AXIM Biotechnologies, headed by CEO Dr. George Anastassov, M.D., has been studying cannabis and its over 500 chemical compounds for the past 15 years. On May 2, the company announced that its product development partner Quay Pharmaceuticals was granted a Schedule I license to import pharmaceutical-grade cannabis to Great Britain from the Netherlands.
With that license, New York City based AXIM will be able to move forward with testing of its newest cannabinoid product: MedChew Rx, a chewing gum delivery system packed with 5 mg of CBD and 5 mg of THC, used to treat both pain and spasticity associated with multiple sclerosis.
“This is not a confectionary chewing gum,” Anastassov explained in an interview with Cannabis Business Times. “It’s a rather sophisticated, controlled-release functional system for the delivery of APIs [active pharmaceutical ingredients].”
The idea behind the gum is to offer a non-smoking delivery option that has little to no negative side effects, Anastassov continues. Other non-smoking products, such as edibles, can cause problems like paranoia, nausea, vomiting and extreme lethargy (commonly known as a “green out”) as they go through the first-pass metabolism.
“The first-pass metabolism is associated with ingestion of cannabinoids, in particular THC, whereby passing through the liver … it gets degraded to 11-Hydroxy-THC. On the way down, it also gets degraded to other metabolites such as 8- and 9-Hydroxy-THC,” Anastassov says.
When consuming edibles, he says, upwards of 90 percent of the THC is metabolized as 11-Hydroxy-THC. It is those metabolites and their unpredictability that can potentially cause the negative symptoms.
AXIM’s CEO says that by avoiding the first-pass metabolism, the body isn’t going to produce as many metabolites. With this gum, the cannabinoids are absorbed through the oral-mucosal membrane (the inside of your cheeks) and move directly into the bloodstream, avoiding the liver.
Preliminary tests for their gum products have been promising for AXIM: One recent study it conducted using its 50mg CBD gum product showed 76-percent bioavailability of CBD in the patient’s blood after 20 minutes of chewing.
AXIM uses both natural and synthetic cannabinoids in its products. While cultivators might cringe at the thought of synthetic cannabinoids, Anastassov says this is necessary given America’s current regulatory framework.
The FDA requires any compound present at a concentration of over 0.2 percent in any drug be listed and its interactions with other APIs studied. Cannabis has over 140 cannabinoids and over 400 terpenes, “so when someone comes up with a medication which has 2 percent of ‘Others’, those ‘Others’ have to be categorized: Are they different cannabinoids, are they terpenes? The function of the FDA is to protect the well-being of the patients and the consumers, and it’s important to play it safe,” Anastassov says.
It is easier for individual synthetic cannabinoids to get approved by the FDA for the same reason: Synthetic cannabinoids generally have a purity level of over 99 percent, Anastassov says. Most of the natural cannabinoids they work with come from the Netherlands’ Bedrocan. (A few CBG strains come from Italy.) AXIM’s extraction process brings the purity levels of those target cannabinoids to 99.99 percent, according to the company.
AXIM is hoping to start phase 3 trials for its product in early 2018 in the Netherlands, the UK and the United States. With those trials, Anastassov hopes to bring legitimacy to the cannabis plant’s medical uses. He says that many medical claims being made in the cannabis industry are not backed by hard science.
“I think that a product which has gone through the scrutiny of all the regulatory agencies, have proven that they have statistically significant usefulness, it’s safer for the public to go this path. … I’m not saying everything that is out there is not good, but it should go through the very same regulatory pathway as we are going or other companies that have been trying to develop for years a product that is predictably efficient.”
He is quick to add that despite their best efforts and plans, pharmaceutical companies get it wrong just as often as they get it right. Ultimately, however, evidence will bring change.
“I think the governments organizations, as rigid as they are, once the evidence is there, they will change their opinion. At least that’s my hope.”
Photo at top: Bogdan Hoda | Dreamstime.com