MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has completed a pre-clinical trial measuring the anti-inflammatory effects of CimetrA™ on rodents exhibiting the cytokine storm based on three different dosages, with the company describing the results as statistically significant.
The dose-finding trial at the GLP-certified Science in Action Laboratory in Ness Ziona, Israel, was completed on 55 rodents, with the histopathology showing the reduction of lung inflammation resulting from the onset of a cytokine storm in comparison to the control group.
This study is the next step to achieve the Food and Drug Administration's (FDA) approval for the sale and distribution of CimetrA™ in the US and is also one of a cohort of studies needed to evaluate the safety and efficacy of the drug in pre-clinical and clinical models.
Key study
“The completion of this study is critical in the advancement of our submission to the FDA and for the final approval of CimetrA™ as an IND (Investigational New Drug) in the US,” MGC co-founder and managing director Roby Zomer said.
“There are further efficacy and safety trials to support our application, but these results are a key step in the demonstration of CimetrA™ as a treatment for the symptoms of the cytokine storm.”
The plant-based medical company expects to submit an IND application for CimetrA™ in the first quarter of next year.
Slowing the disease
Through these studies, the investigational drug has been shown to reduce the production of Interleukin 1α (IL-1α), an inflammatory cytokine responsible for activating the escalation of disease manifested in the form of severe acute or chronic inflammation.
Secondary test work illustrated the effect of CimetrA™ on the macrophage inflammatory protein-1 alpha (MIP-1α/CCL3), which is a chemotactic chemokine secreted by macrophages - the white blood cells that stimulate the body’s immune system.
CimetrA™ is a nanoparticle micellar formulation based on the pharmaceutical synergetic composition consisting of Curcumin and Boswellia.