GW Pharmaceuticals, the 16-year-old British pharmaceutical company that has focused its energies on the development of pharmaceutical-grade cannabinoid products, has gone through a major transformation according to its fourth quarter, fiscal year-end report. The company’s chief executive officer, Justin Gover, hailed his company’s success with Epidiolex, a highly purified form of the CBD-only cannabis strains that seem to have taken the country by storm in 2014.
The tone of the report seems especially upbeat with the CEO declaring, “In 2015, we expect to complete much of the Epidiolex development program as well as start to build a U.S. commercial presence in anticipation of future launch.”
Mr. Gover noted that the company has “commenced treatment of approximately 200 children,” although his estimate downplays the actual number of recipients. One year ago, while announcing Epidiolex’s designation as an “Orphan Drug” by the Food and Drug Administration (FDA), the company reported there were seven study sites with a total of 125 patients.
This year’s report reveals more than 400 patients at 20 “expanded access sites,” most likely private physicians with several patients each or perhaps acting as a regional Investigational New Drug (IND) holder. Another 200 patients, probably those referred to by Mr. Gover, are receiving Epidiolex at “11 clinical sites in the U.S.” It’s likely these are academic institutions such as Texas Children’s Hospital, the University of California at Los Angeles, New York University and University of California as San Francisco.
These sites are the workhorse studies for GW and offer a chance to administer the drug using “good clinical practices,” whereas the expanded access sites provide only anecdotal evidence since they aren’t controlled in a true scientific sense (i.e. double-blind studies). These studies are dual-edged for GW. Once known as Compassionate INDs, the studies, in GW’s words, “may lead to … clinical trials that are not adequately designed to demonstrate efficacy and could delay or prevent GW’s ability to seek approval of Epidiolex.”
This bit of legalese is theoretically true but Epidiolex has already won Fast Track approval from FDA and barring unforeseen and severe adverse side-effects (which would be immediately reported to FDA) it’s unlikely anything will delay approval of Epidiolex for marketing.
The report also contained information on Sativex, GW’s oral mucosa spray product that is approved in 27 nations (not the U.S.) and currently available in 15 countries for treatment of multiple sclerosis (MS). GW has been testing the drug for pain related to cancer and the drug will enter Phase 3 studies in 2015. Like Epidiolex, Sativex has received Fast Track designation from the FDA for this indication. Surprisingly, GW seems to have backed off from its pursuit of FDA approval to market Sativex for MS in the U.S.
Finally, the GW report highlighted some of its pipeline products with some exciting possibilities. These include another epilepsy drug called GWP42006. It’s also referred to as Cannabidivarin (CBDV) and will begin phase 2 studies in 2015.
A drug listed as “GWP42002:GWP42003” is being studied for use in the treatment of glioma (a brain or spinal tumor) and is advancing to the second phase of testing. Some exciting early data from St. Georges University in London suggests there’s a synergistic effect when combining cannabinoids with radiotherapy.
GWP42003, flying solo, is being studied for the treatment of ulcerative colitis. Initial trials show promising signals of efficacy in patients who completed the course of treatment. The same drug is also being looked at for treatment of schizophrenia but all studies are in Europe.
Lastly, GW has begun looking at type-2 diabetes and its new drug GWP42004. Completion of those studies, all of which are located in the United Kingdom, is expected in 2016.
For those interested in more information about GW’s ongoing and completed studies the best source is the U.S. Government’s ClinicalTrials.gov, a service of the U.S. National Institutes of Health. For general information on GW’s products, check out the GW website.
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