MGC Pharma expands ArtemiC Phase II trial to include COVID-19 patients in India
MGC Pharmaceuticals已将其针对冠状病毒确诊患者的ArtemiC II期临床试验的招募范围扩大到印度奥兰加巴德的圣雄甘地使命医学院和医院。
MGC Pharmaceuticals (ASX: MXC) has confirmed the footprint of a Phase II trial into the efficacy of its ArtemiC anti-inflammatory medicated spray on the COVID-19 virus will be expanded to include the Mahatma Gandhi Mission Medical College and Hospital in India.
The company will commence recruiting patients from the hospital in Aurangabad this month for the double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of the spray.
The trial will evaluate the effects of the ArtemiC formula based on natural supplements artemisinin and curcumin (along with supporting ingredients Vitamin C and Boswellia serrata) on patients diagnosed with COVID-19.
Artemisinin and curcumin are natural active ingredients with anti-infective, anti-inflammatory, immune-modulatory and antioxidant properties.
Expanding the trial to include India will provide MGC with wider statistical data which will eventually be required to apply of marketing authorisation and product registration with the US Food and Drug Administration and European Medicines Agency.
The trial is expected to finish at year end.
India statistics
According to World Health Organisation data, almost 19,000 Indians have been diagnosed with COVID-19 in the past 24 hours, taking the country’s total confirmed cases to more than 585,000 with over 17,000 deaths to date.
WHO is currently engaging with global pharma companies conducting clinical trials on COVID-19 and selected MGC to include its ArtemiC trial in a living systematic review.
The review aims to enable decision makers to access best current evidence on comparative effects of the interventions studied in each trial.
MGC managing director Roby Zomer said the trial expansion to India could facilitate the future sale of ArtemiC in that country, and in other Asian countries which have mutual recognition with India.
“There is still a large number of new COVID-19 cases being reported on a daily basis so this trial expansion is very important to the development of ArtemiC,” he said.
“A successful clinical trial in India will be needed for [us to consider] future commercial sale of ArtemiC in that country.”
Israeli sites
COVID-19 numbers are also on the rise in Israel – in the past 24 hours, there have been 737 new cases, bringing the country’s total cases to over 24,000.
Mr Zomer said the spike has resulted in an increase in the number of new patient applications for clinical trial participation at MGC’s two active Israeli trial sites, being the Hillel Yaffe and Nazareth hospitals.
The sites are being assessed and processed for recruitment into the trial.
At midday, shares in MGC Pharmaceuticals were trading 15% higher at $0.023.