MGC Pharmaceuticals Ltd. has completed the pre-clinical rodent studies on CimetrATM, which are a key step in the clinical pathway prior to the planned FDA Investigational New Drug submission. Research using rodent and mammalian models are used to delineate the pharmacokinetic profile and general safety of a drug, as well as to identify toxicity patterns over a given period for the treatment before it advances to the next stage of trials, as required by US Food and Drug Administration criteria. The Study was undertaken to determine toxicological effects of CimetrATM over a 14-day period in rats, and was undertaken by the Smart Assays and Science in Action Laboratories in Israel, and comprised four study groups, three separate dosage groups, and one control group, with the treatment administered over a period of fourteen days, followed by a seven day review period.

Blood samples for the pharmacokinetic analysis were taken on a daily basis, and histopathology tests were conducted on all organs per FDA guidelines. No anomalies were observed in the biopsies taken, nor were any clinical or behavioural adverse events recorded. This Study is crucially important in the regulatory approval process for Investigational New Drugs approval by the FDA, and forms a key part of the metrics for the FDA's Center for Drug Evaluation and Research, the commercial and consumer watchdog, and gatekeeper to the US pharmaceutical market.

There is a strict process for FDA approval: discovery, preclinical development, and clinical trial, where the boundary between preclinical development and clinical trial is sharply defined by the IND approval. Final FDA approvals will ensure that CimetrATM meets the criteria for further clinical study and development in the US, and ultimately commercial sale, therefore opening up the largest healthcare market globally to MGC Pharma.