Phase I trial with cannabis for medical use
A British drug company said on 16 November it hoped to have a
cannabis-based medicine ready to be prescribed by doctors within
three or four years. GW Pharmaceuticals said it was making
progress in clinical studies with cannabis-based medicines.
Volunteers had been taking cannabis under clinical conditions in
order to determine the best dose and toleration of treatment. The
pilot Phase I study involved just six healthy individuals and was
intended to pave the way for larger patient trials. They had taken
cannabis either from an inhaler or via liquid under the tongue.
Dr Geoffrey Guy, the company's chairman, said: "All the subjects
came through very well, and we were very pleased with the
study. Now we have a much better idea of what our starting point
should be." Heart rate, temperature and respiration were
monitored and blood samples taken for analysis. In addition each
volunteer went through a battery of cognitive and psychometric
tests. Dr Guy said: "We have been able to define and follow
through the psychoactive effects. None of the effects is
disturbing, or would be classed in a clinical trial as serious." He
said patients did not need to "get high" to gain a therapeutic
benefit.
If approved by the regulatory authorities, the second phase trials
would commence next year. They will involve up to two or three
hundred patients with multiple sclerosis, spinal cord injury, and
phantom limb pain, said Dr Guy. By the end of the final Phase III
trials a total of around 2,000 patients will have taken part. The
main studies should be completed in 2002.
"Subject to the necessary regulatory approvals, we hope to have a
cannabis-based medicine available for prescription by doctors
within three to four years," Guy said. GW Pharmaceuticals is
licensed by the British Home Office (Interior Ministry) to grow,
possess and supply cannabis for medical research. Dr Guy
personally potted GW Pharmaceuticals' 20,000th cannabis plant
on August 24 this year. The plants are housed in a highly secure
and environmentally controlled glasshouse at a secret location.
(Sources: Reuters of 16 November 1999)