In the meeting, the Company and the Dutch authorities discussed the overall development plan for MedChew Rx in the country and across Europe.
AXIM Received Guidance and Approval on Its MedChew Rx Clinical Development Program from Dutch Authorities, Achieving Another Major Milestone for the Company’s European Market Expansion
NEW YORK, Jan. 23, 2018 (GLOBE NEWSWIRE) -- Axim Biotech (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).
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 acceptability of its product and reducing the variability between individuals and the number of administrations over the day.
About AXIM®
AXIM® Biotechnologies, Inc. (AXIM) focuses on the research, development and production of cannabinoid-based pharmaceutical, nutraceutical and cosmetic products. Our flagship products include CanChew+®, a CBD-based controlled release chewing gum, CanChew+ 50®, containing 50 mg of CBD undergoing clinical trials in patients with IBS and MedChew Rx®, a combination CBD/THC gum that will undergo clinical trials for the treatment of pain and spasticity associated with multiple sclerosis. AXIM has several products developed or in developmental stage for treatment and/ or prevention of multiple conditions and symptoms. We prioritize the well-being of our customers while embracing a solid fiscal strategy. For more information, please visit AXIMBiotech.com.
FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Axim Biotechnologies, Inc. to be materially different from the statements made herein.
LEGAL DISCLOSURE
AXIM® Biotechnologies does not sell or distribute any products that are in violation of the United States Controlled Substances Act (US.CSA).
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