Axim Biotechnologies Announces Phase IIa Trial Results Validating its Proprietary Cannabinoid Delivery Method for Treatment of Irritable Bowel Syndrome (IBS)
Participants of AXIM Biotech’s Phase IIa trial experienced a decrease in their pain score and improvement in their quality of life score, highlighting the efficacy of AXIM’s patented CBD chewing gum delivery method, allowing for AXIM to move forward with further trials with predetermined dosing
NEW YORK, Nov. 21, 2017 (GLOBE NEWSWIRE) -- AXIM® Biotechnologies, Inc. (AXIM® Biotech) (OTC:AXIM), a world leader in cannabinoid research and development, today announced clinical trial results from its first phase II pilot trial for the treatment of irritable bowel syndrome (IBS) with the company’s CanChew +® CBD (cannabidiol) functional, controlled release chewing gum.
The study, which was conducted at Wageningen University in The Netherlands, was a randomized, placebo controlled, double-blind, cross-over trial aimed at investigating acceptance and overall pain reduction. Enrolled patients suffered from IBS according to the Rome III criteria, as diagnosed by their own physicians. To be included, it was also necessary that patients experienced, according to their own account, at least three pain episodes per week of a predefined intensity (measured by VAS-score). After a one-week run-in period to record baseline parameters, patients received either CanChew+® (with 50 mg CBD) or active placebo chewing gum for periods of 3 weeks each, with a one-week “off” interval in between. Participants were asked to record effects on pain by visual analogue scale (VAS) and to fill out questionnaires on perceived quality of life (QOL) and bowel habits at regular time points.
Study results indicate that CanChew+® was well tolerated by the IBS patients and no significant adverse side effects were observed by any participants of the trial. All patients who participated in the study experienced decrease in their levels of pain score. On top of the overall reduction, the trend curve suggests 50% higher pain reduction when patients were on CanChew+® compared to the active placebo, which suggests that CBD content did lend to a decrease in pain score. As overall pain scores were reduced, the study also validates AXIM’s use of its proprietary chewing gum delivery system.
“We are extremely excited to see clinical evidence of our theory and the therapeutic effects of CBD gum and mastication on IBS patients,” said Dr. George Anastassov, CEO of AXIM Biotechnologies. “We learned a great deal from this pilot study that will help us to construct the next steps in our IBS program. We plan to extend this study as an open-label trial for prolonged duration and with set dosing and intervals. This will allow us to analyse the effects of controlled dosing on symptom management.”
IBS is the most common gastrointestinal disorder with a prevalence worldwide ranging from 9-23%. Complaints include abdominal discomfort or pain and altered bowel habits. Although the condition is not life-threatening, it strongly impairs quality of life and up to now there is no cure for IBS. Cannabidiol (CBD) is a non-hallucinogenic compound which naturally occurs in the hemp (Cannabis) plant. For more information on the IBS trial, please see: https://clinicaltrials.gov/ct2/show/NCT03003260
“These results are highly encouraging,” said Professor Renger Witkamp, and Chairman of Pharmacology and Nutrition, who led the study at Wageningen University. “We know that IBS shows considerable variation in clinical symptoms. Notwithstanding the short treatment period and differences in the number of gums taken by our participants, clinical improvement was seen in patients who also indicated that they would like to continue using the product. These findings merit further studies of longer duration and larger study groups. What we also learned from the analysis is that people are more likely to benefit from the product when they take a fixed daily dose instead of taking the chewing gum on perceived demand.”
Next to IBS, Axim Biotechnologies and Wageningen University anticipate further trials with chewing gum and other proprietary delivery systems to treat indications such as inflammatory bowel disease (ulcerative colitis and Crohn’s disease).
AXIM® Biotechnologies, Inc. (AXIM) focuses on the research, development and production of cannabis-based pharmaceutical, nutraceutical and cosmetic products. Our flagship products include CanChew Plus™, a CBD-based controlled release chewing gum containing 10mg of hemp-derived CBD, CanChew+ 50™, containing 50 mg of CBD undergoing clinical trials in patients with IBS, and MedChew Rx™, a combination CBD/THC gum that is undergoing clinical trials for the treatment of pain and spasticity associated with multiple sclerosis. We prioritize the well-being of our customers while embracing a solid fiscal strategy. For more information, please visit 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).
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Released November 21, 2017