GW Pharma's cannabis drug fails in cancer pain study (updated)
08/01/2015 15:58
* Sativex misses goal in first Phase III cancer pain study
* Two further studies to report results later this year
* GW shares bounce back after falling as much as 21 pct
(Updates with share price recovery)
By Ben Hirschler
LONDON, Jan 8 (Reuters) - An experimental cannabis drug
failed to alleviate pain in cancer patients as hoped in a
clinical study, sending shares in its British maker GW
Pharmaceuticals GWP.L sharply lower initially before they
bounced back.
GW, which is developing the drug Sativex for pain in
collaboration with Japan's Otsuka 4768.T , said the first of
three late-stage trials found no statistically significant
difference between subjects using its product and those given a
placebo.
GW Chief Executive Justin Gover said the findings were both
disappointing and surprising, given encouraging results in
earlier tests, but the company's scientists had not given up
hope.
Results from two further Phase III trials are due later this
year and, if positive, could still allow the drug to be
submitted for treating pain in patients with advanced cancer,
where it is designed to be given on top of opioids.
"Although we missed the primary endpoint in this trial,
based upon the positive data seen in the Phase II programme, we
remain confident in the ability for Sativex to relieve cancer
pain in this patient population," Gover said.
Shares in GW, which have been on a roll on hopes for its
so-called cannabinoid medicines since the firm listed on Nasdaq
in 2013, fell as much as 21 percent before recovering to stand 5
percent higher by 1550 GMT amid hopes the drug might yet work.
The wider biotech market also leant support, with the Nasdaq
Biotech index .NBI extending a rally from Wednesday on a spate
of good clinical data from several companies. ID:nL1N0UN123
Sativex, which is given as an under-the-tongue spray, is
already approved for treating spasticity caused by multiple
sclerosis in 27 countries, although not yet in the United
States.
In addition to trying to expand Sativex's use into pain
relief, GW is also developing other cannabis-derived drugs. One
of these, Epidiolex, has produced promising results in children
with hard-to-treat epilepsy and GW said work on this programme
was on track or ahead of schedule.
Phase III data on Epidiolex in treatment-resistant epilepsy
is now expected by the end of 2015.
Interest in the medical effects of cannabis has been spurred
recently by the legalisation of recreational marijuana shops in
Colorado and Canada's move to create a federally regulated
medical marijuana industry.
But GW, which grows cannabis under licence at a secret
location in Britain, distances itself from this by emphasising
its ability to extract key ingredients for medical use, in the
same way that painkillers have been developed from opium.
(Editing by Pravin Char and Susan Thomas)
((ben.hirschler@thomsonreuters.com; +44 20 7542 5082; Reuters
Messaging: ben.hirschler.thomsonreuters.com@reuters.net))
Keywords: GW PHARMA EPILEPSY/