MGC Pharmaceuticals' North American distribution partner submits application to Health Canada for ArtemiC™

MGC Pharmaceuticals Ltd’s (ASX:MXC) (LON:MXC) (OTCMKTS:MGCLF) Canadian-based development and North American distribution partner Glow LifeTech (CNSX:GLOW) (FRA:9DO) has submitted an application to Health Canada to obtain product licences for ArtemiC™ as a Natural Health Product (NHP). ArtemiC™ was submitted to Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) on March 11, 2021.  The application, which is under review by Health Canada, included ArtemiC™ supporting COVID-19 Phase II clinical trial results. Under Canadian regulations, all NHPs must obtain pre-market approval from Health Canada to assure they are safe, effective and of high quality before being allowed to be sold in Canada. Once Health Canada makes this assessment, they are issued a National Product Number (NPN). “Exciting step in classification of ArtemiC™” The company released the results of a successful Phase II double-blind, placebo-controlled clinical trial last year which showed ArtemiC™ statistically improved the clinical recovery of COVID-19 patients in comparison with the Placebo Group. MGC Pharma chief executive officer Roby Zomer said: “The submission of this application to Health Canada by Glow is an important and exciting step in the classification of ArtemiC™ as a Natural Health Product. “Broadening the accessibility for the treatment for symptoms of COVID-19 and will help more people suffering with the symptoms of the disease.  “Approval of Glow’s application if granted will further highlight the robustness and effectiveness of our clinical trial processes in relation to treatments that we are able to develop and bring to market.”  Safe, effective products Glow LifeTech chief commercial officer Rob Carducci said: “The global demand for natural, science-backed health products has been driven to new highs during this pandemic and Health Canada approved products are globally recognized as safe, effective and of high quality. “ArtemiC™ is supported with COVID-19 clinical results and represents a significant opportunity for Glow as a natural, safe and effective product that can be made widely accessible during these challenging times.” Phase II trial results A total of 100% of the patients in the treatment group met the trial’s primary endpoint and fully recovered within 15 days.  None of the patients supported by ArtemiC™ required additional oxygen, mechanical ventilation or intensive care, compared to 23.4% in the placebo group requiring further assistance.  The results deliver a full safety and efficacy profile, which is further supported by additional testing for toxicity and mechanism of action. Delivery system increases variability ArtemiC™ is a clinically tested oral spray containing four natural active ingredients: Artemisinin, Curcumin, Boswellia serrata, and Vitamin C.  The formulation uses the MyCell™ delivery system technology to increase bioavailability and effectiveness of natural active ingredients.  Glow LifeTech chief operating officer Tom Glawdel (PhD) said: “Glow is on a mission to unlock the healing power of plants and ArtemiC™ demonstrates the impact our unique technology can deliver.  “Our MyCell™delivery technology provides us a platform to develop a broad portfolio of scientifically validated natural ingredients to power the next generation of natural health products.”