MGC Pharmaceuticals has just received Ethics approval to conduct Phase II trials at a second Israel hospital to study the impacts of its unique formula on patients with COVID-19.
MGC Pharmaceuticals Ltd (ASX: MXC) has been granted a second Human Research Ethics Committee (HREC) approval from the Hillel Yaffe Hospital in Israel for an additional site to conduct a Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a natural anti-infective based formulation on patients diagnosed with COVID-19.
MGC's formulation, 'ArtemiC', is a formula based on Artemisinin and Curcumin, which are well-known natural active ingredients with anti-infective properties. The Drug was designed to target viral inflammatory infections, though the effects of the drug are now being investigated on novel coronavirus 2019 (SARS-CoV-2) infected patients in a double-blind placebo-controlled, Phase II clinical trial to be held at the Israel hospital.
This second site is an addendum to the previous Ethics Committee approval from Nazareth Hospital EMMS in Israel, which will assist MGC in attaining a greater amount of statistical data from two separate hospitals.
According to MGC's Clinical Advisory Team, led by Dr Jonathan Grunfeld and Dr Nadya Lisovoder, the current scientific data surrounding Artemisinin and Curcumin properties provide a reasonable justification in testing ArtemiC as a treatment for COVID-19.
MGC's ArtemiC is currently sold and categorized as a food supplement or nutraceutical product, requiring no new approvals or licenses. The formulation also utilizes Swiss PharmaCan AG's patented MyCell Enhanced™ delivery system technology in order to increase the bioavailability of compounds within ArtemiC.
We are anticipating the ability to produce and sell ArtemiC within a short period of time following successful completion of the Trial. Roby Zomer, Co-founder and Managing Director of MGC Pharma
Should the trials improve symptoms shown in patients diagnosed with COVID-19, MGC is aiming to achieve full marketing authorization by continuing clinical trials.
Roby Zomer, Co-founder and Managing Director of MGC Pharmaceuticals, commented: "Receiving this Ethics Committee approval to proceed immediately at a second site for the Phase II clinical trial of ArtemiC is a further endorsement of the potential the Product may have in treating the pathophysiological effects of COVID-19. This trial at an additional site will evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19 with the aim, on receipt of successful results, to move swiftly to commercial production and sales."
"Given its classification as a nutraceutical product, and therefore requiring no further approvals or licencing, we are anticipating the ability to produce and sell ArtemiC within a short period of time following successful completion of the Trial. With our GMP certified manufacturing facilities in Slovenia remaining in operation, and with sufficient capacity to produce the Product alongside our existing medications, we are moving forward with discussions with potential partners for the global distribution of ArtemiC in anticipation of the results ensuring we have agreements in place for a potential swift route to market. We look forward to updating the market with developments of the trial progress."
The results for the ArtemiC trial will be released around October, after completing the studies in September, says MGC. To learn more about MGC Pharma, visit the company HQ here.
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