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AXIM Biotechnologies (AXIM) Advancing Multi-faceted Medical CBD and THC Pipeline

03/20/2018


OTC:AXIM

Summary
• AXIM Biotechnologies (OTC:AXIM) holds the intellectual property rights to the controlled-release, trans-mucosal (chewing gum) drug delivery platform for medical cannabinoids.
o The company is pursuing several indications:
• Irritable bowel syndrome (IBS) – Phase 2
• Pain management associated with multiple sclerosis (MS) – Phase 1
• Bioequivalence trial versus Marinol® (aka dronabinol) 
• Restless leg syndrome (RLS)
• In addition to the company’s proprietary trans-mucosal delivery system, AXIM is in the process of developing trademark-protected formulations with other methods of delivery:
• topical ointment for psoriasis/atopic dermatitis (ReneCann®)
• suppositories for inflammatory bowel disease (SuppoCann™) and 
• ophthalmic solutions for glaucoma and dry eye (OphtoCann™ and CannBleph™)
• News on ongoing and completed clinical studies should drive increasing investor interest in medical cannabinoid stocks in general and AXIM in particular. 
• AXIM Biotechnologies, a clinical-stage medical cannabinoid company, is focused on medical cannabinoids delivered by the company’s novel drug delivery systems, all of which are well positioned to benefit from the overall medical cannabinoid investment theme. 
• AXIM holds three patents (two related to cannabinoid chewing gum and one for a cannabinoid ophthalmic solution), multiple filed IP -applications and 22 trademarks.
• During 2018, AXIM is expected to achieve significant milestones.
o Within the next 12-to-18 months, management anticipates completing several studies:
• a Phase IIB trial with CanChew+ 50 for IBS at the University of Wageningen
• Phase I through Phase III trials with MedChew Rx for the treatment of chronic pain and spasticity associated with multiple sclerosis
• a bioequivalence study of MedChew Dronabinol® chewing gum to Marinol® for the treatment of CINV and for HIV/AIDS patients experiencing loss of appetite and weight

The Value of Drug Delivery Systems 

Novel drug delivery systems (NDDS) can improve not only a drug efficacy, but also a patient's quality of life through various means, such as improving the ease-of-use by modifying the drug’s release profile or enhancing the dispensing method. Traditional methods of drug delivery (standard oral pills and injections) can be improved. In the case of an oral pill or tablet, the speed of onset can be modified from immediate-release to a controlled, sustained release, which stabilizes the amount of drug in the bloodstream (thereby improving efficacy) and also contributes to patient convenience, compliance and safety. Novel drug delivery platforms can alter and improve the dispensing method to improve absorption and the consistency of release. Non-invasive routes of administration are preferred, namely, peroral (through the mouth aka PO), topical application (through the skin) and transmucosal (via nasal/inhalation, sublingual, ocular, rectal and vaginal routes). 

Drug delivery systems can be the driver for value creation of pharmaceutical companies. For example, ALZA Corporation developed pharmaceuticals by enhancing their therapeutic value through advanced delivery technologies. Initially developing transdermal delivery platforms (most notably the NicoDerm patch), ALZA later utilized osmotic technology to control the rate of release of oral medications. This OROS controlled-release technology was the key to developing Procardia XL tablets for angina and hypertension and Glucotrol XL for the treatment of Type II diabetes. ALZA also developed drug delivery systems employing implantable and liposomal technologies. Ultimately, Johnson & Johnson acquired ALZA in 2001 for $10.5 billion.

Drug Delivery Platforms in the Cannabinoid Space 


In the CBD space, several high profile biotechnology companies are pursuing the development and commercialization of medical cannabinoid products with novel drug delivery systems to effectively address certain medical conditions. Recent studies suggest that certain compounds derived from cannabis have the potential to reduce the number and severity of epileptic seizures, reduce the muscle spasms experienced by those with multiple sclerosis, slow the progression of Alzheimer’s and Parkinson’s’ diseases and provide anxiety relief for those suffering with PTSD. Novel drug delivery systems can help safely administer and transport a pharmaceutical compound within the body to achieve its desired therapeutic effect.

