Co-operative Research projects for SMEs - European Commission ...

Cannabis: extracting medical
benefits for the future
“Cannabis is more accepted as a
Medicines derived from cannabis have been
potential medicine than it was a few
used throughout Europe and Asia since ancient times.
years ago.”
With the advent of modern medicine, the drug’s ability to ease
pain and inflammation has been put rigorously to the test, with
variable results. One of the problems is that as there is no procedure for
producing standardised extracts of cannabis, the chemical composition of such
extracts varies. The partners in the Co-operative Research project Cannabis aim to devise a
procedure for standardising extracts. This, they hope, will generate preparations suitable for use in
large-scale clinical trials and, ultimately, will help in the treatment of arthritis and migraine.
Cannabis has an image problem. Thanks to its psychoactive properties,
it continues to be regarded in large swathes of the developed
world first as a drug of abuse, and only second as a potential medicine.
Yet indications that it can relieve pain associated with even
the most debilitating of diseases are intriguing. The goal of the
Cannabis project is to raise the drug’s status as a medicine by producing
a procedure for extracting its painkilling constituents in a
standardised way.
This project represents an entirely novel approach to the development
of cannabis-based medicines. Until now, researchers have tended
to home in on particular cultivars or strains of the plant, Cannabis
sativa, from which they extract therapeutically promising compounds.
But because they claim intellectual property rights on the
cultivar rather than on the end product or the procedure by which
it is derived, the chemical composition of that end product may vary.
It can be affected by numerous factors, even the time of year
when the plant is harvested.
This is not a new problem in the medicinal application of cannabis.
Once widely prescribed as a herbal remedy, its unpredictable
potency led to it being removed from the US Pharmacopeia and
National Formulary in 1941, and the British National Formulary
in 1971. Michael Heinrich, project coordinator of Cannabis, thinks
it may also be a reason why the results of more recent clinical
trials have been mixed.
The people’s choice
In 2003, the medical journal The Lancet reported equivocal results
in a trial of one orally delivered cannabis-based product in 630 multiple
sclerosis patients. While the product seemed to have no effect
in relieving muscle spasm, as measured by a formal scoring system
of muscle stiffness, the patients themselves felt that it helped them.
There have been no controlled studies of the effects of cannabis
preparations in arthritis and migraine patients, but surveys suggest
that large numbers of people suffering from these conditions continue
to risk prosecution and the dangers of obtaining their cannabis
from street dealers, to self-medicate with the drug.
Indeed, it was the appearance of a number of MS patients in British
courts in the mid- to late 1990s that encouraged the UK government
to cautiously consider legalising medicinal cannabis, as long as a
pharmaceutical form of it could be found. Different countries take
different positions on the issue, says Heinrich, and some are less
open-minded. But in general, people are warming to the idea that
complex plant-based preparations could have advantages over simpler,
synthetic drugs when it comes to treating pain. And they are
beginning to see cannabis as something more than a recreational
drug.
Bottom-up approach
The partners in the Cannabis project hope to take advantage of this
shift in attitudes. They want to eliminate the problem of variable potency
by devising a procedure for producing standardised cannabis
extracts which can be delivered orally and are suitable for clinical
use. Preferably, these extracts should also be low in tetrahydrocannabinol
(THC), the drug’s psychoactive component. The team
will then claim the procedure, rather than the starting material, as
its intellectual property. This is a recognised approach to IP that has
been applied, for instance, to the production of extracts of St
John’s Wort and Ginkgo biloba, now widely sold as herbal
remedies.
And the group is well equipped to succeed, Heinrich says. The three
SMEs (small and medium-sized enterprises) involved bring expertise
in phytopharmaceuticals or plant-based drugs, biochemistry and
animal models of human neurological
disease. But
because they lack the
in-house research
capacity to perfect
the extraction
procedure
Female
Cannabis
sativa plant from
which the resin is
derived for pharmacological
testing.
© University of London
School of Pharmacy
CANNABIS