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GW Pharma Rallies on Positive Stage 3 Clinical Trial Data

Jun 27, 2016 • 12:12 PM EDT
1024px-First_Pigment_Analysis_(5893349712).jpg
2 MIN READ  •  By Michael Berger
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GW Pharmaceuticals plc (GWPH) has once again changed the landscape of the cannabis industry as the company reported its second positive Stage 3 Clinical trial for its Epidiolex product.

The results for this trial were for the treatment of Lennox-Gastaut syndrome (LGS) and Epidiolex was able to significantly reduce the number of drop seizures over a 14-week period when compared to a placebo.

In this study, Epidiolex achieved the primary endpoint of a significant reduction in drop seizures assessed over the entire treatment period compared with a placebo. Epidiolex has both Orphan Drug Designation and Fast Track Designation from the FDA.

Significant Drop in Number of Seizures

The difference between Epidiolex and a placebo emerged during the first month of treatment and was sustained during the entire treatment period.

During the treatment, patients taking Epidiolex achieved a median reduction in monthly drop seizures of 44% compared with a reduction of 22% in patients receiving placebo, a difference that was considered to be statistically significant.

Future Catalysts Ahead  

GW Pharmaceuticals CEO Justin Gover said the company is looking forward to advancing Epidiolex toward the submission of a New Drug Application with the FDA in the first half of 2017.

GW Pharmaceuticals said it is conducting a second Phase 3 dose-ranging trial of Epidiolex for the treatment of LGS, which is fully enrolled at 225 patients.

The second trial has three treatment arms and the company expects to report top-line results from this trial toward the end of the third quarter of this year.

Continues to Execute

This trial follows the announcement in March 2016 of positive results in a pivotal Phase 3 trial of Epidiolex for the treatment of Dravet syndrome.

GWPH is trading above $95 this morning after the shares fell more than 6.5% on Friday. We continue to remain favorable on the company and Technical420 will continue to hold onto shares in its mock portfolio.

 

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Authored By

Michael Berger

Michael Berger is Managing Partner of StoneBridge Partners, LLC and Founder of Technical420.com. Prior to entering the cannabis industry, Michael was an Equity Research Analyst at Raymond James Financial covering the Energy Sector. Michael has been featured in publications such as The Street, Bloomberg, US Money News, and hosts various cannabis events across North America.

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