MGC Pharmaceuticals (MXC) has secured a key approval in Australia to launch a phase 2 trial to evaluate CogniCann, a medicinal cannabis compounded formulation, as a potential treatment of mild Dementia and Alzheimer’s.
CogniCann is one of MXC’s medical cannabis pharmaceutical products with a THC:CBD ratio specifically formulated to treat key Dementia symptoms and enhance specific cognitive functions.
The approval was given by the Human Research Ethics Committee (HREC) at the University of Notre Dame in Western Australia (UNDA) after completion of a full ethical review.
The 16-week long trial of CogniCann will be taken up by UNDA’s Institute for Health Research and is anticipated to begin in early 2019, subject to an approval from Australia’s Therapeutic Goods Administration.
MXC co-founder and managing director Roby Zomer said: “We are pleased to have received ethics approval for our Phase II clinical trial assessing the effects of our medicinal cannabis medicine, CogniCann on patients with mild Dementia and are excited to start working with the superior team of researchers at the University of Notre Dame.”
“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.”
MXC revealed that the trial will use a randomised, double-blind, crossover, placebo-control design to assess the behavioral changes, quality of life, and level of discomfort and pain in 50 patients with dementia, aged 65 years and older, and who are put up at residential aged care facilities.
After completion of the phase 2 trial of the marijuana-based dementia drug, MXC will own all Intellectual Property (IP) and results. On the other hand, the researchers will acquire a global non-exclusive, royalty free license to use the drug’s IP for non-commercial research purposes such as research publications.
The University of Notre Dame Australia Institute for Health Research director Jim Codde said: “Health research, especially into issues affecting those most in need within our community, is of the highest priority to Notre Dame.
“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.”