AXIM Biotechnologies (OTC:AXIM) is a clinical-stage medical cannabinoid company focusing on the research, development and production of cannabis-based medical pharmaceutical products. AXIM is developing an intellectual property (IP) portfolio comprised of several proprietary delivery systems that address multiple medical indications. The company’s flagship medical cannabinoid products (CanChew+ 50™ and MedChew Rx™) deliver CBD in a controlled release manner by being administered via chewing gum.  In addition, the company is pursuing the development and sale of cannabis-based nutraceutical (CanChew Plus™) and cosmetic products. 

AXIM’S CHEWING GUM DELIVERY SYSTEM

AXIM Biotechnologies is actively engaged in conducting research in order to develop oral, trans-mucosal, controlled-release delivery systems (primarily CBD-infused chewing gum treatments) for a variety of indications. AXIM holds a patent covering the chewing gum delivery method for cannabinoids through an exclusive, 50-year, worldwide intellectual property licensing agreement with CanChew Biotechnologies, LLC.  AXIM has the option to purchase the licensed intellectual property beginning in 2020 for an amount equal to 50% of the annual royalty fee paid, which is in the range of 2%-to-3% of gross sales derived from products produced under the agreement. The company is conducting multiple preclinical and clinical studies for cannabinoid-based therapies on an array of medical conditions with the trademarked products of CanChew+® and MedChew Rx®: 

AXIM’s Phase IIa Clinical Trial for Irritable Bowel Syndrome 

In 2016, AXIM Biotechnologies began clinical studies in patients with irritable bowel syndrome (IBS) with its cannabinoid-infused CanChew+ 50™ gum (which contains 50 mg of CBD). This new formulation offers improved bioavailability over its predecessor, CanChew. By microencapsulating the active ingredient, the oral mucosal delivery system was improved by increasing the bioavailability of the CBD from less than 50% (after two hours of chewing) to 80% (after chewing for 30 minutes). The improvement was due to the microencapsulation enhancing the solubility of the CBD, bolstering its effective release into the bloodstream. Microencapsulation also helps protect the active ingredient from oxidation and degradation.

Irritable bowel syndrome is a common chronic gastrointestinal disorder that affects the large intestine. Symptoms include abdominal discomfort/pain, bloating, cramping, gas and diarrhea/constipation. The condition impairs a patient’s quality of life, which increases the prevalence of mood disorders, such as depression or anxiety.  Treatments include attempting to minimize symptoms, particularly abdominal discomfort/pain.

In 2017, AXIM began the company’s most advanced clinical trial: a 36-patient, 8-week Phase IIa study (NCT03003260) for the treatment of irritable bowel syndrome at the University of Wageningen in The Netherlands. The goal was to measure the overall pain relief in patients suffering from symptoms of IBS.  

In November 2017, the Phase II pilot trial was completed. AXIM’s mint-flavored CanChew+ 50™ was well tolerated by the patients as no significant adverse side effects were observed. All participants experienced a decrease in their pain score. The study’s trend curve indicates that patients on CanChew + experienced a 50% higher pain reduction than those on active placebo. 


 
AXIM plans to extend this 8-week study to one of longer duration with set dosing (50, 100, 200 and 300 mg CBD) at set intervals in order to determine the optimum dose and dosing regimen through pharmacokinetics (PK) and pharmacodynamics (PD) studies.

Treatment of Pain and Spasticity Associated with Multiple Sclerosis

AXIM is pursuing the use of MedChew Rx™ for the treatment of pain and spasticity associated with multiple sclerosis (MS). MedChew Rx, a mint-flavored chewing gum, contains a combination of CBD and THC (5 mg of CBD and 5 mg of THC) that has been encapsulated for improved efficacy. 

In January 2018, AXIM had an exploratory meeting with the Dutch Medicines Evaluation Board concerning the company’s MedChew Rx clinical development program for pain and spasticity associated with MS. AXIM received guidance from the Dutch Board and the necessary approvals to proceed with a clinical development program for MedChew Rx.

