AXIM Biotechnologies, Inc., a biotechnology company focused on global research, development and production of pharmaceutical, nutraceutical, food and cosmetic products derived from industrial hemp, has announced commencement of clinical development of its leading patented pharmaceutical chewing gum, MedChew RX, for registration as a drug for relieving pain and/or spasticity in patients suffering from with multiple sclerosis (MS).
Once approvals by the FDA (Food and Drug Administration) and its European counterpart EMA (European Medicines Agency) are granted, MedChew RX, which is formulated with 5 mg of the hemp-derived cannabinoids cannabidiol (CBD) and tetrahydrocannabinol (THC) respectively, will be marketed as a pharmaceutical drug for treating multiple sclerosis (MS).
AXIM Biotech notes that traditional cannabinoid delivery methods such as smoking, or the oral/GI route have unwanted side effects and a reduced efficacy. Consequently, the company is targeting chewing gum as a functional vehicle for uptake of cannabinoids via the oral mucosal membrane, observing that gum-chewing is a far superior, safer, and more socially accepted delivery method than for example smoking or vaporizing.
“An ideal cannabinoid delivery method should allow for predictable and controlled release of the active ingredients, which should bypass the first-pass liver metabolism thus increasing the bioavailability of the cannabinoid and decrease inactive or harmful metabolites says Dr. George Anastassov, President of AXIM Biotechnologies, Inc. in a release. “It should not be socially stigmatizing, such as using tablets, capsules, sprays, vapes, etc. It should have a pleasant taste and consistency and lack of undesirable side effects such as uncontrollable psychotropic consequences. It should not induce food cravings and should be economically affordable for both producers and consumers. Chewing gum meets all of these criteria as well as provides multiple additional advantages.”
AXIM Biotech is obtaining its supply of cannabinoid strains from the Dutch Government’s Bureau of Medicinal Cannabis — delivered by the growing facility Bedrocan BV in The Netherlands. AXIM Biotech has developed with its product development partner, Syncom BV, unique extraction and purification methods for the pharmaceutical-grade cannabinoids and already applied for patents for all of these innovations. The multilayer medical chewing gum with cannabinoids is developed at Fertin Pharma based in Vejle, Denmark. Xendo BV is in charge of the regulatory affairs and QPS BV, a clinical research organization based in The Netherlands, is in charge of managing the entire project including the clinical strategy and trials.
“AXIM is pleased to report that the project is on track,” comments Lekhram Changoer, MSc, BSc and Chief Technology Officer of AXIM Biotech. “After having developed the extracted and purified cannabinoids, the MedChew RX drug product is in the process of development whereby different prototypes are developed with a variation of the drug product in different gum layers. This is a very important step in order to create the option to choose for the best drug product after the bioavailability tests in order to assure an effective, sustained release of the drug product in the mucosal membrane area.”
“The phase 1 PK/PD study activities are planned to start in Q2 of 2016, whereby the release profiles of the different chewing gum products will be compared and a decision will be made on PK/PD analysis. This will determine which of the multilayered gum will be tested on efficacy in Phase 2/3 clinical trials on MS patients,” Dr. Changoer continues. “After completion of the Phase 1 study, Phase 2/3 efficacy patient trials will be started at renowned clinical trial centers in The Netherlands, UK, USA, and others. In The Netherlands the studies are carried out at the VU University in Amsterdam and their respective MS center at the department of Neurology.”
Discussing the further benefits of a chewing-gum delivery mechanism, Dr. Anastassov explains that “According to Dr. Roxane Weijenberg, PhD, who is the clinical trial coordinator at the Free University of Amsterdam, besides the obvious pharmacological properties of cannabinoids there is a growing body of evidence suggesting that the act of mastication (chewing) itself has therapeutic effects.” (Weijenberg, R.A., E.J. Chreder, and F. Lobbezoo, Mastication for the Mind-The Relationship Between Mastication and Cognition in Ageing and Dementia. In Neurosci. Biobehav. Rev., 2011.35(3):p. 483-497.)
“This is due to the fact that mastication promotes the following: neurogenesis, hypothalamic-hypophiseal-adrenal axis attenuation, cardiovascular stimulation, enriched environment, and promotion of oral health,” Dr. Anastassov continues. “The positive effects of mastication are acute and long-term. Acute effects include: arousal, cognition, stress reduction and fresh breath. Long-term effects include: prevention of loss of cognition associated with aging, prevention of dry-mouth due to saliva production stimulation, and improved oral hygiene.”
