GW Pharma Rallies on Positive Stage 3 Clinical Trial Data

06/27/2016 9:49 am EST

Focus: CANNABIS INVESTMENTS

Michael Berger

President & Founder, Technical420.com

Michael Berger is a leading expert on the cannabis sector, a market that is just in its early stages of development. Here, the Associate Editor of MoneyShow.com highlights his favorite cannabis stock, GW Pharmaceuticals.

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 a placebo, a difference that was considered to be statistically significant.

Future Catalysts Ahead
GW Pharmaceuticals CEO Justin Gover said the company is now 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 $100 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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By Michael Berger, Editor of MoneyShow.com

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