Recent agreement with research organization initiates studies on potential cannabinoid treatments for drug-related psychosis and chemotherapy-related nausea in cancer and AIDS patients.
Medical Marijuana, Inc. investment AXIM® Biotechnologies has taken an important step toward the successful creation of cannabinoid-based treatments for a pair of medical conditions. The company has signed an agreement to begin clinical studies on a pair of leading drug candidates – MedChew® with Dronabinol and CanChew® Rx.
An innovator in cannabinoid research and development, AXIM® has entered into a Services Agreement with contract research organization (“CRO”) QPS Netherlands BV to begin separate bio comparison studies with these two products to validate their potential as new drugs.
Both products are chewing gums containing cannabinoids and utilize the company’s patented chewing gum delivery mechanism. CanChew® Rx is formulated with cannabidiol (CBD); MedChew® with Dronabinol makes use of synthetic THC.
“We look forward to continuing our support for AXIM as they conduct these studies and remain optimistic about the company’s positive future results,” said Medical Marijuana, Inc. CEO Dr. Stuart Titus. “It is very important for us to be able to prove the efficacy and safety of our products and it is great to see that two of AXIM’s developed products will be tested in these upcoming studies.”
QPS Netherlands BV is a respected global leader in contract research, making them a strong choice in CRO to conduct the necessary studies on AXIM®’s potential new drugs – CanChew® Rx and MedChew®.
“Reaching this agreement is an important step in our clinical development program as we work diligently on the many stages of trials to get our products to those suffering from a range of symptoms,” said John Huemoeller, CEO 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.”
The company will conduct two open label single dose studies that will vary chew duration and concentration to determine the best formulation and use for MedChew®. These studies will be 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 with the FDA on the basis of a 505(b)(2) application as an improved version of an existing drug.
QPS Netherlands BV will also run an open-label, randomized, three-period crossover pharmacokinetic study on AXIM®‘s CanChew® Rx to study how the CBD in this product is absorbed, processed, and excreted from the body to ensure it will be effective as a treatment option.
CanChew® Rx is intended to treat symptoms associated with drug-related psychosis. Drug-induced psychosis is when a psychotic episode is linked to the abuse of a drug. This can occur from taking too much of a certain drug, having an adverse reaction from a drug or after mixing substances, or withdrawal from a drug. Drug-related psychosis doesn’t have to be caused by illicit drugs like cocaine and methamphetamines. Common pharmaceutical medications and even alcohol can also cause psychosis.
AXIM® has developed a method for extracting and encapsulating over 99 percent pure cannabinoids. These high purity, microencapsulated cannabinoids are ideal for development into a variety of pharmaceutical applications, such as the creation of CanChew® RX.
AXIM®’s Other Areas of Research
AXIM® Biotechnologies is currently in the pre-clinical stage for cannabinoid-based new drugs for Restless Leg Syndrome and the pain and spasticity linked to Multiple Sclerosis. Both of these new drugs will take advantage of the company’s patented chewing gum delivery method for cannabinoids.
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