AXIM CEO George Anastassov discusses the recent cannabinoid industry developments; providing his views on the future of industry and how this could go toward changing opinions on the use of cannabis in the production of pharmaceuticals.
George E. Anastassov is the Chief Executive Officer, Chief Financial Officer and the Secretary of AXIM Biotechnologies, Inc. (NY, USA). Prior to this appointment, Anastassov was one of the founders and the CEO of CanChew Biotechnologies, LLC and is one of the founders, as well as a Board Member and a general partner, of Sanammad Foundation and Sanammad Pharmaceuticals (The Netherlands).
Anastassov has been actively involved in research and development in medicine and biotechnologies since 1987. He is one of the developers of the first chewing gum delivery system for cannabinoids.
Anastassov is trained in general surgery, oral and maxillofacial surgery, plastic surgery and craniofacial surgery both in the USA and Europe, as well as possessing an executive MBA. He has a variety of clinical and administrative appointments including Associate Clinical Professor of Maxillofacial Surgery, The Mount Sinai School of Medicine; Associate Director, Department of Maxillofacial Surgery, Elmhurst Hospital Center; Attending, Department of Maxillofacial Surgery, Mount Sinai Hospital; Consultant in Maxillofacial Surgery, Bronx VA Hospital Center and Attending Surgeon, Department of Otolaryngology/Head and Neck Surgery, Beth Israel Medical Center (all NY, USA). He also is a Visiting Professor, Department of Cranio-Maxillofacial Surgery and Plastic and Reconstructive Surgery, University of Münster (Germany).
Anastassov has published chapters in three professional textbooks as well as research or articles in 46 peer-reviewed journal publications. He holds nine USA and European professional society memberships and is double board certified.
Please can you give an overview of recent events in AXIM’s pipeline?
The most recent event is the pre-Investigational New Drug (IND) meeting with the US FDA regarding a dronabinol product, which will be a bioequivalent study for a product based on a synthetic Tetrahydrocannabinol (THC). It will be bioequivalent to Marinol, which has been available on the market in the USA since 1985 and is a schedule III product.
Our product has a different delivery system; it’s a totally different technology. Dronabinol is a THC suspended in sesame oil; ours is in alcohol and is microencapsulated and delivered in the form of a functional control release chewing gum.
We’ve just signed a long-term contract with Bedrocan, a major active pharmaceutical ingredient (API) manufacturer and we will be using their dronabinol, which is naturally extracted and 99.9% pure, for this particular chewing gum.
Our multiple sclerosis (MS) project, MedChewRxTM, is moving full-speed ahead; it’s also a functional chewing gum but it contains both THC and cannabidiol (CBD), which are botanically extracted. Of course, for it to be registered by the European Medicines Agency (EMA) and the FDA it has to meet certain purity criteria. This product is 99.9% pure, with the same purity as the synthetic THC or CBD. In this study, we hope to complete Phase III before the end of the year or at the latest the end of first quarter of 2019.
We have completed an irritable bowel syndrome study Phase II with a different product – 50mg of CBD. We intend to move to Phase III with this project as well. We have also just finished formulating a CBD combination product for the treatment of patients with restless leg syndrome.
We are waiting for approval from Health Canada, the equivalent of the US FDA, for a study in patients with drug-related, drug abuse psychosis, which will be with large doses (300mg) of CBD. We’ve also completed the proof-of-concept study in dermatological indications – psoriasis, eczema and vitiligo. That’s quite an encouraging study where we use the chewing gums in combination with topical preparations based on cannabigerol (CBG) and CBD.
These are the most recent events, so there is lots of formulating of products, and lots of product being developed.
If Phase III trials are completed by the end of this year, when do you think the products would be likely to get FDA approval?
The US FDA is a regulatory agency and they’re not very predictable. I think the shortest path to market will be the dronabinol product because bioequivalent studies are shorter and not as demanding as a full swing Phase I through Phase III. My hope is that the dronabinol gum will be registered within 12 months. As for the MS product, I am not as optimistic. I would say it will probably take 18–24 months because there’s a lot of data compilation and it’s not that easy to register a drug.
There’s a product for MS that is EMA approved but not yet FDA approved that is available in 29 countries and is based on cannabinoids. It’s been on the FDA’s desk since 2007 and, most probably, one of the reasons it’s not yet been approved is its high impurity levels.
Bedrocan is the only company in the world that has a current Good Manufacturing Practice cannabis plant, it’s based in Holland and we’re working with them.
How do you think this will affect the future of the industry?
The more products based on cannabinoids that are registered, the more interest there will be in the plant. Still, internationally, cannabis is a Schedule I listed substance, even though there has been a synthetic THC product available in the USA since 1985.
As we register more products, the industry will definitely grow and expand because the plant is truly amazing and there are a lot of unmet needs, which we hope it will address. As the applications increase and grow, so will the interest in the plant, and there’ll be new indications that are currently not addressed with the available preparations, so I think that’s where the industry will be going.
There is no doubt that Sativex works but it’s not approved for pain – it’s approved for spasticity in MS. Our goal is to have a pain designation alongside the spasticity. That’s why most of the preparations we are working on rotate around the word pain – whether it’s abdominal pain or muscle pain. Pain is important, especially now that there’s the worldwide opioid crisis, which we can probably safely call a pandemic.
I think that there is a need to come up with much safer preparations for treatments of pain than what is available today, whether it’s steroidal or opioids, and I think that’s where we will be heading. Does that mean that narcotics will go out of the market? Of course not because there is nothing that is as good as opioids for acute pain, but unfortunately, narcotics are not just used for acute pain but just about any pain. I think that’s what has created the problem, and the analgesics market will be addressed by cannabinoids, especially with the treatment of chronic conditions. Opioids are here to stay but hopefully will be much safer, lower doses and in combination with other molecules such as cannabinoids, and that’s what we’re working on.
How do you think these developments are changing the public’s perspective on cannabis?
It’s been around for thousands of years and it’s very unfortunate that for the last 70+ years there hasn’t been much research done into the plant. It has a therapeutic index approximately 4000x broader than aspirin so it can be considered a safe plant.
I think the public’s perception will change as more data are available from controlled clinical trials. Then again, let’s not forget that the path from plant to a final formulation is very long and this is such a complicated plant. Over 160 different cannabinoids have been discovered up to date and maybe even more than that. It also contains 30 antioxidants.
I believe that there are two distinctive parts involved with the cannabis plant. One is the adult, or recreational, use and the other one is truly pharmaceutical. There is talk about medical cannabis; however, I don’t think there is such a thing because for something to be medical, it has to go through certain regulatory pathways, whether that’s the FDA or the EMA. For something to be called medical, it has to be registerable. I don’t know whether the recreational use is going to be reduced – that’s a political issue with that we are not involved in at all, but as far as the pharmaceutical potential of the plant, I think it is truly limitless.
The opinions expressed in this interview are those of the interviewee and do not necessarily reflect the views of Future Science Ltd.