Under the guidance of the Dutch Medicines Evaluation Board, a 15-patient Phase I study is planned to be conducted at QPS Netherlands’ facility in Groningen. Management anticipates conducting a Phase 1 PK/PD biocomparison clinical trial comparing MedChew Rx with Sativex® (GW Pharmaceutical s’ THC/CBD oromucosal spray). Sativex is already registered for use in Europe, and the Dutch Medicines Evaluation Board has indicated it has accepted the concept of MedChew Rx potentially being an alternative option to an oral-mucosal spray product.

During the next 18 months, management anticipates completing Phase I, Phase II and Phase III clinical trials paving the way for MedChew Rx to be registered and approved for the treatment of MS with the EMA (European Medicines Agency) and by the FDA (U.S. Food and Drug Administration). 

Bioequivalence to Marinol® (dronabinol)


AXIM’s management is pursuing a plan to complete a bioequivalence trial to compare the therapeutic equivalence (both in terms of efficacy and safety) of a new dronabinol-based, controlled-release chewing gum and the reference listed drug (RLD) Marinol® (aka dronabinol). The study, officially titled A Two Part, Open Label, Randomized, Four Period Cross-over Study to Compare the Bioavailability of Two Different Dronabinol Formulations in Healthy Male and Female Volunteers, is designed as a 50-participant clinical trial, which is anticipated to start in mid-2018.  If successful, AXIM and its controlled-substance API (Active Pharmaceutical Ingredient) partner will develop a dronabinol-based, controlled-release, chewing gum product, which should receive FDA approval in a matter of months for the same indications as Marinol, namely the treatment of:

• chemotherapy-induced nausea/vomiting (CINV) and
• anorexia associated with weight loss (as an appetite stimulant), including anorexia in patients with cancer or AIDS

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 towards medical cannabis, new methods of drug administration and the results from new clinical trials. Competitors in the market include AbbVie (ABBV) with Marinol®, Akorn (AKRX) with dronabinol, PAR Pharmaceutical Companies/Endo International PLC /SVC Pharma LP (ENDP) with dronabinol and Insys Therapeutics (INSY), which in 2017 began to offer SYNDROS™ (dronabinol in an orally-administered liquid formulation). Akorn is in the process of being acquired by Fresenius Kabi AG, which is a part of Fresenius SE & Co. KGaA (DE: FRE), for approximately $4.3 billion. 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.



In December 2017, AXIM completed a Pre-Investigational New Drug Application (PIND) with the US Food and Drug Administration (FDA) in order to facilitate the approval process. The upcoming preliminary discussion should help AXIM expedite the design of the bioequivalence study between Marinol and MedChew Dronabinol®. Management anticipates conducting a bioequivalence study to compare its dronabinol-based, controlled-release chewing gum to Marinol in chemotherapy patients with nausea & vomiting and in AIDS patients experiencing appetite and weight loss.

Pain Management


The $58.6 billion global market for pain management drugs is forecast to grow to $77.1 billion by 2023. Opioids have been the major growth driver due to their efficacy in managing severe chronic pain. However, the increased use of addictive opioid pain relievers has spawned a public health crisis. The Council of Economic Advisers estimated that in 2015, the cost of opioid abuse, addiction and related deaths the U.S. was over $504 billion. And according to the Centers for Disease Control, domestic drug overdose deaths increased 22% in 2016 to over 60,000. 

New non-addictive pain management alternatives, such as medical cannabinoids, would appear to be a preferable solution. A recent study (Medical marijuana policies and hospitalizations related to marijuana and opioid pain reliever by Yuyan Shi, April 1, 2017) concluded that these new state medical marijuana policies are significantly associated with reduced opioid-related hospitalizations. However, thus far, there is not yet an FDA-approved painkiller that is derived from cannabis. 

In mid-2017, AXIM filed a patent application (Serial No. 62/410,469) with the U.S. Patent Office for chewing gum with controlled-release of cannabinoids, opioid agonists and/or opioid antagonists for the treatment of addiction and/or dependence. Within the next 18 months, management plans to start a proof-of-concept (POC) study for the treatment of opioid addiction. 

