TIDMMXC
RNS Number : 0053T
MGC Pharmaceuticals Limited
22 March 2021
22 March2021 MGC Pharmaceuticals Ltd
ASX Code: Ethics Committee Approval Granted for Phase III Clinical
MXC Trial of CimetrA(TM) on Patients Diagnosed with COVID-19
LSE Code:
MXC
Key Highlights :
-- MGC Pharma has received Ethics Committee approvals from
Rambam Health Care Campus, Haifa and Nazareth Hospital EMMS in
Israel, for the Phase III clinical trial to be undertaken on
patients diagnosed with COVID-19 ("Trial").
-- CimetrA(TM) is designed with the scientific aim to target
viral infections with inflammatory complications and was
successfully evaluated on COVID-19 (SARS-CoV-2) infected patients
in a double-blind placebo controlled, Phase II clinical trial.
-- MGC is fully funded to complete the Trial following the LSE
IPO GBP6.5m raising in February 2021.
-- The Trial will evaluate the efficacy and safety of
CimetrA(TM) in the treatment of moderate hospitalised patients
diagnosed with COVID-19 on a large patient group.
-- The name change to CimetrA(TM) recognises the transfer of
product under the Phase III clinical trial to an Investigational
Medicinal Product ("IMP") status, while ArtemiC(TM) will remain as
a food supplement.
-- CimetrA(TM) encapsulates Graft Polymer's proprietary
GraftBio(TM) SNEDDS technology (Self-Nano Emulsifying Drug Delivery
System) , a unique platform to deliver active ingredients more
effectively in higher concentrations to the cells, improving the
bioavailability of natural active ingredients.
-- The Trial will provide additional data for claims on the
product as an IMP and provide essential data to plan for the future
regulatory pathway for the registration of CimetrA(TM) as a
drug.
-- The Trial is expected to commence in early April and conclude
in September 2021, with interim results expected in June and full
study results in October 2021.
-- This Phase III clinical trial is currently going through
regulatory approvals for additional clinical sites in Israel and
Brazil.
-- MGC Pharma already has the required facilities, permits and
approvals to start production of CimetrA(TM) as an IMP.
-- MGC Pharma is planning a CimetrA(TM) development program that
will support pre-clinical and clinical trials in additional
inflammatory and autoimmune indications.
MGC Pharmaceuticals Ltd (ASX, LSE: MXC, 'MGC Pharma' or 'the
Company'), a European based bio-pharma company specialising in the
production and development of phyto-derived medicines, is pleased
to announce it has been granted Ethics Committee approval from
Rambam Health Care Campus and Nazareth Hospital EMMS in Israel, to
conduct a Phase III Clinical Trial (the Trial ) to evaluate the
efficacy and safety of CimetrA(TM) as a treatment for moderate
hospitalised patients diagnosed with COVID-19 and to provide
additional data for claims on the product as an IMP. The Trial is
now scheduled to commence in early April, and will provide
essential data to plan for the potential future registration of
CimetrA(TM) as a drug.
Under the move to a Phase III clinical trial, the classification
of the product has changed from a food supplement to an IMP. As a
result, the product name under the Trial has changed from
ArtemiC(TM) to CimetrA(TM) . ArtemiC(TM) will remain as a food
supplement and available under the master distribution agreement
with Swiss Pharmacann, while CimetrA(TM) becomes an IMP which will
include changing the drug carrier to a new polymeric drug carrier
GraftBio(TM) (SNEDD - Self Nano Drug Delivery), with a view to
potentially being registered as a drug in the future.
Phase III Clinical Trial Approval Granted from two Israeli
Hospitals
The Company has received two independent Ethics Committee
approvals granted by Rambam and EMMS Hospitals in Israel to conduct
the Phase III placebo controlled clinical trial on patients
diagnosed with COVID-19. The Phase III clinical trial approvals
from Rambam and EMMS Hospitals is the result of the successful
completion of a full ethical review undertaken by the respective
Human Research Ethics Committees following the successful
completion of the Phase II trial announced on 15 December 2020
.
