Next generation pharmaceutical company MGC Pharmaceutical (ASX:MXC) reports it has completed the full preclinical rodent studies trial on its CimetrA(™) bioanalytics product.
The full preclinical rodent study was carried out at the Smart Assays laboratory in Israel and included the development of bioanalytical methods and validations for further pharmacokinetic analysis for CimetrA(™). The company notes that the studies represent a key-step in the clinical pathway prior to planned FDA Investigational New Drug submission.
It is reported the study was undertaken to determine the toxicological effects of CimetraA(™) over a 14-day period in rats and comprised 4 study groups, 3 separate dosage groups and 1 control group, with the treatment administered over the 14-days followed by a 7-day review period.
MGC Pharmaceuticals reports that no anomalies were observed in the biopsies taken and that no clinical or behavioural adverse events were recorded.
“The successful completion of this study and the excellent results attained is an important milestone moment for the company”
Speaking on the completion of the pre-clinical trial, MGC Pharmaceuticals Co-founder, Chief Executive Officer (CEO) and Managing Director Roby Zoomer 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.”
The company also notes that the study played a crucial role in the regulatory approval process for Investigational New Drugs (IND) approval by the US Food and Drug Administration (FDA), and forms a key part of the metrics for the FDA’s Centre for Drug Evaluation and Research (CDER).
MGC Pharmaceutical is an ASX-listed, European-based pharmaceutical company that is focused on developing and supplying accessible and ethically produced plant inspired medicines, combining in-house research with innovative technologies with the goal of finding or producing treatments for unmet medical conditions.
The company’s CimetrA(™) product represents a nanoparticle micellar formulation based on the pharmaceutical synergetic composition consisting of curcumin and boswellia. The product has demonstrated anti-inflammatory and immunomodulating effects throughout preclinical and clinical trials and can be designed for multiple therapeutic applications using Graft Polymer’s proprietary GraftBio(™) Self-nano-emulsifying Drug Delivery System.