ASX listed medical marijuana player MGC Pharmaceuticals has received the key ethics approval it needs to conduct phase two clinical trials into the benefits of its “CogniCann” product when used to treat dementia and Alzheimer’s patients.
CogniCann is a GMP certified, pharmaceutical grade, medicinal cannabis product with a specific ratio of tetrahydrocannabinol and cannabidiol that is specifically designed for the treatment of key dementia symptoms with a view to improving specific cognitive functions.
The 16 week West Australian based trial will be undertaken by the University of Notre Dame’s Institute for Health Research and is expected to commence in early 2019, subject to approval by Australia’s Therapeutic Goods Administration authority.
The trial will use a randomised, double-blind, crossover, placebo-control designed to evaluate the behavioural changes, quality of life and level of discomfort and pain in dementia patients living in residential aged care facilities.
MGC will own all intellectual property and results whilst the researchers will be granted a worldwide, non-exclusive, royalty free licence to use the IP for non-commercial research purposes including for publications.
The ethics approval follows the successful completion of a full ethical review undertaken by the Human Research Ethics Committee at the University of Notre Dame.
MGC Pharmaceuticals Managing Director Roby Zomer said: “We are building strong relationships in the medical research industry and see this as taking the next step in our strategic growth and development of our seed-to-pharma capabilities.”
The University of Notre Dame’s Institute for Health Research Professor Jim Codde added: “Research initiatives into dementia is also a national priority so we are very excited to work with MXC and the aged care sector to trial this novel approach to improve the quality of life for the almost 350,000 Australians suffering this disease that currently has no cure.”
CogniCann is just one GMP-certified pharmaceutical product that MGC makes within its European production and manufacturing facility, as part of its “seed-to-pharma” business model.
In July, the company received a manufacturing license for its cutting edge manufacturing facility in Slovenia to start producing cannabis based medicinal products.
This includes CannEpil, which is already approved for use in Australia and was developed to assist epilepsy sufferers to control their epilepsy, particularly in circumstances where traditional drugs are having no impact.
MGC has also experienced success with its cannabis based skin care range after UK luxury retailer Harvey Nichols extended sales to two additional stores earlier this month.
