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News Breaks
March 17, 2014
05:34 EDTGWPHGW Pharmaceuticals provides update on cannabinoid pipeline
GW Pharmaceuticals provided an update on the company's cannabinoid pipeline. GW has completed a Phase 1 clinical trial of GWP42006 to treat epilepsy. CBDV was well tolerated even at the highest tested dose and no significant side effects were observed. There were no serious or severe adverse events, nor any withdrawals due to adverse events, and all mild adverse events resolved on treatment. CBDV has shown the ability to treat seizures in pre-clinical models of epilepsy with significantly fewer side effects than currently approved anti-epileptic drugs1. CBDV also appears to employ a different mechanism of action to currently available anti-epileptic treatments. GW expects to commence a Phase 2 study of CBDV in patients with epilepsy later in 2014, using the doses identified as appropriate in this Phase 1 study. GW also announced that the Intellectual Property Office in the United Kingdom has granted a patent for the use of CBDV in the treatment of epilepsy, patent number GB2479153B. This same patent is currently in prosecution with the USPTO. GW has commenced a 12-week randomized, double blind, placebo controlled Phase 2b study of GWP42004 to treat Type 2 diabetes. The primary objective of this study is to compare the change in glycemic control in participants with Type 2 diabetes when treated with one of three doses of GWP42004 or placebo as add-on therapy to metformin with the primary endpoint being change from baseline to the end of treatment in mean glycosylated haemoglobin A1c level. The safety and tolerability of GWP42004 compared with placebo will also be assessed. This study is expected to enroll approximately 200 patients with an estimated completion date of the second half of 2015. GW has commenced a Phase 2a trial using GWP42003 to treat schizophrenia. GWP42003 has shown notable anti-psychotic effects in accepted pre-clinical models of schizophrenia and importantly has also demonstrated the ability to reduce the characteristic movement disorders induced by currently available anti-psychotic agents. The mechanism of GWP42003 does not appear to rely on the D2 receptor augmentation of standard antipsychotics and therefore has the potential to offer a novel treatment option in this therapeutic area.
News For GWPH From The Last 14 Days
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March 31, 2015
07:08 EDTGWPHGW Pharmaceuticals initiates first Phase 3 pivotal trial for Epidiolex
GW Pharmaceuticals announces it has initiated the Phase 3 part of a Phase 2/3 clinical trial of Epidiolex for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy. GW anticipates that top-line data from this trial will be available around the end of 2015.
March 26, 2015
08:30 EDTGWPHGW Pharmaceuticals risk/reward favorable into data, says Leerink
Leerink says the risk/reward on shares of GW Pharmaceuticals is favorable into the Epidiolex update at AAN on April 22 despite the 34% rally since the last update in October. The firm notes its price target of $102 assumes a 66% probability-of-success for Epidiolex in Dravet/Lennox Gastaut. Changing the probabilities to 100% yields a target of $182, Leerink notes. It reiterates an Outperform rating on GW.
March 17, 2015
07:20 EDTGWPHBofA/Merrill to hold a conference
Smid Cap Conference 2015 is being held in Boston on March 17-18.

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