Interview conducted by Jason S. Lupoi, Ph.D.
Cannabis has been resurrected as a botanically-based medicine. Although pharmaceutical companies never really seemed to doubt the efficacy of the plant for treating various conditions, the stance of world governments limited the research and development of cannabis medicine. Recently, GW Pharmaceuticals gained FDA approval for their cannabis-derived medication Epidiolex™. This historical occurrence has prompted discussion regarding the rescheduling of CBD.
Another company developing cannabis-derived medications is AXIM® Biotechnologies (AXIM), based in New York and The Netherlands. AXIM concentrates on the research, development and production of cannabinoid-based pharmaceutical, nutraceutical and cosmetic products.Terpenes and Testing Magazine spoke with Lekhram Changoer, MSc., Chief Technology Officer of AXIM, and an organic chemist with over 20 years of experience in sales and marketing, R&D, product development, and quality assurance.
The cannabis used in AXIM’s products, which include chewing gums CanChew+® and MedChew Rx®, is provided by the Dutch Ministry of Health, and is specifically grown by Bedrocan®, the world’s first good manufacturing practice (GMP) cannabis grow house. “When developing medicinal products,” Changoer said, “it is critical to use raw materials that are as pure as possible.” AXIM developed an extraction process by which tetrahydrocannabinol (THC) is microencapsulated, thereby preventing its oxidation. Using well-defined pharmaceutical ingredients, pure components can, therefore, be isolated.
While this extraction method is currently proprietary, AXIM has filed for a patent on the process, and could say that their technique haslimited purification steps, and therefore, uses less solvents than other extraction methods. AXIM’s method also enables purities of approximately 99% cannabinoid.
AXIM manufactures products like suppositories, topical medicinal creams, traditional pills, and the chewing gums. By using a chewing gum to deliver cannabinoids into the body, the liver can be bypassed, thereby providing a faster uptake of the active pharmaceutical ingredients, CBD and/or THC, into the bloodstream. CanChew+® contains 50 mg of CBD and is predominantly targeting patients suffering from irritable bowel syndrome (IBS) while MedChew Rx® contains both THC and CBD and is geared for treating the pain and spasticity associated with multiple sclerosis (MS). MedChew Rx® is the first pharmaceutical, functional chewing gum containing cannabinoids. A third chewing gum pharmaceutical product contains just synthetic THC, called Dronabinol, and targets treating nausea and vomiting associated with chemotherapy and loss of appetite in HIV/AIDS patients.
These products are currently in Phase I of the clinical development, where AXIM assesses whether the level of uptake of the cannabinoid(s) is sufficient enough. Following this trial, as well as their Phase 2 study in Amsterdam, AXIM is planning to bring their products to the EMA (European Medicines Agency) and the US FDA for consideration. In fact, AXIM’s research methods have already kept FDA guidelines in mind, as they have prepared many of the necessary requirements for seeking FDA approval throughout their internal studies. The path for gaining their acceptance by the Dutch Ministry of Health hasn’t been as crag-rooted as what occurs in the US. “We don’t have hurdles to overcome with state and federal governments,” Changoer explained. “This results in a much shorter process, although we still have to show the clinical and statistical efficacy of our products.”
The choice for using a chewing gum delivery system was based in AXIM’s realization of the beneficial, neuroprotective benefits of the act of mastication.”
Future AXIM R&D will encompass the use of molecularly-modified cannabinoids as neuroprotectants and industrial hemp-derived cannabigerol (CBG) formulations for dermatological applications. Other product lines being evaluated are antibacterial cannabinoid preparations (Cannacyn™ and Cannonych™) as well as ophthalmological preparations derived from cannabigerol (CannBleph™, patent pending). AXIM also is currently developing an extraction and freeze-drying technology for production of extremely pure, pharma-grade cannabinoids extracted from industrial hemp.