AXIM Biotechnologies says it plans to proceed with clinical trials for its flagship drug candidate, the cannabinoid-containing chewing gum MedChew Rx®, after receiving a GMP manufacturing license from the Netherlands’ Ministry of Health, Welfare and Sport.
The license, which took effect October 1, will enable AXIM to produce its cannabinoid-based pharmaceutical drug candidates for human clinical trials for multiple indications.
“It’s a major milestone for the development of the company,” AXIM CEO George E. Anastassov, M.D., D.D.S., told GEN.
He said production of MedChew has already begun, outsourced to U.K.-based Kay Pharma, for use in a Phase III trial to be launched soon. “We hope everything goes according to plan to complete the Phase III in the first quarter of 2019.”
MedChew Rx, a gum combining cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC), will undergo clinical trials assessing its safety and effectiveness in treating pain and spasticity associated with Multiple Sclerosis (MS).
On August 7, AXIM announced positive stability and dissolution tests showing that the primary active pharmaceutical ingredients (APIs) in MedChew Rx remained stable throughout the test and that the availability of the APIs was greater than 90%.
MedChewRx uses AXIM’s microencapsulation technology, designed to keep molecules stable in their formulation.
Since the volatile THC molecule can be degraded by factors that include room temperature and light, development of the microencapsulation process was a key challenge toward securing GMP licensing.
“It took us quite a bit of time to make sure we had a product that was stable and retained its active compound at more than 90%. These are complicated processes. We started 15–16 years ago, before AXIM was AXIM,” Dr. Anastassov said. “I would say it took us four years to arrive at the level that was required to achieve this licensing and certification.”
Managing the Supply Chain
MedChew Rx will use a methodology the company developed for extracting and purifying THC for which AXIM in June won an allowance for its U.S. patent application 15/146,668. AXIM says that process will allow it to manage its own supply chain for the company’s clinical products, as well as create and deliver safe and consistent pharmaceutical drug candidates for use in clinical trials.
Last month, AXIM won FDA pre-IND approval for bioequivalence studies assessing MedChew-Dronabinol—a variant of MedChew containing dronabinol—for comparability to AbbVie’s marketed cannabinoid Marinol® (dronabinol). Marinol is indicated for the treatment of anorexia and weight loss in adults with AIDS, and for nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatment.
AXIM plans to develop MedChew for additional target indications that include drug-related psychosis, restless legs syndrome, irritable bowel syndrome, Parkinson’s disease, and dementia, Dr. Anastassov said.
In addition to conducting research in the Netherlands, the company will also produce and export pharmaceutical candidates to other countries for continued clinical research with the prospect of bringing these products to market worldwide.
AXIM entered the Canadian market in August, and the Australia/New Zealand market last month, through distribution agreements, respectively. And in April, AXIM reached a preliminary agreement for the distribution of its CanChew and MedChew products throughout South Korea.
Headquartered in New York, AXIM was incorporated in Nevada in 2010 as AXIM International, and took its current name in 2014—the year Dr. Anastassov joined the company along with partners Philip A. Van Damme, D.M.D., M.D., Ph.D., who is the company’s CMO; and Lekhram Changoer, the company’s CTO. All three had been founders and board members of Sanammad Foundation, which along with MJNA Investment Holdings, a subsidiary of publicly-traded Medical Marijuana Inc., hold a majority of AXIM stock.