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AXIM Biotech Announces Successful Completion of Exploratory Meeting with the Dutch Medicines Evaluation Board on MedChew Rx Program for Treatment of Pain and Spasticity in MS Patients
AXIM Biotech Announces Successful Completion of Exploratory Meeting with the Dutch Medicines Evaluation Board on MedChew Rx Program for Treatment of Pain and Spasticity in MS Patients.
About this update from Axim Biotechnologies, Inc.
[{"type":"text","content":"\n\n NEW YORK, Jan. 23, 2018 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (OTC:AXIM), the world leader in cannabinoid research and development, announced today that it has successfully completed an exploratory meeting with the Dutch Medicines Evaluation Board on its MedChew Rx® clinical development program, which utilizes cannabinoid molecules for treatment of patients experiencing pain and spasticity associated with multiple sclerosis (MS).\n In the meeting, the Company and the Dutch authorities discussed the overall development plan for MedChew Rx in the country and across Europe, including its delivery method, production process, and what further studies need to be conducted to bring the product to market. The Dutch regulatory agency expressed enthusiasm about AXIM’s proprietary functional chewing gum delivery method and accepted the concept of using this as an alternative option to oral-mucosal spray, which is the delivery method being used by the only other cannabinoid-based medicine currently registered in the country and in Europe. Additionally, an agreement was reached by the two parties to perform a clinical study comparing the performance of MedChew Rx with the other approved medication in patients with multiple sclerosis as part of the development plan. AXIM also received approval on its proprietary method of production that renders a highly purified API product with steady levels of tetrahydrocannabinol (THC) and cannabidiol (CBD). Approval of this production process illustrates AXIM’s capacity to be a world leader not only in research but also in the production of cannabinoid-based pharmaceutical quality molecules. “We are extremely pleased with the outcome of our meeting with the Dutch regulators who provided us with guidance and the approvals necessary to move forward with clinical development of our MedChew Rx pharmaceutical product,” said George E. Anastassov, MD, DDS, MBA, and Chief Executive Officer of AXIM Biotech. “This meeting marks an important step toward securing a solid strategy for marketing Axim’s cannabinoid-based chewing gum in all countries throughout Europe and beyond.” Under the guidance of the Dutch Medicines Evaluation Board, AXIM will move its MedChew Rx program forward into a Phase I study on healthy volunteers, aiming to confirm the...