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MGC Pharmaceuticals expands ArtemiC Phase II clinical trial for COVID-19 to India; selected for WHO research task force

The trial expansion will provide wider statistical data required for the application of marketing authorisation for ArtemiC with the US Food and Drug Administration and the European Medicines Agency registration.

MGC Pharmaceuticals Ltd - MGC Pharmaceuticals expands ArtemiC Phase II clinical trial for COVID-19 to India; selected for WHO research task force
In the last 24 hours, there were 18,653 new cases of COVID-19 in India

MGC Pharmaceuticals Ltd (ASX:MXC) has expanded its Phase II clinical trial for COVID-10 to India, with recruitment of patients expected to start in mid-July 2020.

In addition, the World Health Organisation (WHO) has selected MGC Pharmaceuticals to participate in its COVID-19 research task force that will enable it to obtain the latest updates and specific trial data for its living systematic review.

The trial is structured to assess the safety and efficacy of the natural anti-inflammatory formulation ArtemiC on COVID-19 infected patients and specific treatment of the cyclonic storm deterioration of the respiratory system.

ArtemiC is a natural supplement formula based on Artemisinin and Curcumin (along with supporting ingredients Vitamin C and Boswellia serrata), well-known natural active ingredients with anti-infective, anti-inflammatory, immune-modulatory and antioxidant properties.

Shares higher

MGC Pharmaceuticals shares have risen as much as 30% intra-day to 2.6 cents.

Co-founder and managing director Roby Zomer said: “We have expanded the patient recruitment process for our Phase II clinical trial to India where there is still a large number of new COVID-19 cases being reported on a daily basis.

“In addition, these wider statistical results to be obtained through the trial in India will also be required as part of the marketing authorisation application for ArtemiC.

"We look forward to updating the market as the trial commences in India.”

India trial expansion

The company said the double-blind, placebo-controlled clinical trial to evaluate ArtemiC on patients diagnosed with COVID-19 wass expected to conclude in November/December 2020.

This trial will take place at the Mahatma Gandhi Mission’s Medical College & Hospital in Aurangabad, India, where a full ethical review has been undertaken and ethics approval received.

The trial expansion will provide wider statistical data required for the application of marketing authorisation for ArtemiC with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) registration.

It will also, depending on the results of the trial, facilitate the future sale of ArtemiC in India and other Asian countries with mutual recognition with India.

In the last 24 hours, there have been 18,653 new cases of COVID-19 reported in India as of July 1, 2020, per the WHO daily situation report, taking the total COVID-19 cases in India to 585,493, with more than 17,000 deaths to date.

WHO research task force

WHO is engaging globally with pharma companies conducting clinical trials on COVID-19.

As part of this process, it has picked MGC Pharmaceuticals to participate with its ArtemiC trial to obtain the latest updates and specific trial data to include them in their living systematic review.

The aim is to enable decision-makers to access the best current evidence on comparative effects of the interventions studied in the COVID-19 trials.

Patient recruitment in Israel

The company noted that there has been an increase in COVID-19 patient applications in recent days to participate in its Phase II clinical trial at the Hillel Yaffe Hospital and Nazareth Hospital EMMS trial sites in Israel after a spike in infection rates in the country.

Following a slowdown in May/June, the number of infections has risen in the past 24 hours to 737 new cases - the highest per day since COVID-19 cases were initially reported in Israel, taking the total number of cases to over 24,000.

The patient applications are now being assessed and processed for recruitment.

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