Cannabis biotech bellwether, GW Pharmaceuticals (GWPH) announced positive top-line results from an exploratory Phase 2 placebo-controlled clinical study of a proprietary combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) in 21 patients with recurrent glioblastoma multiforme (GBM).
Concurrent with this announcement, the company also reported first quarter financial results for the period that ended on December 31st. GW Pharma continues to be a leader within the cannabis biotech sector and today’s announcement further solidify its position at the top.
About the Study
GBM is a particularly aggressive brain tumor, with a poor prognosis. GW Pharma was granted the Orphan Drug Designation from the FDA and the EMA for THC:CBD in the treatment of glioma.
The study showed that patients with documented recurrent GBM treated with THC:CBD had an 83% one-year survival rate compared with 53% for patients taking the placebo. The median survival for the THC:CBD group was greater than 550 days compared with 369 days in the placebo group.
The treatment was generally well tolerated with the patients in both groups. The study reported that emergent adverse events caused two patients in each group to discontinue the study. The most common adverse events reported were vomiting and dizziness.
From the Principal Investigator and the CEO
Professor Susan Short, PhD, Professor of Clinical Oncology and Neuro-Oncology at Leeds Institute of Cancer and Pathology at St James’s University Hospital and principal investigator of the study said, “The findings from this well-designed controlled study suggest that the addition of a combination of THC and CBD to patients on dose-intensive temozolomide produced relevant improvements in survival compared with placebo and this is a good signal of potential efficacy. Moreover, the cannabinoid medicine was generally well tolerated. These promising results are of particular interest as the pharmacology of the THC:CBD product appears to be distinct from existing oncology medications and may offer a unique and possibly synergistic option for future glioma treatment.”
2017 Outlook is Bright
Following the company’s earnings report, GW Pharma CEO Justin Gover said, “As we look forward to 2017, our primary focus is on completing the Epidiolex NDA, which we expect to submit to the FDA in the middle of this year. With three positive Phase 3 trials delivered in 2016, we remain confident in the prospects for Epidiolex’s approval and are accelerating our preparations for a highly successful launch. Beyond Epidiolex, the value of GW’s cannabinoid platform is further illustrated by promising new clinical data in the field of oncology and we continue to advance a number of additional clinical programs that will yield data this year.”
Trades on FDA Results, Not Earnings
Although GW Pharma reported a $19.3 million net loss on $2.5 million in revenue during the quarter, we remain very favorable on the company as biotech stocks tend to trade on FDA results, not earnings.
As of December 31st, the company reported to have $444.6 million in cash and cash equivalents. This should provide the company enough capital to execute on 2017 corporate initiatives.
We are favorable on this update and continue to view GWPH as one of the top investment opportunities for cannabis investors due to its deep pipeline of products that are in advanced stages of FDA testing. The company’s pipeline should create catalysts for years to come and this is a stock every investor should watch.