MGC Pharmaceuticals Ltd (ASX:MXC) has expanded a phase II double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of the natural anti-inflammatory formulation ArtemiC™ on patients diagnosed with COVID-19.
The trial has been expanded to the Rambam Hospital in Israel and the MGM Hospital in India.
Patient recruitment has started at the Rambam Academic Hospital with three patients enrolled already following receipt of Ethics Committee approval.
In India, patient recruitment has begun at the Mahatma Gandhi Mission’s Medical College & Hospital (MGM Hospital) with first patients expected to start treatment within days.
The trial is assessing the safety and efficacy of the natural anti-inflammatory formulation ArtemiC™, a natural supplement formula based on Artemisinin and Curcumin well-known natural active ingredients with anti-infective, anti-inflammatory, immune-modulatory and antioxidant properties and unique delivery system that empowers the bioactivity of the ingredients.
Additional site locations outside Israel provide MXC with the wider statistical data required as part of the process for application of marketing authorization for ArtemiC™ with the US Food and Drug Administration (FDA) and European Medical Association (EMA) registration.
“Pleased to begin clinical trial in India”
Co-founder and MD Roby Zamer said: “We are pleased to commence our clinical trial in India which will provide important wider statistical data required as part of the marketing authorization application for ArtemiCTM.
“We are also very pleased to receive the recommendation from the medical teams from the current trial which assisted with the expansion of our clinical trial in Israel to include the Rambam Hospital.
“We look forward to updating the market as the trial progresses in both Israel and India.”
Leading medical hospital in Israel
The Rambam Hospital is recognised as one of the leading medical centres in Israel providing comprehensive medical services in all medical specialties.
Ethics Committee approval followed the recent interim results received and recommendation, based on the clinical experience with COVID-19 patients, from the medical teams at current trial sites Nazareth Hospital EMMS and Hillel Yaffe Hospital.
This considerably improves the company’s access to patients to complete its trial on schedule, as Rambam Hospital is a 1,000-bed hospital serving more than two million people in northern Israel.
With 33 patients completed treatment or currently recruited across all trial sites, there are only 17 additional patients to be recruited out of the total of 50 required to complete the trial, which is on schedule to be to concluded in October with results available in November 2020.
MGC Pharma is planning a Phase IIb clinical trial to commence once this Phase II clinical trial is completed and results are analysed.