NeuroVive Successfully Completes Clinical Trial with Cremophor-free Cyclosporine I.V. Formulation
The bioequivalence, safety and tolerability study was performed by a leading global biopharmaceutical services provider. Fifty-two healthy volunteers were administered single intravenous doses of each of the two cyclosporine formulations in a randomized single-blind cross-over washout design. Rigorous statistical analysis of measured pharmacokinetic variables established the bioequivalence of NeuroSTAT to Sandimmune Injection, meeting the primary end-point.
Sandimmune Injection subjects had an overall rate of moderate and mild side effects significantly higher than NeuroSTAT. Further, two subjects experienced anaphylactic reactions, of which one was severe, when receiving Sandimmune Injection. NeuroSTAT showed only mild side-effects, which were well tolerated. The safety and tolerability of NeuroSTAT was established, meeting the secondary end-point.
Eskil Elmer, NeuroVive CEO states: “The study results are unreservedly positive. NeuroSTAT is bioequivalent to Sandimmune, yet free from Sandimmune's risk of causing Cremophor(R) EL-related anaphylactic reactions. This is the foundation for the use of NeuroSTAT in clinical trials treating brain trauma and reperfusion injury during heart attack. It also opens commercial opportunities as a safer treatment for all existing indications where intravenous cyclosporine is used, such as organ and bone marrow transplantation.”
Cremophor(R) EL
Cremophor EL is a detergent-like agent used to keep lipophilic drugs in solution. Cremophor EL is implicated in anaphylactic reactions. For some Cremophor-containing intravenous drugs, like Taxol(R), corticosteroids are a required pre-medication to reduce risk of anaphylactic reactions. Cremophor is not present in newer drug formulations for this safety reason, including the propofol intravenous anesthetic Diprivan(R) and the paclitaxel intravenous chemotherapeutic agent Abraxane(R). NeuroSTAT(R) does not contain Cremophor(R) EL, while Sandimmune(R) Injection does.
NeuroVive website: http://www.neurovive.se
웹사이트: http://www.neurovive.com
연락처
Eskil Elmer, MD, PhD.
CEO and CSO euroVive Pharmaceutical AB (publ)
Tel. + 46 46 288 0110
Fax. + 46 46 888 8348
Cell + 46 733 919601
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