LONDON (Alliance News) - GW Pharmaceuticals PLC said Tuesday that it has begun a second phase III clinical trial of epidiolex for the treatment of a rare treatment-resistant form of childhood epilepsy called Dravet syndrome.
GW initiated the first phase III trial of epidiolex in Dravet syndrome at the end of last month. It expects to complete patient recruitment into the second trial in 2015, with top-line results expected in early 2016.
"The start of our second pivotal Phase 3 clinical trial for epidiolex in the treatment of Dravet syndrome marks another key milestone in our plan to submit a New Drug Application for epidiolex to the (US Food and Drug Administration) in mid-2016," said Chief Executive Officer Justin Gover in a statement.
It also expects to begin two phase III trials in another form of childhood epilepsy, Lennox-Gastaut syndrome, in the second quarter of 2015.
Shares in GW are trading up 0.2% at 631.00 pence Tuesday afternoon.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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