Restless Leg Syndrome 

In July 2017, AXIM Biotechnologies entered into a Services Agreement with an unnamed Israel-based Contract Research Organization to begin a clinical proof-of-concept study to treat restless leg syndrome (RLS). The study is expected to treat about 30 participants with AXIM’s chewing gum product infused with both CBD and Gabapentin. Management anticipates starting a proof-of-concept (POC) study within the next 18 months.

OTHER DRUG DELIVERY SYSTEMS 

Topical Delivery System 

AXIM’s AX-1602 topical, transdermal cannabinoid product (under the trademark ReneCann®) is being evaluated for treatment of psoriasis and atopic dermatitis (eczema). A proof-of-concept trial was completed at the Dermatological Center Maurits Clinic in The Netherlands during 2017; however, the company is attempting to develop an improved delivery platform for this topical system. 

Ophthalmic Solutions


In October 2017, the United States Patent and Trademark Office granted a patent (9,814,695) to AXIM for a cannabinoid ophthalmic solution developed for the treatment of glaucoma and symptomatic relief of conjunctivitis. Also, a Notice of Allowance (Serial Number 15/728,283) was issued by the U.S. Patent Office granted for the method to use. The patent issuance and the Notice of Allowance for the method to use set the stage for the company’s clinical trials for AX-1603 and AX-1606 by Ora, Inc., a full-service Contract Research Organization (CRO) that helps bring new ophthalmic products from concept to market. In March 2017, AXIM retained the services of Ora to help with the development of AXIM’s ophthalmic products related to glaucoma and dry eye.

AXIM’s Clinical Development Program

Below is AXIM’s most recently released drug pipeline graphic, listing the company’s numerous medical cannabinoid products and the stage of development of each one. One product (CanChew+ 50 for associated with IBS) has completed a Phase II pilot trial, and another one (MedChew Rx for pain associated with MS) has completed a Phase I for safety and dose-finding purposes with many others in preclinical stages. An improved delivery platform for the AXIM’s topical product, ReneCann® aka AX-1602, for treatment of psoriasis and atopic dermatitis is under development.

 

NUTRACEUTICAL PRODUCT

The company's flagship nutraceutical product is CanChew+, a CBD-infused chewing gum. Released in 2017, CanChew + is available in all 50 states and can be purchased online at www.canchewgum.com. Each piece of CanChew + gum contains 50 mg of CBD hemp oil and 10 mg of natural CBD (cannabidiol). 

 

On January 24, 2018, AXIM entered into a binding non-exclusive 1-year distribution agreement for CanChew+ for distribution in Thailand. 

Conclusion

AXIM Biotechnologies is a nascent specialty pharmaceutical company in the medical cannabinoid space. The company is in the process of developing medical cannabinoid solutions for the treatment of numerous diseases utilizing several delivery systems. In addition to the conditions listed above, management is targeting many other diseases, including inflammatory bowel disease (IBD), ulcerative colitis, Crohn’s disease, Parkinson’s disease, Alzheimer’s disease, dementia, attention deficit hyperactivity disorder (ADHD), PTSD and autism. Furthermore, the company intends to initiate a clinical trial for pain management on opioid-dependent patients.

We expect AXIM to continue to expand its medical cannabinoid product platform and advance a number of additional clinical programs. During the next 18 months, the company plans to complete 1) a Phase IIB clinical trial with CanChew+50 for IBS at the University of Wageningen, 2) Phase I, Phase II and Phase III clinical trials with MedChew Rx for the treatment of chronic pain and spasticity associated with multiple sclerosis and 3) a bioequivalence study to compare its dronabinol-based, controlled-release chewing gum to Marinol in chemotherapy patients with nausea & vomiting and in AIDS patients experiencing appetite and weight loss.

The marijuana industry and medical cannabis space currently are topics of considerable news flow and investor interest. AXIM’s press releases on its clinical trials will contribute to this supply of news coverage. If management successfully executes on its focused strategy and attains its goals, the company’s stock appears to offer significant upside for investors. 

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