27th Oct 2015 11:32
LONDON (Alliance News) - GW Pharmaceuticals PLC Tuesday said the remaining two Phase 3 trials for its Sativex product were consistent with the first trial in that Sativex did not meet the primary endpoint, although they did show a "statistically significant improvement" for Sativex compared with a placebo.
Sativex is being investigated for the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy.
"In light of the missed primary endpoint in the first trial earlier this year, these additional results are not a surprise. Nevertheless, we are encouraged by data across the trials which consistently show positive outcomes for US patients when analysed as a separate cohort," said GW Chief Executive Justin Gover.
"We believe that this finding may provide important guidance in determining the optimal target patient population for Sativex and look forward to a discussion with the FDA on a potential path forward," Gover added.
"While the results overall have been disappointing, and not necessarily wholly consistent with clinical experience, nonetheless they suggest that Sativex may have a useful role in the treatment of certain subgroups of patients with advanced cancer pain who have exhausted opioid treatments," said Marie Fallon, professor of Palliative Care, University of Edinburgh and a principal investigator in the Phase 3 programme.
In a separate statement, GW Pharmaceuticals said it has signed a memorandum of understanding with the government of New South Wales in Australia to progress a research programme for its Epidiolex product and the chemical compound cannabidivarin in children with severe, drug resistant childhood epilepsy.
Epidiolex is a cannabidiol, which, like cannabidivarin, is a chemical compound identified in cannabis.
"GW is pleased to have been able to respond to the needs of the New South Wales government and its citizens by establishing this research programme for cannabinoid-based medicines in children with treatment-resistant epilepsy," Gover said.
"As part of this research partnership, GW expects to advance clinical trials in Australia for both Epidiolex and our earlier stage pipeline product CBDV," he added.
Neither Epidiolex or cannabidivarin produce the psychoactive effects associated with herbal cannabis, GW said.
Shares in GW were trading down 1.9% at 421.50 pence Tuesday morning.
By Karolina Kaminska; [email protected] @KarolinaAllNews
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