AXIM Biotech is producing a broad range of proprietary delivery mechanisms for introduction of natural components of the cannabis (hemp) plant known as cannabinoids (a class of diverse hemp-derived chemical compounds that act on cannabinoid receptors in cells that repress neurotransmitter release in the brain — e.g. CBD, CBG, THC, and roughly 80 others). AXIM Biotech’s intellectual property, to date, includes many patent applications in various stages of application, with additional inventions to be filed soon, as well as trademark applications; many of them are approved trademarks. All of AXIM’s products are supported by solid intellectual property prior to being produced and distributed worldwide.
As the exclusive license recipient to the world’s first controlled-release chewing gum containing cannabinoids, AXIM Biotechnologies is pursuing two global markets: food with CanChew Plus and pharmaceutical with MedChew RX. Award-winning CanChew gum, a food product, is available today; CanChew Plus is planned to be available soon.
AXIM Biotech’s core mission is grounded in responsibility for environmental stewardship combined with development of innovative products to address current conditions with no known effective treatment, such Parkinson’sdisease, Alzheimer’s disease/dementia, ADHD (attention deficit hyperactivity disorder), PTSD, autism, MS, spasticity, pain, RLS (restless leg syndrome), glaucoma, IBD, IBS and Crohn’s disease. Cannabinoids have been shown both anecdotally and scientifically found to hold encouraging promise in alleviating the suffering caused by those disorders.
AXIM Biotechnologies emphasizes that the company does not sell or distribute any products that are in violation of the United States Controlled Substances Act (US.CSA), but does grow, sell, and distribute hemp-based products, and on July 31, 2015 issued a statement of clarification of its status.
AXIM Biotechnologies Clarifies Relationship With Medical Marijuana, Inc. and CanChew Biotechnologies
“We have received numerous telephone calls from the public leading us to believe there is general confusion relating to our relationship with Medical Marijuana, Inc., and CanChew Biotechnologies, LLC,” says AXIM Biotechnologies, Inc. President Dr. George Anastassov in the statement. “AXIM’s business focus has been and continues to be on being an innovative biotechnology company working on solutions for the treatment of pain, spasticity, anxiety and other medical disorders and symptoms with the application of cannabinoid-based products as well as focusing on research, development and production of pharmaceutical, nutraceutical, oral health and cosmetic products as well as procurement of genetically and nano-controlled active ingredients.”
In its statement the company explains that:
“Medical Marijuana, Inc. (MJNA) is the first publicly held company vested in the medical marijuana and industrial hemp markets. MJNA is comprised of a diversified portfolio of products, services, technology and businesses solely focused on the cannabis and hemp industries. MJNA is a major shareholder of AXIM, holding approximately 47 percent of our common stock, but neither it nor any of its affiliates participate in the management or operations of AXIM in any manner. Sanammad Foundation, a Netherlands based company, also owns 47 percent of our common stock. Sanammad Foundation’s three members, Dr. George Anastassov, Dr. Philip A. Van Damme and Dr. Lekhram Changoer, are AXIM’s three directors and manage AXIM’s daily operations.”
“CanChew Biotechnologies, LLC, holds a US patent for the production of unique time-release cannabinoid-infused chewing gum. On May 1, 2015, AXIM entered into a 50 year, worldwide, exclusive licensing agreement with CanChew wherein AXIM acquired the intellectual property rights underlying the patent to allow AXIM to produce CanChew Plus a unique time-release industrial hemp oil derived CBD (cannabidiol)-infused chewing gum. Medical Marijuana, Inc. financed CanChew’s initial operations and owns 50% of CanChew’s membership interest. However, in accordance with the company’s operating agreement, Medical Marijuana, Inc. does not manage or control CanChew’s operations. Sanammad Foundation owns the remaining 50% membership interest of CanChew and manages daily operations.”
Medical Marijuana, Inc., CEO Stuart Titus adds:
“MJNA and the new leadership has recognized the value of the wonderful leadership that the AXIM team provides. Alongside the new relationship with CanChew Biotechnologies and their patent on chewing gum and cannabinoids — the promise for significant IP, significant new products and pharmaceutical development exists.
“MJNA salutes and supports the team led by Dr. Anastassov in their clinical efforts and believes their delivery method for cannabinoids may provide a well-accepted and therapeutically improved delivery for cannabinoid-based pain medication, via the MedChew clinical trials ongoing in Europe. Recent FDA warnings have shown additional potential side effects from traditional NSAID medications — thus the MedChew trials are quite timely and well-needed. In fact, the FDA equivalent in The Netherlands asked AXIM to specifically carry on these well-needed trials.”
“Although MJNA and our team are not directly involved with these efforts, nonetheless, we strongly support any and all studies for safety and efficacy that the AXIM team is involved with. At MJNA we feel that further research will show the full potential for cannabinoids to the world of medicine — just as many anecdotal stories have shown with the botanical formulations available today.”
For more information about AXIM Biotech, visit the company website at:
AXIM Biotechnologies, Inc.
Medical Marijuana, Inc.