* Epidiolex tested in 27 patients in open label U.S. study
* Reduction in seizure frequency of more than 50 percent
* Drugmaker's shares gain 15 percent to all-time high
(Adds CEO interview, more on cannabis medicines)
By Ben Hirschler
LONDON, June 17 An experimental cannabis drug
has produced promising results in a small study of children with
hard-to-treat epilepsy, sending shares in its British maker GW
Pharmaceuticals to an all-time high.
The company, which grows cannabis under licence at a secret
location in Britain, is developing a range of so-called
cannabinoid medicines. It already sells Sativex for spasticity
caused by multiple sclerosis across Europe.
The latest findings for its new product Epidiolex follow an
assessment of 27 children and young adults with
treatment-resistant epilepsy who were given the drug in two U.S.
hospitals under an expanded access programme.
Epidiolex is given as a strawberry-lime flavoured syrup
twice a day. The medicine contains the cannabinoid CBD but none
of the psychoactive ingredient THC that makes marijuana smokers
GW said on Tuesday that results after 12 weeks of therapy in
the open-label study were "encouraging", with a reduction in
seizure frequency of more than 50 percent. It now plans to start
a Phase II/III clinical trial in the second half of the year.
Justin Gover, GW's chief executive, said he expected
Epidiolex would be ready for submission to U.S. and European
regulators in 2016.
Epidiolex has been granted "orphan drug" status by the U.S.
Food and Drug Administration, which may ease its path to market
and also offers GW additional exclusivity.
The designation reflects the unmet need for new approaches
to help children with severe epilepsy syndromes such as Dravet
and Lennox-Gastaut, where seizures often persist despite high
doses of multiple anti-epileptic drugs.
Excitement over prospects for Epidiolex has been a driver
for GW's shares, which have surged since the company tapped into
a new U.S. shareholder base by listing on Nasdaq a year ago.
"It has become a central part of our valuation - there is no
doubt about that," Gover said in an interview. "That reflects a
number of reasons: the fact there is so much interest among
physicians and patients, the fact it is an orphan development
programme and the fact we own all the commercial rights
Shares in GW gained 15 percent to a record high of 430 pence
by 1400 GMT.
Interest in 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
GW, however, distances itself from these developments by
emphasising its ability to extract key ingredients in cannabis
for medical use, in the same way that pain-killing opioids have
been developed from opium.
Its established product Sativex, which is given as an
under-the-tongue spray, is currently available by prescription
for MS spasticity in 11 countries and has received regulatory
approval in an additional 13 countries.
Sativex is also in final-stage Phase III clinical
development as a potential treatment of pain in people with
(Editing by Tom Pfeiffer)