Axim® Biotechnologies Completes First Phase of Pharmacokinetic Clinical Study on Cannabinoid-Based Gum With Dronabinol
NEW YORK, Feb. 18, 2020 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting oncological and cannabinoid research, announced today that it has completed the first phase of its pharmacokinetic clinical study on its cannabinoid-based chewing gum with dronabinol, a synthetic form of tetrahydrocannabinol (THC). The multi-phase study is aimed to understand how cannabis may serve as a treatment for chemotherapy-related symptoms.
The first phase of this study, consisting of 10 healthy human subjects, was performed at the Clinical Trial Center of AXIM’s contract research organization ("CRO") QPS Netherlands BV, a global leader in contract research, with regulatory support from ProPharma Group, a provider of regulatory compliance and medical information services.
The study’s goal was to prove that dronabinol is successfully released from the gum. Each subject received a 5 mg dose of dronabinol in a chewing gum product and was instructed to chew the gum for 40 minutes.
Preliminary results provided evidence that:
- All subjects showed a release of dronabinol starting at 10 minutes, providing evidence of oral mucosal absorption
- In more than half of the study’s subjects, the dronabinol pharmacokinetic profile reflected a sustained released effect for four hours after administration
“We are excited to have completed the first phase of our clinical study and are optimistic about moving forward with the next phase,” said John W. Huemoeller II, Chief Executive Officer of AXIM® Biotech. “We are getting closer every day to proving that our unique delivery method can provide cancer patients with quicker and more efficient relief from their chemotherapy-related symptoms.”
The Centers for Disease Control and Prevention (CDC) recently reported that 650,000 cancer patients in the U.S. receive chemotherapy in an outpatient oncology clinic each year. Chemotherapy, though it has been proven to be an effective treatment to kill cancer cells, causes damage to other cells and tissues in the body, often making patients experience many difficult symptoms such as a weakened immune system, pain, nausea, vomiting, and diarrhea.
With the promising results of the first phase of this clinical trial, AXIM will proceed with the second phase of the study to allow the Company to draw further comparative conclusions. It will be comprised of 20 healthy human subjects who will receive single 5 mg, 10 mg and 20 mg doses of the Company’s dronabinol chewing gum and a single 5 mg Marinol capsule.
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a world leader in the research and development of plant and laboratory-derived cannabinoid and oncological therapeutics. AXIM's proprietary research intends to find new ways to diagnose and treat cancer as well as other conditions, such as the intense side effects of chemotherapy, through innovative pharmaceutical delivery systems, cannabinoid-based active pharmaceutical ingredients, and novel therapeutics.
Currently, AXIM is undergoing clinical studies to its cannabinoid pharmaceutical product, MedChew® with dronabinol and acquiree Sapphire Biotech, Inc.’s diagnostic tool is being used to study the company's enzyme biomarker to detect pancreatic cancer earlier than circulating tumor cells. Learn more here. 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.
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Released February 18, 2020