From the National Cancer Institute (NCI) to the National Institute on Drug Abuse (NIDA), government agencies continue to change its stance pertaining to medical cannabis.
Last year, the NCI updated its website to include various studies that reveal how cannabis may inhibit tumor growth by killing cells. The NIDA revised their April 2015 publication to say that marijuana can kill certain cancer cells and reduce the size of others.
Cannabis Biotech Industry Offers Incredible Potential
The biotech sector will be one of the greatest beneficiaries of the legal cannabis movement and we are favorable on the some of the opportunities within it. Cannabis biotech bellwether GW Pharmaceuticals (GWPH: Nasdaq) has fallen more than 10% from its March highs and we think investors should be keeping a close eye on the shares during this time.
Last week, the American Academy of Neurology (AAN) issued a press release highlighting the positive results from GW’s second Phase 3 study of Epidiolex in children and adults with Lennox-Gastaut syndrome (LGS). The data will be presented after the market closes on Tuesday at the AAN’s Annual Meeting in Boston.
Deep Pipeline of Products to Create Catalysts for Years to Come
We continue to view GW as one of the best cannabis investment opportunities and believe the recent pullback has created a great opportunity for new investors. The company has a 20+ year operating history, a deep pipeline of products in advanced stages of FDA testing, and a balance sheet that is strong enough to support the cost of clinical trials.
2016 was a banner year for GW as the company advanced several clinical programs in its pipeline of cannabinoid product candidates. Earlier this year, GW provided an update on its product portfolio. Highlights include:
• CBDV Phase 2 partial-onset epilepsy study in adults is ongoing as Part A is complete and Part B is underway with data expected mid-2017
• CBDV pre-clinical research is ongoing within the field of autism spectrum disorders. Phase 2 trials expected to commence in the third quarter of 2017.
• The company received the Orphan Drug Designation from FDA for CBDV for the treatment of Rett syndrome
• In December, GW commenced Phase 1 trials for its Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
• The company received the Orphan Drug Designation from the FDA and EMA
• THC:CBD for the treatment of Recurrent Glioblastoma Multiforme (GBM). Phase 1b/2a study has been completed and data is in the first quarter of 2017. The company received the Orphan Drug Designation from FDA
• Sativex Phase 2 study in children with spasticity due to cerebral palsy has been completed and data is in
The Value is in the Plant
We continue to view GW Pharmaceuticals as one of the top investment opportunities within the cannabis sector as it is the only Nasdaq traded company focused on developing treatments from the actual cannabis plant.
Unlike Zynerba Pharmaceuticals (ZYNE) which develop its treatments from synthetic cannabis, GW uses the actual cannabis plant and the benefits of this are reflected in its continued success in FDA trials.
GW’s most significant product in its pipeline is Epidiolex and the company has an orphan epilepsy program in Dravet syndrome, LGS, Tuberous Sclerosis Complex (TSC) and infantile spasms (IS). Since March 2016, the company has:
• Reported positive results in a pivotal Phase 3 Dravet syndrome trial
• Reported positive results in two pivotal Phase 3 LGS trials
• Phase 3 trial in TSC ongoing
• Two-part Phase 3 trial in IS commenced in December 2016
GW has a lot of long-term potential and the company is the clear leader in the cannabis biotech industry. Investors should put GWPH on their radar and watch how the company’s research and clinical trial results not only benefit its shareholders, but the entire cannabis industry.
Authored by: Michael Berger