NeuroVive announces publication of the results of a Phase I clinical trial of lead product CicloMulsion® 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 mitochondrial medicine company NeuroVive Pharmaceutical today announces publication of the Phase I clinical study comparing CicloMulsion®, the Cremophor®-free intravenous cyclosporine formula (also known under the product name NeuroSTAT®), to Sandimmune® Injection. The results of the trial that were first announced by NeuroVive in 2010 have now been published in the peer-reviewed journal Clinical Drug Investigation.
The paper, titled "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. The full paper can be downloaded on the publisher website by accessing the following link:
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.
Eskil Elmer, CSO of NeuroVive Pharmaceutical and senior author of the publication, said:
"The publication of the results of the Phase I trial with our novel intravenous formulation for cyclosporine in this quality peer-reviewed journal is an important step of the go-to-market strategy for our products for treatment of traumatic brain injury and cardiac reperfusion injury. The trial clearly shows that our formulation is bioequivalent to Sandimmune®, yet free from Sandimmune®'s risk of causing anaphylactic and hypersensitivity reactions, thus providing a firm foundation on which to bring CicloMulsion® and NeuroSTAT® to cardiac and brain injured patients. NeuroSTAT® is expected to soon enter a Phase II clinical trial in patients with severe traumatic brain injury and CicloMulsion® is currently in a 1000-patient Phase III trial for cardiac reperfusion injury."
NeuroVive Pharmaceutical AB