5th
November 2002
GW
Announces Positive Results From Each of Four Phase
Three Clinical Trials
GW
Pharmaceuticals plc, the company developing a portfolio
of non-smoked cannabis-based prescription medicines,
is today announcing preliminary results from its first
four completed Phase III clinical trials.
The
key points of the results can be summarised as follows:
€€€
* GW"s four randomised, double-blind, placebo-controlled
Phase III trials included approximately 350 patients
suffering from Multiple Sclerosis and neuropathic
pain
€€€
* Each of the four trials reported positive data,
including statistically significant reductions in
neuropathic pain, spasticity and sleep disturbance
€€€
* As a result of these positive results, GW now intends
to submit its first regulatory application to the
Medicines Control Agency early next year
€€€
* Subject to regulatory approval, the UK market launch
of GW"s first cannabis-based medicine could now
be in 2003
Dr
Geoffrey Guy, Executive Chairman of GW, said: "These
preliminary Phase III results represent a major milestone
in the pharmaceutical development of cannabis-based
medicines. The performance of GW"s medicine has
exceeded our own expectations and holds out the prospect
of providing a significant advance in the treatment
of these most challenging of medical conditions. Subject
to regulatory approval, we are now on track to deliver
our first prescription medicine to the UK market next
year.’
Enquiries:
GW
Pharmaceuticals plc
Dr
Geoffrey Guy, Executive Chairman
Justin
Gover, Managing Director
Mark
Rogerson, Press and PR (05/11/02) 020 7950 2800
(Thereafter)
01980 557000
07885
638810
Weber
Shandwick Square Mile
Kevin
Smith/Graham Herring 020 7950 2800
€
GW
Announces Positive Results From Each of Four Phase
Three Clinical Trials
GW
Pharmaceuticals plc, the company developing a portfolio
of non-smoked cannabis-based prescription medicines,
announces positive preliminary results from each of
four completed Phase III clinical trials in patients
suffering from Multiple Sclerosis and neuropathic
pain. As a result of these positive results, GW now
intends to submit its first regulatory application
to the Medicines Control Agency early next year. Subject
to regulatory approval, the UK market launch of GW"s
first cannabis-based medicine could be achieved during
2003.
GW"s
four randomised, double-blind Phase III trials included
approximately 350 patients and are part of the largest
clinical programme ever undertaken into the medicinal
effects of cannabis. The trials examined, in comparison
to placebo, the effectiveness of GW"s whole plant
medicinal cannabis extract containing tetrahydrocannabinol
(THC) and cannabidiol (CBD) as its principal components.
The THC:CBD medicine was administered by means of
a spray into the mouth.
In
the trials, the THC:CBD medicine achieved statistically
significant reductions in neuropathic (nerve-damage)
pain, as well as statistically significant improvements
in other symptoms of Multiple Sclerosis ("MS’),
most notably spasticity and sleep disturbance. These
findings are consistent with results from Phase II
trials previously announced by the Company.
The
four trials examined the efficacy of the THC:CBD product
in relieving symptoms in the following conditions:
€€€
* Neuropathic pain in MS
€€€
* Pain and sleep disturbance in MS and other neurological
conditions
€€€
* Multi-symptoms in MS
€€€
* Neuropathic pain in Brachial Plexus Injury
The
main summary findings from each of the studies, the
full results of which will be submitted for peer-review
publication in due course, are provided below. Results
quoted as "statistically significant" had
an associated probability value (p-value) of less
than 0.05, whilst those that are "highly statistically
significant" had a p-value less than 0.01.
In
a double-blind parallel group study comparing the
efficacy of GW"s THC:CBD product with placebo
in the treatment of neuropathic pain in 66 patients
with MS, the THC:CBD medicine provided highly statistically
significant relief of pain in comparison with placebo
and highly statistically significant reduction in
sleep disturbance.
In
a double-blind parallel group study comparing the
efficacy of GW"s THC:CBD product with placebo
in the treatment of chronic refractory pain in 70
patients with MS and other neurological conditions,
the THC:CBD medicine provided statistically significant
pain relief (as evidenced by the diminished use of
analgesic rescue medication) and statistically significant
reduction in sleep disturbance.
In
a double-blind parallel group study comparing the
efficacy of GW"s THC:CBD product with placebo
in the treatment of a number of symptoms in 160 patients
with MS, the THC:CBD medicine provided a highly statistically
significant improvement in the symptom of spasticity.
Positive trends were also observed in a number of
other MS symptoms (providing useful additional support
to significant results obtained in Phase II trials).
In
a double-blind crossover study comparing the efficacy
of GW"s THC:CBD product, GW"s THC alone
product and placebo in the treatment of neuropathic
pain in 48 patients with Brachial Plexus Injury, both
the THC:CBD medicine and the THC medicine provided
highly statistically significant relief of pain and
statistically significant reduction in sleep disturbance.
Brachial plexus injury is a rare but particularly
challenging cause of intractable neuropathic pain,
and to the best of our knowledge this is the first
placebo-controlled trial ever conducted in this condition.
The
benefits seen in all four studies are all the more
notable in that they represent improvements over and
above that which patients obtain with their standard
prescription medicines (patients receiving both active
and placebo medicines continued to take their standard
prescription medicines during the trial).
In
addition, the trials have demonstrated that GW"s
cannabis-based medicine has an excellent safety profile.
Self-titration (adjustment) of their dose enabled
most patients to achieve improvement in their symptoms
without incurring a level of unwanted effects which
would interfere with day-to-day living.
Commenting
on the trial results, Dr Philip Robson, Medical Director
of GW, said "These rigorous randomised placebo-controlled
trials indicate that GW"s cannabis-based medicine
can provide additional benefits over and above that
of standard treatments in these serious and refractory
neurological conditions. The results show statistically
significant reductions in neuropathic pain, which
is recognised as being difficult to treat and is often
particularly distressing. There were also significant
improvements in other symptoms in patients with MS,
notably spasticity and sleep disturbance. In my opinion,
it is this broad spectrum of activity, coupled with
an excellent safety profile, which gives GW"s
cannabis-based medicine the potential to make a unique
contribution towards improving the quality of life
of patients with these chronic disabling diseases.’
In
addition to the four completed trials, GW has a further
five Phase III trials in progress. These further studies
are examining other potential areas of medical benefit
for cannabis-based medicines, including pain in cancer
and spinal cord injury, and are expected to complete
during 2003. Including these further five studies,
GW"s clinical programme will have included over
1000 subjects.
GW"s
first regulatory submission will provide evidence
of efficacy generated from the positive results from
the four completed Phase III clinical trials as well
as positive results previously reported from a number
of Phase II trials. Safety data will include approximately
350 accumulated patient-years of exposure to the medicine.
Over
the past several years, the UK Government has consistently
stated that, should a prescription cannabis-based
medicine be developed which meets the rigorous standards
applied by the Medicines Control Agency, it will amend
the legislation so that such a medicine is available
for patients.
-
Ends -
Notes
on trial data:
€€€
* In the neuropathic pain trials, pain was measured
using a Box Scale 11 (BS11) pain scale. In the chronic
refractory pain trial, patients were permitted to
use escape analgesia, hence pain relief is assessed
by the frequency of use of such escape medication.
€€€
* Sleep disturbance was measured in the trials using
a BS11 scale as well as other numeric scales.
€€€
* In the MS symptoms trial, spasticity and other target
symptoms were assessed by a 100mm Visual Analogue
Scale (VAS).
http://www.gwpharm.com/news_pres_05_nov_02.html