AXIM Biotech Advances Programs Through Traditional Biotech Pathways, Positive Meeting with FDA
December 13, 2017 12:46 pm ET
Imagine waking up in the morning, experiencing stomach cramps, and feeling like you have to be near a bathroom at all times. When leaving the house to work, you must take routes that you know will have public restrooms along the way. This is a reality for up to 20% of American adults that suffer from irritable bowel syndrome (IBS) at some point in their lives, although doctors don’t know what causes it and there are no cures for the condition.
In this article, we will take a look at why cannabinoids could play a role in treating the condition and AXIM® Biotechnologies Inc.’s (OTCQB: AXIM) promising clinical trial in the space, as well as the company’s work in other areas.
Treating IBS with CBD
Cannabidiol (CBD) is a non-psychoactive cannabinoid found in cannabis or hemp plants that may be effective in treating a wide range of medical conditions, including arthritis, diabetes, alcoholism, MS, chronic pain, schizophrenia, PTSD, depression, antibiotic resistant infection, epilepsy, and other neurological disorders. According to Google Scholar, more than 2,300 studies have been published mentioning CBD in 2017 alone.
CBD has been shown to reduce inflammation by acting on the human body’s endocannabinoid system that regulates inflammatory responses, among other things. CB1 receptors are located primarily on central and peripheral neurons, while CB2 receptors are concerned with immune function, inflammation and pain. By influencing these receptors in various ways, cannabinoids have the potential to treat many conditions.
In terms of IBS, early research suggests that CBD targets enteric reactive gliosis, counteracts the inflammatory environment induced by lipopolysaccharides in human colonic cultures derived from ulcerative colitis patients, and reduces intestinal damage mediated by the PPAR-gamma receptor pathway. Researchers believe that the modulation of the gut endogenous cannabinoid system could provide a useful therapeutic target for disorders of gastrointestinal motility.
AXIM’s Clinical Trials
AXIM Biotechnologies Inc. (OTCQB: AXIM) has become a leading developer of CBD-based therapeutics leveraging innovative delivery systems. Its flagship delivery system is a chewing gum that provides patients with a convenient way to consume cannabinoids that are delivered over an extended period of time. In addition, the act of chewing (mastication) has many benefits of its own without the side effects associated with smoking.
In a Phase II trial conducted at Wageningen University in the Netherlands, the company’s CanChew+ CBD functional, controlled release chewing gum was evaluated for the treatment of IBS using Rome III criteria. The study found that CanChew+ was well-tolerated by the IBS patients with no side-effects, while those taking CanChew+ experienced a 50% higher pain reduction than patients on placebo.
“We are excited to see clinical evidence on our theory on the therapeutic effects of CBD gum and mastication on IBS patients,” said Dr. George Anastassov, CEO of AXIM Biotechnologies, in a recent press release. “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.”
“Clinical improvement was seen in patients who also indicated that they would like to continue using the product,” said Professor Renger Witkamp, who led the study. “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.”
Expansion into Other Areas
AXIM Biotech has a diverse clinical pipeline that aims to take a similar approach to advance CBD-based compounds through conventional clinical trials.
The company recently announced the successful completion of a pre-investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration for a dronabinol-based functional, controlled-release, chewing gum product to help treat patients with chemotherapy-induced nausea and vomiting and AIDS patients experiencing appetite and weight loss. Management will now focus on filing an IND with the FDA for the product.
The company also announced earlier this year that it entered into a Term Sheet Agreement with a U.S.-based controlled substances API production company to develop the dronabinol-based chewing gum. The new product could have significantly more bioavailability than the existing Marinol brand, which is a gel capsule where 90% of the API is metabolized by the liver and can cause significant side effects for patients.
“We are very pleased with the outcome of our pre-IND meeting with the FDA, which enables us to discuss our planned IND content and obtain guidance for clinical development of this dronabinol-based chewing gum that we believe could truly be a breakthrough for those who suffer from the side effects of Marinol,” said Dr. Anastassov. “After getting the green light from the FDA, our team will now be working diligently towards the submission of our IND, another major milestone in getting this product to shelves.”
AXIM Biotechnologies Inc. (OTCQB: AXIM) represents a compelling investment opportunity in the emerging cannabis industry. With its CanChew delivery technology in place, the company has developed a diverse clinical pipeline targeting a number of medical conditions with both prescription and over-the-counter products. Investors may want to take a closer look at the stock as it begins to announce clinical trial results and moves closer to regulatory approvals.
For more information, visit the company’s website at www.aximbiotech.com.