Key Highlights:
| • | Successful completion of Pre-clinical Chronic Toxicology Evaluation of CimetrA® delivers positive results, supporting previous pre-clinical and clinical data. |
| • | Study demonstrated full chronic safety and toxicology profile of CimetrA® 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 (LON:MXC) a European based pharmaceutical company specialising in the production and development of plant derived medicines, has announced positive pre-clinical trial results from the recently completed Pre-clinical Chronic Toxicology Evaluation of 14 days oral dose of CimetrA®.
The recently completed study was undertaken on 32 domestic swine, that received a study treatment (three dosages groups of CimetrA® 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® 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® 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®
CimetrA®is a nanoparticle micellar formulation based on the pharmaceutical synergetic composition consisting of Curcumin and Boswellia. In clinical trials CimetrA® 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™ Self-nano-emulsifying Drug Delivery System.
Preclinical and clinical results to date have demonstrated CimetrA®‘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.