Rambam Health Care Campus is a 1000-bed world-class Governmental
teaching hospital. The patient population is diverse, as Rambam is
the major tertiary (referral) medical centre for all of Northern
Israel serving more than two million residents and others referred
from all over Israel, the Mediterranean region, and around the
world.
The Nazareth Hospital EMMS is one of the oldest hospitals in the
Middle East, and the largest in Nazareth. EMMS is a general
hospital with Nazareth's main Emergency Room that works 24/7, ICU,
a recently refurbished Cath Lab, Orthopaedic Surgical department,
General Surgical department, Pediatric surgical unit, Urology Unit
and Esthetic Clinic. The hospital has a Medical department with
Tuberculosis and Cardiac clinics, as well as a Dialysis unit,
Psychiatry Department, Delivery rooms, a unique Neonate unit,
Gastrology unit, X-ray department and other medical clinics that
serve tens of thousands of patients every year.
Phase III Clinical Trial
The Phase III clinical trial which has been approved by the
Ethics Committee from Rambam and EMMS Hospitals, Israel, is
designed to test CimetrA(TM) on moderate hospitalised patients
infected with COVID-19 for safety and efficacy, with the purpose of
treating the pathophysiological repercussions of infection with the
novel coronavirus 2019 (SARS-CoV-19). The Phase III clinical trial
will assess the efficacy and safety of the natural
anti-inflammatory formulation CimetrA(TM), based on Curcumin and
Boswellia Serrata as Anti-inflammatory agents with the supporting
ingredient Artemisinin as an Antiseptic peroxide bridge, which are
all well-known natural active ingredients with immunomodulatory
properties (see full detail in ASX Announcement 17 April 2020).
The protocols for this Trial were finalized by the MGC Pharma
Clinical Advisory Team, led by Dr Grunfeld and Dr Lisovoder, and
provided to the Ethics Committee for approval, which has now been
received. As recently announced, due to the definition of the Trial
being a "Special Clinical Trial", there is no requirement for any
additional approval from the Israeli Ministry of Health to commence
the Trial.
The Trial is expected to commence in early April, with placement
of the clinical trial insurance now complete, and is to be
evaluated on a total target number of 252 patients infected with
COVID-19, across clinical sites in Israel and Brazil. The interim
Trial results are expected to be received and published by June
2021.
The Trial will be conducted over a period of 28 days per patient
and is expected to conclude during September 202 1 , with results
available during October 202 1 . Full details on the Phase I I I
clinical trial required for compliance with the ASX Code of Best
Practice for Reporting by Life Science Companies are included in
Annexure A, with minor updates to the selection criteria
included.
Roby Zomer, Co-founder and Managing Director of MGC Pharma,
commented: "This is a very significant milestone for the Company
being the first Phase III clinical trial of CimetrA(TM) .
ArtemiC(TM) has already proven to be a very successful product for
the Company, and we look forward to replicating this with
CimetrA(TM) as an IMP and improve outcomes for COVID-19
patients."
--Ends--
Authorised for release by the Board, for further information
please contact:
MGC Pharmaceuticals Ltd UK PR Advisors - Tavistock
Roby Zomer Charles Vivian
CEO & Managing Director +44 207 920 3150
+61 8 6382 3390 Charles.Vivian@tavistock.co.uk
info@mgcpharma.com.au Tim Pearson
+44 7983118 502
Tim.Pearson@tavistock.co.uk
UK Broker - Turner Pope Australian PR/IR Advisors - Media
Andy Thacker & Capital Partners
Andy.Thacker@TurnerPope.com Rod Hinchcliffe (IR) +61 412 277
Zoe Alexander 377
Zoe.Alexander@TurnerPope.com Rod.Hinchcliffe@mcpartners.com.au
+44 20 3657 0050
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
ANNEXURE A
Name and any unique identifier A Phase III, double-blind, controlled
of the trial: clinical study designed to evaluate
the effect of CimetrA(TM) in patients
diagnosed with COVID-19 ("Trial")
Primary endpoint(s): Time to sustained clinical improvement,
defined as a national Early Warning
Score 2 (NEWS2) of 2 Maintained
for 24 Hours in comparison to
routine treatment (measured on
days 7, 14, 28)
-----------------------------------------------------------------
Secondary endpoints:
* Number of participants with depending on oxygen
supplementation through day 28 since onset of
symptoms
* Change in inflammatory marker levels - IL-6, IL-1,
IL-12, TNF , IFN-, CRP, NLR (Neutrophil / Lymphocyte
ratio) at days 1, 2, 4, 7, compared to baseline
* Pharmacokinetic profile of the study drug
* Incidence and duration of mechanical ventilation
* Incidence of Intensive Care Unit (ICU) stay during
COVID-19 complication
* Percentage of participants with definite or probable
drug related adverse events
* Long-term adverse events of COVID-19 on Day 28
* Quality of life of patients on Days 0, 14 and 28.
