Friday, April 17, 2020 7:58:24 AM
https://themarketherald.com.au/mgc-pharmaceuticals-asxmxc-receives-phase-ii-trial-approval-for-covid-19-patients-2020-04-17/?fbclid=IwAR3SJ9Okpd9XHjtBCOEJv8CCQ9uaTMxT5WrLtosJNOmak7tFss0SPMfh-uI
Ashleigh Melanko
Markets Reporter
ashleigh.melanko@themarketherald.com.au
17 April 2020 13:09
MGC Pharma (ASX:MXC) - Co Founder and Managing Director, Roby Zomer - The Market Herald
Co Founder and Managing Director, Roby Zomer
Sourced: FinFeed
MGC Pharmaceuticals (MXC) will be conducting a Phase II placebo-controlled clinical trial to evaluate the safety and efficacy of ArtemiC in COVID-19 patients
This trial follows the company's recent approval from an Israel-based hospital
ArtemiC, which is a natural anti-infective formulation, is used to target viral infections
The trial is expected to begin this month and finish in September
Results will then be available the following month
Despite there being a pause in trade, MGC Pharma shares have soared 36 per cent and are currently trading for 3.4 cents each
MGC Pharmaceuticals (MXC) will be conducting a Phase II placebo-controlled clinical trial to evaluate the safety and efficacy of ArtemiC in COVID-19 patients.
This trial comes after the company was granted Human Research Ethics Committee approval from Nazareth Hospital EMMS in Israel.
Due to the trial being classified as a "Special Clinical Trial", no more approvals need to be granted before it can begin.
On April 4 2020, MGC Pharma entered a binding agreement with Micelle Technology to provide research support, and commercial manufacturing and distribution of the product.
ArtemiC is a natural, anti-infective formulation that is made up of Artemisinin (a drug derived from a fern-like plant and is used against malaria) and Curcumin (bright yellow chemical which provides anti-inflammatory and antioxidant effects).
It is then mixed with Vitamin C and Boswellia serrata (herbal extract used to treat inflammatory illnesses) as taking Artemisinin by itself may do more harm than good.
Both MGC Pharma and Micelle have begun planning for testing programs to evaluate ArtemiC's anti-infective, anti-viral and anti-inflammatory properties, including on patients with COVID-19.
The Trial
The Phase II trial will evaluate the safety and efficacy of ArtemiC in patients with COVID-19.
The trial is expected to begin this month, following the recruitment of 50 patients with COVID-19.
The trial will be conducted over a period of two weeks per patient and it is expected to finish in September 2020 with results available in October 2020.
If the trial is successful then both MGC Pharma and Micelle will make a decision, based off the results, about future trials.
The end goal for both companies is to achieve full marketing authorisation, however, it was announced that successful outcomes do not necessarily guarantee regulatory approval.
If the trial is unsuccessful then MGC Pharma will examine the results and decide whether to proceed.
"Following our recently announced agreement with Micelle, this approval to proceed immediately with a Phase II clinical trial of ArtemiC is a major milestone," Co-Founder and Managing Director Roby Zomer commented.
"This trial will evaluate the safety and efficacy of ArtemiC on patients diagnosed with COVID-19 and we look forward to updating the market with developments," he added.
Despite there being a pause in trade, MGC Pharma shares have soared 36 per cent and are trading for 3.4 cents each at 12:45 pm AEST.
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