NeuroVive announces publication of the results of a Phase I clinical trial of CicloMulsion (also known under the product name NeuroSTAT), in the scientific journal Clinical Drug Investigation. The paper highlights that the intravenous cyclosporine formulation CicloMulsion demonstrates bioequivalence and improved tolerability when compared with Sandimmune Injection.
The paper, “Bioequivalence and Tolerability Assessment of a Novel Intravenous Ciclosporine Lipid Emulsion Compared to Branded Ciclosporine in Cremophor EL”, highlights that primary and secondary endpoints of the trial were met demonstrating that CicloMulsion is bioequivalent to Sandimmune Injection and is safe and well tolerated.
CicloMulsion, a Cremophor-free formulation of the cyclophilin inhibitor cyclosporine, is in clinical development by NeuroVive for the treatment of cardiac reperfusion injury. Under the name NeuroSTAT the formulation is also being developed for the treatment of traumatic brain injury. The active ingredient cyclosporine acts by preventing the death of mitochondria in damaged cells and the following cascade of intracellular biochemical events that lead to secondary tissue damage. By protecting a cell’s mitochondria, NeuroVive’s products ensure that energy production is preserved and a damaged cell’s normal regenerative mechanisms can act to repair and maintain the cell.
The paper reports the Phase I bioequivalence, safety and tolerability study in which 52 healthy volunteers were administered single intravenous doses of each of the two cyclosporine formulations in a randomized single-blind cross-over washout design. All pharmacokinetic variables (including the FDA and EMA required parameters) were within the range required to show bioequivalence.
The proportion of adverse events was significantly higher when subjects were treated with Sandimmune compared to CicloMulsion. Two serious adverse events requiring qualified medical treatment were recorded in subjects receiving Sandimmune. As a result, the study protocol was changed and all subjects received protective pre-medication. CicloMulsion was safe and well tolerated.
Release Date: December 3, 2012