- Source : Press Release
- Date : 2018-05-15
- Event type : Phase 1
- Companies : Noramco Inc., AXIM Biotechnologies, Inc., Johnson and Johnson
AXIM Biotechnologies Advances Dronabinol Therapeutic Equivalence Program Through Purchase Agreement with Noramco
NEW 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 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 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
AXIM® Biotechnologies, Inc. (AXIM) focuses on the research, development and production of cannabis-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 a number of 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.
Noramco, headquartered in Wilmington, Delaware, is a leading North American producer of controlled substances bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry. The company offers cannabinoids and APIs for use in abuse deterrence, attention deficit disorder, pain management, and addiction management. Established in 1979, Noramco maintains production and R&D facilities in Delaware and Georgia (USA); and Neuhausen, Switzerland; and accesses agricultural operations in Tasmania through an affiliate, Tasmanian Alkaloids. Additional information about us can be obtained by visiting our web site at www.Noramco.com.
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.
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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