pharmaceuticals has published preliminary results of four phase three tests, the last stage of drug evaluation before approval, showing the medicine helped relieved symptoms of multiple sclerosis.


Its product, which is sprayed into the mouth rather than smoked, was significantly better than a placebo in reducing nerve damage pain, spasticity and sleep disturbance in the tests involving around 350 patients.


GW - which cultivates some 40,000 cannabis plants a year at a secret location in the English countryside - now plans to seek marketing approval from Britain's Medicines Control Agency early next year.


"The performance of GW's medicine has exceeded our own expectations," executive chairman Geoffrey Guy said.


"Subject to regulatory approval, we are now on track to deliver our first prescription medicine to the UK market next year."


Julie Simmonds, biotechnology analyst at Evolution Beeson Gregory, expects GW's cannabis spray to generate peak sales of around 250 million pounds ($US388.9 million) a year in Europe and Canada, the first markets where approval will be sought.


The British Government has already indicated it is ready to alter the medical schedule of drugs that doctors are allowed to prescribe.


Europe and Canada are expected to follow any green light from Britain within six to nine months, although approval in the United States will be at least two years behind.


GW, which reported a loss of 5.3 million pounds in the six months to March 31, has been holding talks with a number of pharmaceutical firms interested in licensing its cannabis medicines.


But the company, which has enough cash to last it through to 2004, is in no rush to strike a deal.


"They may well wait to sign a collaboration until next year when they've got the complete phase III data and the product has gone into registration, because they could get a better deal then," Ms Simmonds said.


A further five phase three trials are in progress as part of an overall program which is the largest ever undertaken into the medicinal effects of cannabis.

Source:ABC On-line

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