* The exploratory outcomes:
* Course of change in D Dimer levels compared to
baseline
* Occurrence of secondary infections
-----------------------------------------------------------------
Blinding status: Double Blinded
-----------------------------------------------------------------
Product status: The Product will be packaged and
labelled in compliance with Good
Manufacturing Practice (GMP)
-----------------------------------------------------------------
Treatment method, route, frequency, Study Product -
dose levels: Arm 1: CimetrA-1, with a total
dose containing a combination
of Artemisinin 12 mg, Curcumin
40 mg, Boswellia 30 mg and Vitamin
C 120 mg in spray administration
- divided in 4 separate doses
given as an add on therapy, 4
doses over 48 hours (day 1 and
day 2), twice a day (morning and
evening).
Arm 2: Placebo, composed of the
same solvent but without active
ingredients, given as an add on
therapy in spray administration,
4 doses over 48 hours (day 1 and
day 2), twice a day (morning and
evening).
Study Procedures: The study will
last 4 weeks and additional time
required for follow up till hospital
discharge in order to check side
effects and study drug efficacy.
Methodology : Multi-centre multinational-controlled
study.
252 adult patients who suffer
from moderate COVID-19 infection.
Safety will be assessed through
collection and analysis of adverse
events, blood and urine laboratory
assessments and vital signs.
After Screening visit, the study
drug will be administrated twice
a day morning and evening (every
12 hours) during (day 1 and day
2)
The patients will be randomized
in 1:1 ratio to study drug (CimetrA(TM)
) in addition to Standard of Care
(Arm 1) or to Placebo in addition
to Standard of Care (Arm 3).
-----------------------------------------------------------------
Number of trial subjects: Total of 252 adult patients, across
Israel and Brazil , who suffer
from COVID-19 infection
-----------------------------------------------------------------
Description of Control Group: Placebo + Standard of Treatment
-----------------------------------------------------------------
Subject selection criteria: Inclusion Criteria:
-- Confirmed SARS-CoV-2 infection
-- Hospitalised COVID-19 patient
in stable moderate condition (i.e.,
not requiring ICU admission)
-- Age - 18 and above
-- NEWS2 Score of 4 or above
-- Ability to receive treatment
by spray into the oral cavity.
-- Subjects must be under observation
or admitted to a controlled facility
or hospital (home quarantine is
not sufficient)
Exclusion Criteria:
-- Tube feeding or parenteral
nutrition.
-- Respiratory decompensation
requiring mechanical ventilation
-- Uncontrolled diabetes type
2
-- Autoimmune disease
-- Pregnant or lactating women
-- Any condition which, in the
opinion of the Principal Investigator,
would prevent full participation
in this trial or would interfere
with the evaluation of the trial
endpoints.
-----------------------------------------------------------------
Trial locations: Multiple Sites in Israel and Brazil
-----------------------------------------------------------------
Name of the principal investigator: Dr Ameer Elemy (Nazareth Hospital
EMMS)
Dr. Shadi Hamoud
-----------------------------------------------------------------
Partners: Galilee-CBR (CRO)
-----------------------------------------------------------------
Expected duration: The Trial is expected to commence
in the coming week and conclude
around September 202 1 with results
then available in October 202
1
-----------------------------------------------------------------
Additional information: Not applicable.
-----------------------------------------------------------------
Trial standard: This clinical trial will be conducted
in compliance with Good Clinical
Practices (GCP)
-----------------------------------------------------------------
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END
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