In June, the Food and Drug Administration (FDA) approved the first medically extracted cannabis-based drug. The oral solution, called Epidiolex, will be used to treat severe forms of childhood epilepsy like Dravet Syndrome and Lennox-Gastaut Syndrome, which cause daily seizures linked to injury and early death.
The disorders are rare, afflicting less than 45,000 people in the United States, but the FDA’s approval of Epidiolex marks a stark shift in federal thinking on the medicinal merits of cannabis. Likewise the United States Patent and Trademark Office recently issued Axim Biotechnologies a patent for its tetrahydrocannabinol (THC) extraction and purification method.
This is significant because an increased availability of pure cannabinoids is essential for future clinical developments. CULTURE was able to catch up with Dr. George Anastassov, CEO of Axim Biotechnologies, who spoke about the new patent, his thoughts on the recent FDA decision and how he envisions the future of cannabis.
When did you first get involved with cannabis?
I’m a surgeon by background, but I’m also the founder of Axim Biotechnologies. We started 15 to 16 years ago as Sanammad Pharmaceuticals, a Dutch-based pharmaceutical company in the Netherlands, and we were looking for safer alternatives to opioids or painkillers. So that’s how we stumbled upon cannabis. We knew it’s been around for thousands of years, so we decided to see if we could find a reasonable delivery method, something not smoked or swallowed, and we looked at chewing gum as a delivery method based on nicotine replacement therapy models.
The FDA recently approved the first cannabis-derived drug, which uses CBD. Likewise, your company recently received a U.S. patent for its THC extraction method. What’s your take on the FDA’s decision, and how do you see the future of cannabis?
I think this is a fundamental shift in FDA thinking, because this is the very first cannabis-based product, and I’m talking medically extracted because, as we know, we’ve had Marinol on the market since 1985. Again, I think this is an amazing decision by the FDA, but it is very well supported, because GW Pharmaceuticals [has] presented ample data from world-clinical leaders, and it unequivocally shows that the medication is efficient. It’s effective, and it improves the symptoms of these rare and horrible diseases like Dravet Syndrome which, unfortunately, have no effective treatments, let alone a cure. I mean, these are children who have sometimes in excess of 300 seizures a day, and Epidiolex is making a tremendous difference, almost 40 percent improvement, which is quite significant. In a way, I think it would be inhumane for the FDA not to approve this medication.
Can you tell me more about the clinical development process for cannabis-based pharmaceuticals?
As of today, cannabis is a Schedule I substance, so you need to have a Schedule I permit from the FDA, and everywhere the regulatory landscape is different. I would say today the best regulated [clinical development process] is in the Netherlands and also Israel and, as of late, Canada. But in the United States there is only one legal facility that produces cannabis and that is at the University of Missouri and the quality of this cannabis, which is supervised by the National Institute on Drug Addiction (NIDA), is extremely poor. There is only one company in the world that has GMP [certification], which is good manufacturing practices, and this is Bedrocan from the Netherlands, which we have been working with for the past 15 years or so.
“In a way, I think it would be inhumane for the FDA not to approve this medication.”
Your latest patent involves the extraction of “pure THC molecules.” How does your extraction method differ from others?
The difference between our technology and the synthetic pathway is the steps involved. If we’re talking about synthetic THC, it is an extremely lengthy process with many, many steps involved and in our case it’s just a few steps, which produces the same quality, but I would say probably better because it’s organic, naturally extracted and it’s from the best plant, if you will, on the face of the Earth. […] Also the thing about the process of synthesis is that it can have unpredictable consequences. So when we work with synthetics it’s a difficult process, a multistep process and it’s [an] expensive process. Our process produces a product, which is just as pure as synthetics but it’s cheaper by a factor of 10.
What’s next for Axim Biotechnologies?
We have a rather deep pipeline. We have an expansive portfolio of intellectual property and trademarks, but it doesn’t mean we are working on all of these projects at once. Our most advanced project is MedChewRx™, and we hope to complete phase three by the first quarter of 2019. We’re also working on an analog to Marinol. The problem with Marinol is that it’s in a capsule and when the capsule is swallowed with the oil inside, it goes to the gastrointestinal tract then it passes through the liver and then breaks down into multiple metabolites, and one of them is extremely toxic which is, 11-Hydroxy-THC. So we are developing a product that will utilize, again, a control released chewing gum with the intent to deliver the medication to the oral mucosa and this way it will largely bypass the [gastrointestinal] tract. Whether this will happen, time will tell, but it’s another way we are moving forward.