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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.
GW Pharmaceuticals reports progress
on clinical studies with cannabis-based medicines
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.
tolerability, the blood level and cognitive data will
be collated shortly, and should enable GW to establish
the safe envelope of usage.
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.
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.
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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