TIDMMXC
RNS Number : 8991X
MGC Pharmaceuticals Limited
07 May 2021
07 May 2021 MGC Pharmaceuticals Ltd
ASX Code: Further findings on ArtemiC(TM) Rescue as anti-inflammatory
MXC agent for COVID-19 and post COVID-19 syndrome
LSE Code:
MXC
Key Highlights :
-- ArtemiC(TM) Rescue ( ArtemiC(TM) ) designed with the
scientific aim to target viral infections with inflammatory
complications, and was successfully evaluated on COVID-19 infected
patients in a double-blind, placebo-controlled Phase II clinical
trial.
-- Preclinical and Clinical results to date have demonstrated
ArtemiC(TM) 's mechanism of action as an anti-inflammatory and
immunomodulatory agent effective in the prevention of increased
cytokine production, found in different variants and mutations of
COVID-19; the forerunner of cytokine storm - believed to be the
main reason for mortality in severe COVID-19 patients.
-- Preclinical trial work, completed by MGC Pharma, showed the
ability of ArtemiC(TM) to decrease the markers of inflammation
(IFN-g, IL-1a and TNF-a), in the bronchoalveolar lavage fluid
(BALF) of mice in the animal model of cytokine storm related to
COVID-19 and in human trials to control the inflammation process in
COVID-19 patients.
-- Successful ArtemiCTM Phase II clinical trials performed in
India and Israel have demonstrated the capacity of ArtemiCTM to
improve and expedite the clinical recovery in mild to moderate
patients suffering from COVID-19.
MGC Pharmaceuticals Ltd (ASX, LSE: MXC, 'MGC Pharma' or 'the
Company'), a European based bio-pharma company specialising in the
production and development of phytocannabinoid-derived medicines,
is pleased to announce further results from the Phase II clinical
and preclinical studies on ArtemiC(TM) , evaluating the efficacy on
anti-inflammatory agents for increased cytokine, which is found in
different variants and mutations of COVID-19 and post COVID-19
syndrome .
The mechanism of action of ArtemiC(TM) is focused on the
anti-inflammatory effect and prevention of cytokine storm -
believed to be the main reason for mortality in COVID-19 patients.
Preclinical and clinical results to date support ArtemiC(TM) being
effective for addressing cytokine over production in all tested
COVID patients. On 15 December 2020, the Company released to the
ASX results from its Phase II clinical trial results from patients
in India and Israel.
The preclinical trial "Evaluation the Efficacy of Artemic(TM)
Treatment in ARDS Model in Mice" was performed in the SIA
preclinical Lab (GLP certified) in Israel.
The ARDC model is the recommended preclinical animal model for
the cytokine storm for the prediction of the human model of
COVID-19 patients. The level of the pro-inflammatory markers was
measured in blood and BALF (bronchoalveolar lavage fluid) of the
mice going through the cytokine storm. The results demonstrated
decreased blood and BALF cytokine levels in the study arm treated
by Artemic(TM) .
These findings support the understanding of the mechanism of
action of ArtemiC(TM) and additional potential application of the
study product. This data will be used in the design of future
clinical trials of the Company in different indications.
Following the successful Phase II clinical trial results (refer
ASX release 15 December 2020), ArtemiC(TM) demonstrated efficacy in
COVID-19 infected patients. Patients in the treatment group fully
clinically recovered within 15 days of follow up. The ArtemiC(TM)
results delivered a full safety and efficacy profile, demonstrating
its ability to improve and expedite the clinical recovery in mild
and moderate COVID-19 patients.
MGC Pharma continues the preclinical development on ArtemiC(TM)
while progressing with the clinical development program for
CimetrA(TM) as an Investigational Medicinal Product (IMP) to
demonstrate the full efficacy and pharmacokinetic profile of the
treatment in a Phase III clinical trial (submitted on the clinical
drug development program of IMP version of ArtemiC(TM) ).
Importantly once the inflammation process associated with
COVID-19 is under control, the effects of 'long COVID', the post
COVID syndrome should be minimised. MGC Pharma will initiate a
sub-trial in combination with the upcoming Phase III clinical trial
to prove this hypothesis.
As per the FDA recommendations and based on the last findings,
MGC Pharma will initiate a sub-trial for patients who complete the
Phase III trial, observing them for an additional three (3) months
to document the post COVID syndrome symptoms both in the treatment
and placebo groups.
Roby Zomer, Co-founder and Managing Director of MGC Pharma,
commented: "The findings from the phase II clinical trials which
are supported by the completed preclinical trial results, continue
to demonstrate the effectiveness of ArtemiC(TM) in treating
patients with different variants of COVID-19.
"We are now looking to get ArtemiC(TM) into more territories as
a supplement and herbal health product following these
findings."
--Ends--
Authorised for release by the Board, for further information
please contact:
MGC Pharmaceuticals Ltd UK PR Tavistock - Tavistock
Roby Zomer Charlies Vivian +44 20 7920 3150
CEO & Managing Director Charles.Vivian@tavistock.co.uk
+61 8 6382 3390 Tim Pearson +44 7983118 502
info@mgcpharma.com.au Tim.Pearson@tavistock.co.uk
UK Broker - Turner Pope Australian PR/IR Advisors - Media & Capital
Andy Thacker Partners
info@TurnerPope.com Rod Hinchcliffe (IR) +61 412 277 377
+44 20 3657 0050 Rod.Hinchcliffe@mcpartners.com.au
About MGC Pharma
MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based
bio-pharma company developing and supplying affordable standardised
phytocannabinoid derived medicines to patients globally. The
Company's founders were key figures in the global medical cannabis
industry and the core business strategy is to develop and supply
high quality phytocannabinoid derived medicines for the growing
demand in the medical markets in Europe, North America and
Australasia. MGC Pharma has a robust product offering targeting two
widespread medical conditions - epilepsy and dementia - and has
further products in the development pipeline.
Employing its 'Nature to Medicine' strategy, MGC Pharma has
partnered with renowned institutions and academia to optimise
cultivation and the development of targeted phytocannabinoid
derived medicines products prior to production in the Company's
EU-GMP Certified manufacturing facility.
MGC Pharma has a number of research collaborations with world
renowned academic institutions, and including recent research
highlighting the positive impact of using specific phytocannabinoid
formulations developed by MGC Pharma in the treatment of
glioblastoma, the most aggressive and so far therapeutically
resistant primary brain tumour.
MGC Pharma has a growing patient base in Australia, the UK,
Brazil and Ireland and has a global distribution footprint via an
extensive network of commercial partners meaning that it is poised
to supply the global market.
Follow us through our social media channels
Twitter: @MGC_Pharma
Facebook: @mgcpharmaceuticals
LinkedIn: MGC Pharmaceuticals Ltd.
Instagram: @mgc_pharma
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May 07, 2021 02:27 ET (06:27 GMT)
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