MGC Pharmaceuticals, a listed company ASX, has obtained the key approval from the Australia Therapeutic Goods Administration for the start of the Phase IIB clinical trial of its "CogniCann" medical cannabis product for the treatment of dementia and Alzheimer's patients.
With this approval, the company can now begin recruiting patients for the 16-week trial at the University of Notre Dame in WA, which remains on track to start in the first half of this year. .
The study will be conducted on a total of 50 patients aged 65 or over to assess the effects of treatment on symptoms of mild dementia and Alzheimer's and on improving the patient's quality of life.
CogniCann is the second "good manufacturing practice" or certified GMP, an experimental medicinal cannabis product with a specific ratio of tetrahydrocannabinol and cannabidiol designed for the treatment of key dementia symptoms.
Separately, the company reached another important milestone after its production facility in Ljubljana, Slovenia, became one of the first in the European Union to receive permission to extract and develop its active pharmaceutical ingredients. Phytocannabinoid, or "API".
The green light of the Slovenian Ministry of Health gives MGC an advantage towards full integration for the production of its bio-pharmaceutical products.
This includes the development of new formulations with phytocannabinoids from different genetics to obtain new and new natural bees.
It also allows the company to internally produce its own APIs at a very low cost for its phytomedicine production.
MGC is also the first Australian medical cannabis company to receive the status of the European Medicines Agency for all its phytomedicines.
This provides the company with a guide to the procedures to support the research and development initiatives and the requirements to successfully obtain the authorization to be placed on the market.
It also allows MGC to request scientific advice, drug assessment and registration of CannEpil, CogniCann and all other phytomedicines currently under development.
CannEpil is a cannabis-derived drug developed to help epilepsy patients control their neurological disorder, particularly where traditional drugs and medications have had no visible impact on the condition.
In addition, the company can achieve tariff reductions of up to 100% during the process of evaluating and registering priority drugs that target unmet medical need.
The CEO of MGC, Roby Zomer, said: "We are extremely excited to see our European operations progress so considerably, in particular the expansion of our research and development capabilities, research and innovation are the lifeblood of the pharmaceutical industry and we are working hard not just to build a growing company, but to offer effective treatments to patients. "