AXIM® Biotech Enters Services Agreement With CRO to Begin Clinical Studies On Dronabinol and CBD Chewing Gums
NEW YORK, April 09, 2019 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (“AXIM”) (“the Company”) (“AXIM® Biotech”) (OTC:AXIM), a world leader in cannabinoid research and development, today announced that it has entered into a Services Agreement with contract research organization (“CRO”) QPS Netherlands BV, a global leader in contract research, to begin separate bio comparison studies with its two leading drug candidates, MedChew® with dronabinol and CanChew® Rx. Both products are chewing gums containing synthetic tetrahydrocannabinol (THC) and cannabidiol (CBD) respectively, and utilize the company’s patented chewing gum delivery mechanism.
The CRO will conduct a two open label single dose studies (varying chew duration and concentration) followed by a double-blind, randomized, multiple dose study to test the bioavailability of dronabinol in MedChew®. MedChew® formulated with dronabinol is intended for treatment of chemotherapy-induced nausea and vomiting in cancer and AIDS patients. AXIM intends to register the product on the basis of a 505(b)(2) application.
An open-label, randomized, 3 period crossover pharmacokinetic study will be conducted by the CRO on AXIM’s CanChew® Rx product. CanChew® Rx is intended to treat symptoms associated with drug-related psychosis.
"Reaching this agreement is a big step in AXIM’s clinical development program as we work diligently on the stages of trials to get our products to those suffering from a range of symptoms," said John Huemoeller, Chief Executive Officer of AXIM® Biotech. "We are proud to work with a well-respected company such as QPS Netherlands that shares our commitment to excellence to bring well-tested and proven drugs to market. They are experts in their respective fields and I am eager to get this study underway and move forward AXIM’s strategic clinical development program."
Cancer is the second leading cause of death worldwide, with economic impact in the United States alone equating to $80.2 billion in 2015. A large number of cancer patients undergo chemotherapy and search for relief from a range of symptoms that often accompanies the treatment.
To learn more about AXIM® Biotechnologies, Inc., visit http://aximbiotech.com/.
About AXIM® Biotechnologies
AXIM® Biotechnologies, Inc. (AXIM) is a world leader in the research and development of cannabinoid-based pharmaceutical and nutraceutical products. Along with building a robust intellectual property portfolio, AXIM is focused on clinical development programs with their drug products that bring more efficacy and/or lower side effects than existing alternatives and require small to medium budgets and timelines to bring to market which presents a high added-value to the pharmaceutical field.
AXIM's flagship products include MedChew® with dronabinol, which is planned to undergo a bioequivalence study in preparation of FDA filing as an alternative to approved Marinol; MedChew® RL, which is planned to undergo clinical trials for treatment of restless leg syndrome; and MedChew® Rx, a combination cannabidiol (CBD)/tetrahydrocannabinol (THC) functional, controlled-release chewing gum that is planned to undergo clinical trials for the treatment of pain and spasticity associated with Multiple Sclerosis (MS). For more information, please visit www.AXIMBiotech.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).
Public Relations Contact:
Chief Executive Officer
Corporate Contact Info:
North American Address:
45 Rockefeller Plaza, 20th Fl.
New York, NY 10111, USA
P. 844 294 6246
Industrieweg 40, Unit B4
3401 MA IJsselstein
Released April 9, 2019