ASX-listed MGC Pharmaceuticals has received human research ethics committee approval from a second hospital in Israel to conduct a clinical trial of its natural, anti-infective “ArtemiC” formulation on COVID-19 patients, starting in the coming week.
The latest approval comes from the Hillel Yaffe Hospital in Israel and adds an additional Israeli site to conduct the Phase II study on the back of approval from the Nazareth Hospital EMMS. The Phase II study will evaluate the safety and efficacy of ArtemiC on fifty patients diagnosed with COVID-19, according to MCG Pharma.
The company said that ArtemiC is designed with the scientific aim of targeting viral infections with inflammatory complications and it will now be evaluated on the novel coronavirus 2019, or SARS-CoV-2 infected patients in a double-blind, placebo controlled, Phase II clinical trial.
The clinical trial will provide additional data for claims on ArtemiC as a food supplement and essential data to plan future trials required to achieve full marketing authorisation of ArtemiC, management said.
MGC said there is no requirement for any additional approval from the Israeli Ministry of Health to commence the trial given that it has been approved as a “Special Clinical Trial”.
The ArtemiC product encapsulates the MyCell technology that MGC now has available to it after inking a manufacturing and distribution deal with Swiss based alternative medicine group, Micelle Technology AG.
The ArtemiC formulation will make use of Micelle’s award-winning and patented, “MyCell Enhanced” delivery system technology to deliver the formulation directly inside human cells.
The company said the technology makes it possible to put a ‘skin’ over oily substances, the basic form of natural ingredients, to allow the substance to pass through the liver first, before it can start working on the body’s affected cells.