Risk Mitigation Through Diversification
The company announced Tuesday positive top-line results from a mid-stage placebo-controlled study of a proprietary combination of tetrahydrocannabinol, or THC, and cannabidiol, or CBD, for treating glioblastoma multiforme, or GBM. This is seen as the company's baby steps in diversifying its portfolio, having already ventured deep into epilepsy treatment with its Epidiolex.
The company's flagship product Epidiolex, meant to treat treatment-resistant epilepsy, has shown effectiveness and safety across a range of severe epilepsy types. In an investor presentation in January, the company said it expects NDA submission by the end of the first half of 2017. Since then, the company has updated the timeframe to the middle of 2017.
Alan Brochstein, Portfolio Manager at 420 Investor, thinks the changed schedule would mean the filing could happen a little later than June 30.
Positive Mid-stage Results For Glioma
Elaborating on the Phase II trial results, GW Pharma said treating GBM with THC and CBD combo resulted in an 83 percent 1-year survival rate compared to 53 percent for patients in placebo cohort, with the median survival for the THC-CBD combo greater than 550 days compared to 369 days in the placebo group. The combo was well tolerated, although adverse events led to discontinuation in two patients in each group.
GBM is the most common and most aggressive type of malignant primary brain tumor and patients usually succumb to the disease about 15 months after diagnosis. The lack of any long-term treatments has made the FDA and the European Medicines Agency accord Orphan Drug designation for the THC-CBD combo.
Clarifying the mechanism of action, GW Pharma said the THC-CBD combo acts through distinct signaling pathways in glioma. In animal testing, the THC-CBD combo showed good efficacy when combined with temozolomide. In vitro studies revealed that combined administration of THC and CBD led to a synergistic reduction in the viability of U87MG glioma cells when compared to the administration of each cannabinoid individually, the company added.
Brochstein told Benzinga, "Positively, the P2 results for glioma are a step towards diversifying the company."
"Companies with a more diversified product offering are less risky. Right now, it's all about Epidiolex, so any sort of positive pipeline developments are especially helpful. While I expect Epidiolex to be approved and to be a successful drug, biotech approvals and launches don't always meet expectations." Brochstein added.
Separately, GW Pharma reported financial results for the first quarter ended December 2016, reporting a loss of 15.6 million pounds, narrower than the 17.7 million pounds reported a year ago. However, revenues fell to 2.1 million pounds from last year's 3.7 million pound. At the end of December, the company had cash and cash equivalents of 360.2 million pounds, down from 374.4 million pounds.
In pre-market trading, GW Pharma was gaining 2.63 percent to $123.93 after ending Monday's session up 1.75 percent at $120.76.
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