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AXIM Biotechnologies Advances Dronabinol Therapeutic Equivalence Program Through Purchase Agreement With NoramcoNEW 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. 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 f 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 the bioavailability of the two different dronabinol formulations and is expected to start soon. The global market for dronabinol was $160 million in 2016 and is expected to grow dramatically based on increased drug availability, a change in public opinion toward medical cannabis, new methods of drug delivery and the results from new clinical trials, as reported by Zacks Small-Cap Research. According to Insys Therapeutics, the current annual market for dronabinol is approximately 280,000 prescriptions with a potential addressable population of roughly 800,000 in CINV and 90,000 in AIDS anorexia. About AXIM® Biotechnologies About Noramco FORWARD-LOOKING DISCLAIMER Public Relations Contact: Corporate Contact Info: European Address: |