MXC.L Regulatory News (MXC)

Key Highlights:

· The patent application for CimetrATM, the Investigational Medicinal Product (IMP) assigned to MGC Pharma, has been accepted by the Slovenian Intellectual Property Office (SIPO).

· CimetrATM has been designed for multiple therapeutic applications including acute and chronic inflammation, COVID-19 and variants of influenza, autoimmune diseases, adverse events resulting from the various forms of cancer therapy, and the promotion of an immune response to bacterial, viral, fungal and parasitic infections, highlighting its versatility as a medicine.

· MGC Pharma has successfully submitted its patent application to, and was accepted by SIPO on 5 May 2021 (file number: P-202100096) which is the priority date for the patent.

· This initial patent application gives MGC Pharma priority to file subsequent patent applications for CimetrATM in other jurisdictions and other IP agencies such as EU and WIPO.

· MGC Pharma expects the patent for CimetrATM to be issued within the next 12 months.

· This patent sets out a novel pharmaceutical composition and self-nanoemulsifying drug delivery system (SNEDDS).

· CimetrATM encapsulates Graft Polymer's proprietary GraftBio™ SNEDDS technology (Self-Nano Emulsifying Drug Delivery System), a unique platform to deliver active ingredients more effectively in higher concentrations to the cells, improving the bioavailability and synergy of natural active ingredients.

· MGC Pharma continues to progress towards the commencement of its phase III clinical trial for CimetrATM in order to demonstrate the full efficacy and pharmacokinetic profile of the treatment in different variants of the COVID-19 virus.

MGC Pharmaceuticals Ltd (ASX, LSE: MXC, 'MGC Pharma' or 'the Company'), a European based bio-pharma company specialising in the production and development of phytocannabinoid-derived medicines, is pleased to announce the successful submission of a patent application for CimetrATM to the Slovenian Intellectual Property Office (SIPO), assigned to MGC Pharma.

MGC Pharma submitted its patent application which was accepted by SIPO on 5 May 2021 (file number: P-202100096) which is the priority date for the patent, giving the Company priority to file subsequent patent applications for CimetrATM in other jurisdictions and to other IP Agencies such as the EU and WIPO. MGC Pharma expects the patent to be issued within the next 12 months.

The patent provides a nano-micellular pharmaceutical synergetic composition consisting of Curcumin, Boswellia, Artemisinin, and optionally Cannabinoids and/or Nitroxides. The composition can be manufactured in liquids or in solid pharmaceutically acceptable carriers, has antioxidant, anti- inflammatory, immuno-modulating, anti-viral and anti-cancer properties and can be designed for multiple therapeutic applications, utilising self-nanoemulsifying drug delivery systems (SNEDDS).

The patent sets out the specific antioxidant, anti-inflammatory, immune-modulating, anti-viral, and anti-cancer properties of CimetrATM, designed for multiple therapeutic applications including the treatment of chronic inflammation, severe acute respiratory syndrome coronavirus (SARS-Covid, COVID-19) and heavy variants of influenza, as well as various types of cancer. This is in addition to its efficacy in relation to the regulation of the human body's circadian rhythm and homeostasis which promotes an immune response to bacterial, viral, fungal and parasitic infections. It's wide range of uses as a treatment highlights its versatility as an IMP.

Preclinical and clinical results to date support the pharmaceutical composition of CimetrATM as an effective treatment for addressing anti-inflammation and cytokine over-production (known as cytokine storm) in all tested COVID-19 patients.

Many plant molecules which make up the API are hydrophobic (not water soluble) and thus cannot be readily absorbed by the body. Once these are encapsulated within the oil-free type IV nano-micellar SNEDDS, the bioavailability of the molecules is increased and the API are emulsified and absorbed more efficiently, resulting in more effective treatment.

The submission of this patent therefore has significant implications for the pharmaceutical industry and will ultimately help to increase general drug efficiency.

MGC Pharma is advancing the clinical development program for CimetrATM as an IMP to demonstrate the full efficacy and pharmacokinetic profile of the treatment in relation to treating different variants of COVID-19, through a Phase III clinical trial that is expected to commence shortly (See 22 March 2021 announcement).

Roby Zomer, Co-founder and Managing Director of MGC Pharma, commented: "We are delighted that the SIPO recognises the unique formulation of CimetrATM, something we believe will be transformational in the treatment of COVID 19 as well as numerous other conditions. The submission of this patent application is an important next step in bringing CimetrATM to market in multiple jurisdictions and ultimately treating people and patients on a global scale whilst Phase III trials for the IMP continue.

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About MGC Pharma

MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based bio-pharma company developing and supplying affordable standardised phytocannabinoid derived medicines to patients globally. The Company's founders were key figures in the global medical cannabis industry and the core business strategy is to develop and supply high quality phytocannabinoid derived medicines for the growing demand in the medical markets in Europe, North America and Australasia. MGC Pharma has a robust product offering targeting two widespread medical conditions - epilepsy and dementia - and has further products in the development pipeline.

Employing its 'Nature to Medicine' strategy, MGC Pharma has partnered with renowned institutions and academia to optimise cultivation and the development of targeted phytocannabinoid derived medicines products prior to production in the Company's EU-GMP Certified manufacturing facility.

MGC Pharma has a number of research collaborations with world renowned academic institutions, and including recent research highlighting the positive impact of using specific phytocannabinoid formulations developed by MGC Pharma in the treatment of glioblastoma, the most aggressive and so far therapeutically resistant primary brain tumour.

MGC Pharma has a growing patient base in Australia, the UK, Brazil and Ireland and has a global distribution footprint via an extensive network of commercial partners meaning that it is poised to supply the global market.

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