Cellmid Limited has completed its milestone preclinical studies into the efficacy of midkine (MK) for the treatment of acute myocardial infarction (AMI). Total dose of 0.18 mg/kg MK performed best and reduced the area of heart muscle damage by approximately 27 per cent when compared to untreated animals undergoing the same procedure.
These studies confirm Cellmid’s own earlier research findings that MK does indeed reduce heart damage due to ischemia and reperfusion injury.
The significant improvement demonstrated by the studies’ results mean that large animal trials can now commence. Further, manufacturing of GMP quality MK can also proceed in preparation for clinical trials.
The preclinical study was conducted by Cellmid’s collaborator, Pharmahungary, within their specialist cardiovascular research facilities. MK was given to rats intravenously in single doses and in follow up intravenous infusions. MK was also safe and well tolerated, with no difference in adverse events between MK treated and untreated controls.
“A reduction of around 27 per cent in infarct size is very encouraging”, said CEO of Pharmahungary, Dr Peter Ferdinandy. “Pharmahungary’s study was extremely rigorous. Samples were blinded for analysis and the area of heart muscle death was measured using their state-of-the-art imaging software Infarctsize” added Cellmid’s Head of Product Development, Darren Jones.
As well as conducting the pivotal MK efficacy study, Pharmahungary also evaluated MK in dose-ranging and acute safety/tolerability studies. Dose-ranging studies showed that MK was effective at significantly reducing heart muscle death with doses between 0.1mg/kg and 1.0 mg/kg. Furthermore, MK was safe and well tolerated at doses 16 times greater than the most effective dose of 0.18 mg/kg, with no cardiovascular toxicities observed.