TIDMMXC
RNS Number : 2017J
MGC Pharmaceuticals Limited
14 August 2023
Positive Pre-clinical Trial Results on CimetrA(R)
14 August 2023
ASX Code: MXC
LSE Code: MXC
Key Highlights:
-- Successful completion of Pre-clinical Chronic Toxicology
Evaluation of CimetrA(R) delivers positive results, supporting
previous pre-clinical and clinical data.
-- Study demonstrated full chronic safety and toxicology profile
of CimetrA(R) in large animals was found to be totally safe.
-- Trials performed under animal EC approval in the GLP certified
Lab Science in Action, Ness Ziona, Israel.
-- Study is an important step in the IND submission preparation
for the FDA and was designed and managed according to industry
guidelines.
MGC Pharmaceuticals Ltd ('MGC Pharma' or 'the Company') a
European based pharmaceutical company specialising in the
production and development of plant derived medicines, is pleased
to announce positive pre-clinical trial results from the recently
completed Pre-clinical Chronic Toxicology Evaluation of 14 days
oral dose of CimetrA(R).
The recently completed study was undertaken on 32 domestic
swine, that received a study treatment (three dosages groups of
CimetrA(R) and Placebo) for 14 days. During this period, the
clinical parameters were recorded, blood (hematology, coagulation
and chemistry) and urine tests were collected and sent to the
histopathological evaluation.
The study demonstrated that following the full chronic safety
and toxicology analysis of CimetrA(R) in large animals - the drug
was found to be safe. The histopathological analysis of the full
organs spectrum demonstrated all tissues of all animals were normal
and unaffected. It was concluded that the test article at the
dosage administered did not induce toxicological changes. No
changes in the blood and urine samples were reported.
The study was performed under animal EC approval in the GLP
certified Lab Science in Action, Ness Ziona, Israel, and is an
important step in the Investigational New Drug ("IND") submission
preparation for the US Food and Drug Administration ("FDA"). The
study was designed and managed according to industry guidelines and
the IND submission is planned for Q1 2024.
Roby Zomer, CEO and Managing Director of MGC Pharmaceuticals,
commented: "We are delighted with the positive clinical trial
results for CimetrA(R) which paves the way for our IND submission
to the FDA next year. The potential addressable market for our
anti-inflammatory and immunomodulating product is considerable and
this represents a key milestone for the business."
About CimetrA(R)
CimetrA(R) is a nanoparticle micellar formulation based on the
pharmaceutical synergetic composition consisting of Curcumin and
Boswellia. In clinical trials CimetrA(R) has demonstrated
anti-inflammatory and immunomodulating effects and can be designed
for multiple therapeutic applications utilising MGC and Graft
Polymer IP Ltd's (Graft Polymer) proprietary GraftBio(TM)
Self-nano-emulsifying Drug Delivery System.
Preclinical and clinical results to date have demonstrated
CimetrA(R)'s mechanism of action as an anti-inflammatory and
immunomodulatory agent which may be effective in the prevention of
severe inflammation by its control of increased Cytokine production
resulting from an infection of the SARS-CoV-2 (the virus
responsible for COVID- 19); and which is the forerunner of a
Cytokine Storm, which is believed to be the main reason for
mortality in severe COVID-19 patients.
-Ends-
MGC Pharmaceuticals Ltd MGC Pharmaceuticals Ltd
Roby Zomer Rowan Harland
CEO & Managing Director Company Secretary
+61 8 6555 2950 +61 8 6555 2950
info@mgcpharma.co.uk info@mgcpharma.co.uk
UK IR/PR Advisers UK Brokers
IFC Advisory Oberon Capital
Graham Herring / Tim Metcalfe Aimee McCusker / Adam Pollock
/ Zach Cohen +44 203 179 5300
+44 203 934 6630 aimeemccusker@oberoninvestments.com
mgcpharma@investor-focus.co.uk adampollock@oberoninvestments.com
Authorised for release by the board of directors, for further
information please contact:
About MGC Pharma
MGC Pharmaceuticals Ltd (LSE: MXC, ASX: MXC) is a European based
pharmaceutical company, focused on developing and supplying
accessible and ethically produced plant derived medicines,
combining in-house research with innovative technologies, with the
goal of finding or producing treatments to for unmet medical
conditions.
