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news.Sets the stage for next round of financing that will eventually take the firm into clinical trials in traumatic brain injury patients in Europe and the US
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NeuroVive Pharmaceutical has completed the clinical phase of its study investigating tolerability and pharmacokinetics of the cremophor-free cyclosporine formula NeuroSTAT.
The study is entitled: “A study to compare the bioavailability and pharmacokinetics of cyclosporine after intravenous administration of NeuroSTAT, a Cremophor EL-free lipid emulsion, and Sandimmune Injection (a suspension of cyclosporine in Cremophor EL) in healthy volunteers.”
NeuroSTAT is an intravenous cyclosporine A lipid emulsion which is free from cremophor EL (castor oil) and alcohol. Cremophor EL has been reported to cause hypersensitivity reactions (anaphylaxis) in some patients. The introduction of a cremophor EL-free intravenous cyclosporine A lipid emulsion will provide a safer alternative to patients, similar to the introduction of cremophor-free Paclitaxel (Taxol) and Propofol (Diprivan) products
Eskil Elmr, CEO, said: “This study in 52 healthy subjects is a direct comparison of NeuroVive’s injectable cyclosporine product NeuroSTAT with Novartis’s product sandimmune injection. This is an important milestone in the development of NeuroVive’s product for clinical use in patients with acute brain damage.
“Further, if the final analysis of the study is successful it will open the opportunity to develop or outlicense the product NeuroSTAT for existing indications for intravenous cyclosporine A. We expect to make NeuroSTAT available for clinical trials and sales on a named-patient basis.”
Greg Batcheller, chairman, said: “The completion of this trial represents an important step in the development of NeuroSTAT. It sets the stage for a next round of financing that will eventually take us into clinical trials in traumatic brain injury patients in Europe and the US.”