GW Pharmaceuticals reports progress on clinical studies with cannabis-based medicines

GW Pharmaceuticals, the company licensed by the UK Home Office to undertake a pharmaceutical research and development programme to develop prescription cannabis-based medicines, has commenced its clinical programme. A Phase 1 study has been carried out in healthy volunteers using a range of non-smoked pharmaceutical drug delivery technologies.

 

Dr Geoffrey Guy, Chairman of GW Pharmaceuticals, said, "These are the first studies in which human subjects have been administered fully standardised extracts of cannabis. I am pleased to report that the progress of our development programme from the laboratory to human clinical dosing has proceeded without problems. We have tested a number of non-smoked routes of delivery as well as a range of extracts with different cannabinoid ratios. The results of the study will enable us to select the optimal candidate formulations for use in our forthcoming Phase 2 patient studies, subject to approval from the MCA (Medicines Control Agency)."

In the phase 1 study, a small group of subjects have taken formulations of cannabis consisting of different ratios of cannabinoids. Mature subjects were recruited for GW's study by a specialist clinical trials unit. They have been taking the drug sub-lingually (it is absorbed directly into the blood stream via the mucosa under the tongue, rather than swallowed) and also by means of an inhaler. The study entailed measuring blood levels and conducting physiological and cognitive testing throughout.

The first tolerability, the blood level and cognitive data will be collated shortly, and should enable GW to establish the safe envelope of usage.

When the data from Phase 1 trials has been fully analysed, and subject to Medicines Control Agency approval, GW's Phase 2 trials are expected to begin in small groups of patients. Specific aspects of the patients' condition will be studied to demonstrate the effects of the drug and to establish a dose/response relationship. Having established an acceptable dose range and having shown therapeutic benefit in Phase 2, large-scale studies will be undertaken in Phase 3. Hundreds of patients may be entered into each study, which may compare active formulations with a placebo in a random order. Overall, the programme may involve some 2000 patients in the UK.

The eventual aim of the clinical development programme is to prepare data for Product Licence Approval. In the event of a Licence being granted, the Home Office has indicated it would be willing to change the Misuse of Drugs Act 1971 to allow the prescribing of a cannabis-based medicine.

Dr Guy added, "There is a considerable body of evidence to suggest that cannabis may have a number of medicinal uses, including the relief of pain and spasm in multiple sclerosis, and for pain relief in other neurological disorders, such as spinal cord injury and neuralgia. Our clinical programme will be evaluating these and other uses over the next two to three years in some 2000 patients. Subject to the necessary regulatory approvals, we hope to have a cannabis-based medicine available for prescription by doctors within three to four years."

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