MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) hailed as an "important milestone" the successful completion of pre-clinical rodent studies on CimetrA, its plant-based anti-inflammatory.
MGC described it as a "key step" in the pathway towards Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA), which in turn would provide the green light for clinical trials.
The evaluation, which was carried out at the Smart Assays laboratory in Israel, included the development of bioanalytical methods and validations for further pharmacokinetic analysis for CimetrA.
A study on chronic toxicity in rodents was also completed by Science in Action, in Israel, monitoring the potential development of adverse effects.
The results of the study showed the full safety profile for CimetrA across all study dosage groups and demonstrated the absence of any anomalies observed in the biopsies, nor were any clinical or behavioural adverse events recorded.
MGC managing director Roby Zomer said: "The successful completion of this study and the excellent results attained is an important milestone moment for the company, as we continue to progress CimetrA along the mandated clinical pathway.
“The results of this study are a critical step in advancing MGC's submission to the FDA, and for the final approval of CimetrA as an investigational new drug in the US."