The Company's founders and executives are key figures in the
global pharmaceuticals industry and the core business strategy is
to develop and supply high quality plant derived medicines for the
growing demand in the medical markets in Europe, North America and
Australasia.
MGC Pharma has a robust development pipeline targeting two
widespread medical conditions and has further products under
development.
MGC Pharma has partnered with renowned institutions and academia
to optimise the development of targeted plant derived medicines, to
be produced in the Company's EU-GMP Certified manufacturing
facilities.
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:
LinkedIn: MGC Pharmaceuticals Ltd.
Twitter: @MGC_Pharma
Facebook: @mgcpharmaceuticals
Instagram: @mgc_pharma
ANNEXURE A
The CimetrA(R) large animal study was performed in the Science
in Action Laboratory in Ness Ziona, Israel, under Ethics Committee
Approval Number AHMC-IL-2302-106-2.
Science in Action is accredited for OECD principles of Good
Laboratory Practice ENV/MC/CHEM (98)17 for toxicity studies;
however, this study does not follow the complete GLP regulations,
and is thus considered a non-GLP study. The study follows this
protocol and the Science in Action SOPs. The FDA does not require
GLP for safety in vivo. As it is not mandatory to be under GLP
therefore it was decided there was no clinical or regulatory reason
to do GLP on this study.
The objective of the study was to determine the chronic
toxicological effect of oral dose (spray twice a day) of CimetrA(R)
over 14 days in swine. The study included 32 domestic swine (16
males and 16 females). Each animal was administered with the
CimetrA spray twice daily according to dosing formulations groups
listed below. At termination (14 days +/-2 days), a necropsy
consisting of examination and collection of relevant tissue/organs
was performed. Relevant tissue/organs samples were processed for
histopathology evaluation.
Study groups -
Group Dosage (per pig) (Males/Females)
Vehicle Vehicle - twice a day 4/4
1.4mg/3mg - twice a
Low Dose day 4/4
2.8mg/6mg - twice a
Mid Dose day 4/4
5.6mg/12mg - twice a
High Dose day 4/4
Hematology, coagulation and chemistry blood tests were collected
during the study. In the study termination, organs (Brain
(cerebrum), Brain (cerebellum), Brain (brain stem + medulla
oblongata), Heart (L ventricle), Heart (R ventricle), Esophagus,
Lung (R lobe), Lung (L lobe), Liver (R lobe), Liver (L lobe), Liver
(quadrate lobe), Kidneys (L), Kidneys (R), Lymph nodes
(mandibular), Lymph nodes (sup. Cervical), Lymph nodes
(mediastinal), Spleen, Ovary / Testis, Salivary Glands, Stomach,
Duodenum, Jejunum, Ileum, Colon, Cecum, Rectum, Pancreas, Tongue,
and Buccal Mucosa) were sent to the histopathology examination.
Results
No clinical signs were observed in the animals during the
trial.
No difference between study groups (treatment arms versus
placebo) was observed in the pigs weight, organs (brain, lungs,
heart, liver, spleen, kidneys) weight. The blood tests did not
demonstrate variability between study groups (treatment versus
placebo).
Based on the results we can conclude that CimetrA(R) was found
safe in animal models in two doses. These results will support the
IND submission to the FDA and future clinical studies in Phase IIb
and III. Phase IIb study includes efficacy endpoints and dose
finding elements, based on the current animal study results.
Current study results support the CimetrA(R) treatment regimen
defined in Phase IIa clinical study in COVID-19 patients and will
be used in the future clinical studies.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCKZGMRKDKGFZG
(END) Dow Jones Newswires
August 14, 2023 02:00 ET (06:00 GMT)
Mgc Pharmaceuticals (LSE:MXC)
過去 株価チャート
から 4 2024 まで 5 2024
Mgc Pharmaceuticals (LSE:MXC)
過去 株価チャート
から 5 2023 まで 5 2024