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AXIM Biotechnologies Advances Dronabinol Therapeutic Equivalence Program Through Purchase Agreement With Noramco
AXIM Biotechnologies Advances Dronabinol Therapeutic Equivalence Program Through Purchase Agreement With Noramco.
About this update from Axim Biotechnologies, Inc.
[{"type":"text","content":"\nNEW YORK, May 15, 2018 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (AXIM) (OTC:AXIM), a world leader in cannabinoid research and development, today announced that it has reached a long-term purchase agreement for pharmaceutical-grade dronabinol with Noramco, a global leader in the production of controlled substances for the pharmaceutical industry.\n The agreement outlines an initial purchase of the Active Pharmaceutical Ingredient (API) dronabinol, which is a synthetic form of tetrahydrocannabinol (THC), to be used in AXIM’s clinical trials for treatment of chemotherapy-induced nausea/vomiting (CINV) and anorexia associated with weight loss in patients with cancer or AIDS. AXIM will microencapsulate the API and formulate it into its proprietary controlled-release chewing gum delivery system, which will go through an open-label clinical study comparing the bioavailability and therapeutic equivalence of the Company’s product to the FDA-approved reference listed drug (RLD) Marinol®. “This relationship marks a pivotal and important milestone for the dronabinol program,” said George E. Anastassov, MD, DDS, MBA and Chief Executive Officer of AXIM. “Partnering with such a well-known supplier will enable us to not only move forward with this clinical trial but make the move to sustained production when we receive approval.” In its current form, Marinol is delivered through a gel capsule where almost all of the dronabinol is metabolized into 11-OH-THC due to the first-pass (liver) metabolism. According to AXIM’s researchers, this may cause significant undesirable side effects for patients including impaired thinking and other adverse reactions. AXIM’s patented controlled-release chewing gum will be designed to largely bypass the first-pass metabolism in the liver with the goal of decreasing side effects for patients. AXIM recently announced the completion of a pre-IND meeting with the Food and Drug Administration (FDA) regarding the therapeutic equivalence study and has received the green light for IND submission to the FDA. The study, which can be found on ClinicalTrials.gov, is a two-part, open-label, randomized cross-over study and will enroll 50 patients aged between 18 and 55 years of age. The study will compare th...